Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses (open access)

Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses

A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), regulates the promotion of prescription drugs to ensure that promotional materials are not false and misleading and that they comply with applicable laws and regulations. Among other things, FDA prohibits drug companies from promoting drugs for off-label uses--that is, for a condition or patient population for which the drug has not been approved or in a manner that is inconsistent with information found on the approved drug label. Although doctors may prescribe drugs off label, it is not permissible for drug companies to promote drugs for off-label uses. FDA may take regulatory actions for violations, and may also pursue enforcement action through the Department of Justice (DOJ). GAO was asked for information about the promotion of drugs for off-label uses. GAO reviewed (1) how FDA oversees the promotion of off-label uses of prescription drugs and (2) what actions have been taken to address off-label promotions. GAO examined documentation related to the promotion of drugs for off-label uses and FDA correspondence with drug companies on identified violations and obtained information …
Date: July 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Disconnected Youth: Federal Action Could Address Some of the Challenges Faced by Local Programs That Reconnect Youth to Education and Employment (open access)

Disconnected Youth: Federal Action Could Address Some of the Challenges Faced by Local Programs That Reconnect Youth to Education and Employment

A letter report issued by the Government Accountability Office with an abstract that begins "While most young people successfully transition to adulthood, a significant number of youth are disconnected from school and employment. These youth are more likely than others to engage in crime, become incarcerated, and rely on public systems of support. Several federal agencies oversee a number of programs and grants that assist local programs in serving this population at the local level. GAO reviewed the following: (1) characteristics of locally operated programs that serve disconnected youth, (2) the key elements of locally operated programs to which directors attribute their success in reconnecting youth to education and employment, and (3) challenges involved in operating these programs and how federal agencies are helping to address these challenges. GAO interviewed officials from four federal agencies, experts, and directors of 39 local programs identified by agencies and experts as helping youth meet educational and employment goals."
Date: February 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
DOD Business Systems Modernization: Key Marine Corps System Acquisition Needs to Be Better Justified, Defined, and Managed (open access)

DOD Business Systems Modernization: Key Marine Corps System Acquisition Needs to Be Better Justified, Defined, and Managed

A letter report issued by the Government Accountability Office with an abstract that begins "GAO has designated the Department of Defense's (DOD) business systems modernization as a high-risk program because, among other things, it has been challenged in implementing key information technology (IT) management controls on its thousands of business systems. The Global Combat Support System-Marine Corps program is one such system. Initiated in 2003, the program is to modernize the Marine Corps logistics systems. The first increment is to cost about $442 million and be deployed in fiscal year 2010. GAO was asked to determine whether the Department of the Navy is effectively implementing IT management controls on this program. To accomplish this, GAO analyzed the program's implementation of several key IT management disciplines, including economic justification, earned value management, risk management, and system quality measurement."
Date: July 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Check 21 Act: Most Consumers Have Accepted and Banks Are Progressing Toward Full Adoption of Check Truncation (open access)

Check 21 Act: Most Consumers Have Accepted and Banks Are Progressing Toward Full Adoption of Check Truncation

A letter report issued by the Government Accountability Office with an abstract that begins "Although check volume has declined, checks still represent a significant volume of payments that need to be processed, cleared, and settled. The Check Clearing for the 21st Century Act of 2003 (Check 21) was intended to make check collection more efficient and less costly by facilitating wider use of electronic check processing. It authorized a new legal instrument--the substitute check--a paper copy of an image of the front and back of the original check. Check 21 facilitated electronic check processing by allowing banks to use electronic imaging technology for collection and create substitute checks from those images for delivery to banks that do not accept checks electronically. Check 21 mandated that GAO evaluate the implementation and administration of the act. The report objectives are to (1) determine the gains in economic efficiency from check truncation and evaluate the benefits and costs to the Federal Reserve System (Federal Reserve) and financial institutions; (2) assess consumer acceptance of the check truncation process resulting from Check 21; and (3) evaluate the benefits and costs to bank consumers from check truncation. GAO analyzed costs for the check operations of the …
Date: October 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Centers for Disease Control and Prevention: Human Capital Planning Has Improved, but Strategic View of Contractor Workforce Is Needed (open access)

Centers for Disease Control and Prevention: Human Capital Planning Has Improved, but Strategic View of Contractor Workforce Is Needed

A letter report issued by the Government Accountability Office with an abstract that begins "The Centers for Disease Control and Prevention (CDC)--an agency in the Department of Health and Human Services (HHS)--has experienced an expanding workload due to emerging health threats, such as bioterrorism. Strategic planning helps agencies like CDC sustain a workforce with the necessary education, skills, and competencies--human capital--to fulfill their missions. In September 2007, CDC released its Strategic Human Capital Management Plan (CDC Plan). GAO was asked to review CDC's human capital planning. GAO determined (1) whether the CDC Plan was designed to address the human capital challenges CDC faces; (2) the extent to which the CDC Plan is strategically aligned with agency goals, plans, and budget; and (3) the extent to which CDC incorporated GAO's principles for strategic human capital planning. To do so, GAO interviewed officials and analyzed data and documents."
Date: May 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Foreign Investment: Laws and Policies Regulating Foreign Investment in 10 Countries (open access)

Foreign Investment: Laws and Policies Regulating Foreign Investment in 10 Countries

A letter report issued by the Government Accountability Office with an abstract that begins "Foreign acquisitions of U.S. companies can pose a significant challenge for the U.S. government because of the need to balance the benefits of foreign investment with national security concerns. The Exon-Florio amendment to the Defense Production Act authorizes the President to suspend or prohibit foreign acquisitions of U.S. companies that may harm national security. To better understand how other countries deal with similar challenges, GAO was asked to identify how other countries address the issues that Exon-Florio is intended to address. Specifically, this report describes selected countries' (1) laws and policies enacted to regulate foreign investment to protect their national security interests and (2) implementation of those laws and policies. This report updates a 1996 GAO report that describes how four major foreign investors in the United States--France, Germany, Japan, and the United Kingdom--monitored foreign investment in their own countries to protect national security interests. It also examines foreign investment in six additional countries: Canada, China, India, the Netherlands, Russia, and the United Arab Emirates (UAE). GAO reviewed selected laws and regulations and interviewed foreign government officials and others concerning their implementation and any planned changes …
Date: February 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Commonwealth of the Northern Mariana Islands: Pending Legislation Would Apply U.S. Immigration Law to the CNMI with a Transition Period (open access)

Commonwealth of the Northern Mariana Islands: Pending Legislation Would Apply U.S. Immigration Law to the CNMI with a Transition Period

A letter report issued by the Government Accountability Office with an abstract that begins "The Commonwealth of the Northern Mariana Islands (CNMI) is subject to most U.S. laws but, under the terms of its 1976 covenant with the United States, administers its own immigration system. It has applied this flexibility to admit substantial numbers of foreign workers, in addition to admitting tourists and foreign investors. The covenant grants Congress the right to apply federal immigration law to the CNMI. On December 11, 2007, the House of Representatives passed legislation applying U.S. immigration law to the CNMI; as of report issuance, this legislation was pending in the Senate. If passed, it will amend the covenant and will apply federal immigration law to the CNMI 1 year after the legislation's enactment, subject to a transition period that begins 1 year after enactment but may be delayed 180 days. GAO was asked to review key provisions of the pending legislation, current U.S. immigration law, and current CNMI immigration law, particularly regarding (1) foreign workers, (2) tourists, and (3) foreign investors. The Departments of Homeland Security and the Interior generally agreed with the findings in this report, and the Department of Labor provided no …
Date: March 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
VA Health Care: Additional Efforts to Better Assess Joint Ventures Needed (open access)

VA Health Care: Additional Efforts to Better Assess Joint Ventures Needed

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Veterans Affairs (VA) and the Department of Defense (DOD) have a long history of partnering to achieve more cost-effective use of health care resources. Their partnerships have evolved to include joint ventures--joint efforts to construct or share medical facilities. VA has maintained eight joint ventures with DOD across the country. VA has also developed partnerships, or affiliations, with university medical schools to obtain health care services for veterans and provide training to medical residents. VA has not entered into a joint venture with an academic affiliate to date. However, several proposals for such joint ventures have surfaced in the last decade. This congressionally requested report discusses the (1) potential benefits and concerns associated with joint ventures and the extent to which they are documented and measured, (2) lessons learned from existing and proposed VA joint ventures, and (3) steps VA has taken to evaluate proposed joint ventures. To address these issues, GAO conducted site visits to and interviews with officials from all existing and proposed joint venture sites."
Date: March 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Health Insurance: Most College Students Are Covered through Employer-Sponsored Plans, and Some Colleges and States Are Taking Steps to Increase Coverage (open access)

Health Insurance: Most College Students Are Covered through Employer-Sponsored Plans, and Some Colleges and States Are Taking Steps to Increase Coverage

A letter report issued by the Government Accountability Office with an abstract that begins "College students face challenges obtaining health insurance--they may not have access to insurance through an employer, and as they get older, they may lose dependent coverage obtained through a parent's plan. Federal law ensures continued access to health insurance for some, but not all, such students. Without health insurance, college students may be unable to pay for their health care, and the cost of this care may be passed on to federal and state payers, such as Medicaid. College students may have access to student insurance plans offered by their colleges. GAO was asked to report on uninsured college students, student insurance plans, and efforts to increase the number of insured students. GAO reviewed (1) college students' insurance status, (2) uninsured college students' characteristics, (3) the extent to which colleges offered student insurance plans and the characteristics of available plans, and (4) efforts to increase the number of insured students. GAO analyzed data from a national survey on college students' insurance status and uninsured college students' characteristics. GAO collected data from 340 colleges on the availability of student insurance plans and the characteristics of available plans, …
Date: March 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Chemical and Biological Defense: DOD and VA Need to Improve Efforts to Identify and Notify Individuals Potentially Exposed during Chemical and Biological Tests (open access)

Chemical and Biological Defense: DOD and VA Need to Improve Efforts to Identify and Notify Individuals Potentially Exposed during Chemical and Biological Tests

A letter report issued by the Government Accountability Office with an abstract that begins "Tens of thousands of military personnel and civilians were potentially exposed to chemical or biological substances through Department of Defense (DOD) tests since World War II. DOD conducted some of these tests as part of its Project 112 test program, while others were conducted as separate efforts. GAO was asked to (1) assess DOD's efforts to identify individuals who were potentially exposed during Project 112 tests, (2) evaluate DOD's current effort to identify individuals who were potentially exposed during tests conducted outside of Project 112, and (3) determine the extent to which DOD and the Department of Veterans Affairs (VA) have taken action to notify individuals who might have been exposed during chemical and biological tests. GAO analyzed documents and interviewed officials from DOD, VA, the Department of Labor, and a veterans service organization."
Date: February 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
VA Health Care: Facilities Have Taken Action to Provide Language Access Services and Culturally Appropriate Care to a Diverse Veteran Population (open access)

VA Health Care: Facilities Have Taken Action to Provide Language Access Services and Culturally Appropriate Care to a Diverse Veteran Population

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Veterans Affairs (VA) faces challenges in bridging language and cultural barriers as it seeks to provide quality health care services to an increasingly diverse veteran population in terms of race, ethnicity, sex, and age. To meet the needs of veterans with limited English proficiency (LEP), VA issued an LEP Directive that provides guidance for medical centers in assessing language needs and, if needed, developing language access services designed to ensure effective communication between English-speaking providers and those with LEP. In addition, VA is also challenged to deliver health care services in ways that are culturally appropriate--that is, respectful of and responsive to the cultural values of a diverse veteran population. In light of these challenges, GAO was asked to discuss the (1) actions VA has taken to implement its LEP Directive and the status of veterans' utilization of language access services, and (2) efforts VA has made to provide culturally appropriate health care services. GAO reviewed VA's policies and the LEP Directive, interviewed VA officials and reviewed efforts by 6 VA medical centers and 10 other VA facilities to implement VA's LEP Directive …
Date: May 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Electronic Health Records: DOD and VA Have Increased Their Sharing of Health Information, but More Work Remains (open access)

Electronic Health Records: DOD and VA Have Increased Their Sharing of Health Information, but More Work Remains

A letter report issued by the Government Accountability Office with an abstract that begins "Under the National Defense Authorization Act for Fiscal Year 2008, the Department of Defense (DOD) and the Department of Veterans Affairs (VA) are required to accelerate the exchange of health information between the departments and to develop systems or capabilities that allow for full interoperability (generally, the ability of systems to use data that are exchanged) and that are compliant with federal standards. The act also established a joint interagency program office to act as a single point of accountability for the effort, whose function is to implement such systems or capabilities by September 30, 2009. Further, the act required that GAO semi-annually report on the progress made in achieving these goals. For this first report, GAO describes the departments' progress to date in sharing electronic health information, developing electronic health records that comply with federal standards, and setting up the joint interagency program office. To do so, GAO reviewed its past work, analyzed agency documentation, and conducted interviews with agency officials."
Date: July 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Electronic Waste: EPA Needs to Better Control Harmful U.S. Exports through Stronger Enforcement and More Comprehensive Regulation (open access)

Electronic Waste: EPA Needs to Better Control Harmful U.S. Exports through Stronger Enforcement and More Comprehensive Regulation

A letter report issued by the Government Accountability Office with an abstract that begins "Increasingly, U.S. consumers are recycling their old electronics to prevent the environmental harm that can come from disposal. Concerns have grown, however, that some U.S. companies are exporting these items to developing countries, where unsafe recycling practices can cause health and environmental problems. Items with cathode-ray tubes (CRT) are particularly harmful because they can contain 4 pounds of lead, a known toxin. To prevent this practice, since January 2007 EPA began regulating the export of CRTs under its CRT rule, which requires companies to notify EPA before exporting CRTs. In this context, GAO examined (1) the fate of exported used electronics, (2) the effectiveness of regulatory controls over the export of these devices, and (3) options to strengthen federal regulation of exported used electronics. Among other things, GAO reviewed waste management surveys in developing countries, monitored e-commerce Web sites, and posed as foreign buyers of broken CRTs."
Date: August 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library
Tax Gap: Actions That Could Improve Rental Real Estate Reporting Compliance (open access)

Tax Gap: Actions That Could Improve Rental Real Estate Reporting Compliance

A letter report issued by the Government Accountability Office with an abstract that begins "As part of its most recent estimate of the tax gap, for tax year 2001, the Internal Revenue Service (IRS) estimated that individuals underreported taxes related to their rental real estate activities by as much as $13 billion. Given the magnitude of underreporting, even small improvements in taxpayer compliance could result in substantial revenue. GAO was asked to provide information on rental real estate reporting compliance. This report (1) provides information on the extent and primary types of taxpayer misreporting of rental real estate activities and (2) identifies challenges IRS faces in ensuring compliance and assesses options for increasing compliance. For estimates of taxpayer misreporting, GAO analyzed a probability sample of examination cases for tax year 2001 from IRS's most recent National Research Program (NRP) study of individual taxpayer compliance."
Date: August 28, 2008
Creator: United States. Government Accountability Office.
System: The UNT Digital Library