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A Cost-Benefit Approach for Describing and Processing Digital Objects
This presentation discusses the costs and benefits associated with creating the metadata and ensuring metadata quality in The Portal to Texas History.
Date:
August 30, 2008
Creator:
Belden, Dreanna
Object Type:
Presentation
System:
The UNT Digital Library
Recent Actions by the Chesapeake Bay Program Are Positive Steps Toward More Effectively Guiding the Restoration Effort, but Additional Steps Are Needed
Correspondence issued by the Government Accountability Office with an abstract that begins "Since 1983, the states of Maryland, Pennsylvania, and Virginia; the District of Columbia; the Chesapeake Bay Commission; and the Environmental Protection Agency (EPA) have partnered to protect and restore the deteriorated Chesapeake Bay ecosystem. The partners established the Chesapeake Bay Program (Bay Program) to manage and coordinate a variety of restoration activities and in their most recent agreement, Chesapeake 2000, which was signed in June 2000, they established 102 commitments for the Chesapeake Bay, which were organized under five broad restoration goals to be achieved by 2010. In October 2005, we issued a report in which we reviewed the management, coordination, and reporting mechanisms used by the Bay Program. Our review found that the Bay Program had (1) developed more than 100 measures of restoration but lacked an integrated approach for measuring the progress being made in restoring the bay, (2) reported on individual species and pollutants but lacked independent and credible mechanisms to report on overall bay health, and (3) developed numerous plans for accomplishing its restoration commitments but lacked a comprehensive strategy that could provide a roadmap for accomplishing the goals outlined in Chesapeake 2000, and …
Date:
August 28, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Defined Benefit Pension Plans: Guidance Needed to Better Inform Plans of the Challenges and Risks of Investing in Hedge Funds and Private Equity
A letter report issued by the Government Accountability Office with an abstract that begins "Millions of retired Americans rely on defined benefit pension plans for their financial well-being. Recent reports have noted that some plans are investing in 'alternative' investments such as hedge funds and private equity funds. This has raised concerns, given that these two types of investments have qualified for exemptions from federal regulations, and could present more risk to retirement assets than traditional investments. To better understand this trend and its implications, GAO was asked to examine (1) the extent to which plans invest in hedge funds and private equity; (2) the potential benefits and challenges of hedge fund investments; (3) the potential benefits and challenges of private equity investments; and (4) what mechanisms regulate and monitor pension plan investments in hedge funds and private equity. To answer these questions GAO interviewed relevant federal agencies, public and private pension plans, industry groups and investment professionals, and analyzed available survey data."
Date:
August 14, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Supply Chain Security: CBP Works with International Entities to Promote Global Customs Security Standards and Initiatives, but Challenges Remain
A letter report issued by the Government Accountability Office with an abstract that begins "Oceangoing cargo containers play a vital role in global trade but can also pose a risk of terrorist exploitation. U.S. Customs and Border Protection (CBP), part of the Department of Homeland Security (DHS), oversees security of the supply chain--the flow of goods from manufacturer to retailer. CBP anticipates that adoption of uniform, international customs security standards could eventually lead to a system of mutual recognition whereby the customs security-related practices and programs taken by one customs administration are recognized and accepted by another administration. In response to congressional requesters, GAO determined (1) actions CBP has taken to develop and implement international supply chain security standards, (2) actions CBP has taken with international partners to achieve mutual recognition of customs security practices, and (3) issues CBP and foreign customs administrations anticipate in implementing 100 percent scanning of U.S.-bound container cargo. To conduct its work, GAO analyzed CBP documents on supply chain security programs and international cooperation initiatives and met with CBP officials and foreign customs officials from various trading partner nations. Also, GAO drew upon its related reports and testimony on supply chain security issued earlier this …
Date:
August 15, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
DOD Business Transformation: Air Force's Current Approach Increases Risk That Asset Visibility Goals and Transformation Priorities Will Not Be Achieved
A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Defense (DOD) established a goal to achieve total asset visibility over 30 years ago. This initiative aims to provide timely, accurate information on the location, movement, status, and identity of equipment and supplies. To date, the effort has been unsuccessful. GAO was requested to determine (1) the implementation status of the Air Force's business system initiatives to achieve total asset visibility, and whether the Air Force has implemented related best practices, and (2) whether the Air Force's business transformation efforts to achieve total asset visibility are aligned within the Air Force and with DOD's broader business transformation priorities. GAO interviewed Air Force officials and reviewed Air Force documentation to obtain an understanding of the Air Force's system initiatives and strategy for achieving total asset visibility and to identify areas for improvement."
Date:
August 8, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
International Marriage Broker Regulation Act of 2005: Agencies Have Implemented Some, but Not All of the Act's Requirements
A letter report issued by the Government Accountability Office with an abstract that begins "The International Marriage Broker Regulation Act of 2005 (IMBRA) was enacted to address issues of domestic violence and abuse against noncitizens (beneficiaries) married or engaged to U.S. citizens (petitioners) who have petitioned for them to immigrate to the U.S., including those who met through an international marriage broker (IMB). IMBRA mandated that GAO study the act's impact on the visa process for noncitizen spouses and fiance(e)s. This report addresses the extent to which the U.S. Citizenship and Immigration Services (USCIS), a component of the Department of Homeland Security (DHS); the Department of State (DOS); and the Department of Justice (DOJ) have implemented IMBRA, and the extent to which USCIS and DOS have collected and maintained data for this GAO report as required by IMBRA. To address these objectives, GAO reviewed the act and related legislation, analyzed IMBRA implementation guidance and available data on applications filed, and interviewed officials at USCIS, DOS, and DOJ."
Date:
August 8, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Chemical Safety Board: Improvements in Management and Oversight Are Needed
Correspondence issued by the Government Accountability Office with an abstract that begins "The principal role of the Chemical Safety and Hazard Investigation Board (CSB) is to investigate accidental releases of regulated or extremely hazardous substances to determine the conditions and circumstances that led to the accident and to identify the cause or causes so that similar accidents might be prevented. Accidental releases of these toxic and hazardous chemicals occur frequently and often have serious consequences. CSB reported to Congress that the agency received notification of approximately 900 chemical accidents in calendar year 2007, and that 31 of these accidents were serious or even fatal events that warranted the commitment of CSB investigators. CSB began operating in 1998 as an independent agency created under the Clean Air Act Amendments of 1990. The act directs CSB to (1) investigate and report on the cause or probable cause of any accidental chemical releases from stationary sources resulting in a fatality, serious injury, or substantial property damages; (2) make recommendations to reduce the likelihood or consequences of accidental chemical releases and propose corrective measures; and (3) establish regulations for reporting accidental releases. The agency publishes investigative reports and issues safety studies and videos to …
Date:
August 22, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Defense Critical Infrastructure: Adherence to Guidance Would Improve DOD's Approach to Identifying and Assuring the Availability of Critical Transportation Assets
A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Defense (DOD) established the Defense Critical Infrastructure Program (DCIP) to assure the availability of mission-critical infrastructure, including surface, sea, and air transportation assets to carry out its missions. GAO was asked to evaluate (1) the extent to which the U.S. Transportation Command (TRANSCOM) has identified, prioritized, and assessed critical transportation assets; (2) the extent to which DOD installation personnel have taken actions to help assure the availability of critical transportation assets, both within and independent of DCIP; and (3) how DOD is funding critical transportation asset assurance. GAO examined a nonprojectable sample of 22 critical transportation assets, reviewed relevant DOD guidance and documents, and interviewed cognizant officials."
Date:
August 15, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Health Resources and Services Administration: Many Underserved Areas Lack a Health Center Site, and the Health Center Program Needs More Oversight
A letter report issued by the Government Accountability Office with an abstract that begins "Health centers funded through grants under the Health Center Program--managed by the Health Resources and Services Administration (HRSA), an agency in the U.S. Department of Health and Human Services (HHS)--provide comprehensive primary care services for the medically underserved. HRSA provides funding for training and technical assistance (TA) cooperative agreement recipients to assist grant applicants. GAO was asked to examine (1) to what extent medically underserved areas (MUA) lacked health center sites in 2006 and 2007 and (2) HRSA's oversight of training and TA cooperative agreement recipients' assistance to grant applicants and its provision of written feedback provided to unsuccessful applicants. To do this, GAO obtained and analyzed HRSA data, grant applications, and the written feedback provided to unsuccessful grant applicants and interviewed HRSA officials."
Date:
August 8, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Carbon Offsets: The U.S. Voluntary Market Is Growing, but Quality Assurance Poses Challenges for Market Participants
A letter report issued by the Government Accountability Office with an abstract that begins "Carbon offsets--reductions of greenhouse gas emissions from an activity in one place to compensate for emissions elsewhere--are a way to address climate change by paying someone else to reduce emissions. To be credible, an offset must be additional--it must reduce emissions below the quantity emitted in a business-as-usual scenario--among other criteria. Assessing credibility is inherently challenging because it is difficult to make business-as-usual projections. Outside the U.S., offsets may be purchased on compliance markets to meet requirements to reduce emissions. In the U.S., there are no federal requirements and offsets may be purchased in the voluntary market. GAO was asked to examine (1) the scope of the U.S. voluntary carbon offset market, including the role of the federal government; (2) the extent to which mechanisms for ensuring the credibility of offsets are available and used and what, if any, related information is shared with consumers; and (3) trade-offs associated with increased oversight of the U.S. market and including offsets in climate change mitigation policies. This report is based on analysis of literature and data, interviews with stakeholders, and GAO's purchase of offsets."
Date:
August 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Tax Preparers: Oregon's Regulatory Regime May Lead to Improved Federal Tax Return Accuracy and Provides a Possible Model for National Regulation
A letter report issued by the Government Accountability Office with an abstract that begins "Millions of taxpayers use paid tax return preparers and many of these paid preparers are not subject to any qualification requirements. Paid preparers in California and Oregon are exceptions in that these states have set paid preparer qualification standards. Additionally, two bills before Congress would require national paid preparer regulations. To help Congress better understand the potential costs and revenue effects of regulating paid preparers, GAO was asked to study (1) how IRS, California, Oregon, and other states regulate paid preparers, (2) how the accuracy of federal tax returns from California and Oregon compare to other returns, and (3) state-level costs and benefits of the California and Oregon programs and insights they provide for a possible national program. GAO analyzed IRS research data on tax return accuracy; interviewed IRS officials, state administrators, and preparer community representatives; and reviewed relevant documents."
Date:
August 15, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Commonwealth of the Northern Mariana Islands: Managing Potential Economic Impact of Applying U.S. Immigration Law Requires Coordinated Federal Decisions and Additional Data
A letter report issued by the Government Accountability Office with an abstract that begins "The United States enacted legislation in May 2008 applying federal immigration law to the Commonwealth of the Northern Mariana Islands (CNMI) subject to a transition period. The CNMI is subject to most U.S. laws but has administered its own immigration system, including admitting foreign workers, tourists, and foreign investors. The Secretary of Homeland Security, in consultation with the Secretaries of the Interior, Labor, and State, and the Attorney General, has the responsibility to establish a transition program. GAO was asked to review how the legislation's implementation may affect the CNMI economy, in particular the CNMI's (1) labor market, including foreign workers; (2) tourism sector; and (3) foreign investment. This report is based on GAO's March 2008 report (GAO-08-466) and analysis of data on the CNMI's labor market, tourism sector, and foreign investment."
Date:
August 4, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Individual Retirement Accounts: Additional IRS Actions Could Help Taxpayers Facing Challenges in Complying with Key Tax Rules
A letter report issued by the Government Accountability Office with an abstract that begins "Individual retirement accounts (IRA) allow individuals to save for retirement in a tax-preferred way. Traditional IRA contributions, subject to certain limitations, can be deducted from taxable earnings and taxes on earnings are deferred until distribution. In contrast, Roth IRA contributions are made after tax and distributions are tax-free. Faced with a myriad of rules covering IRA contributions and distributions, taxpayers may fail to comply with the rules. GAO was asked to (1) provide an overview of key rules and describe how the Internal Revenue Service (IRS) educates taxpayers about these rules, (2) describe what IRS knows about the extent of noncompliance with IRA transactions reported on taxpayer returns, and (3) describe challenges taxpayers face with key rules and some options for strengthening compliance. GAO reviewed IRS documents and compliance data. To identify challenges, GAO interviewed officials from the financial industry and advisor representatives."
Date:
August 14, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
DOD Business Systems Modernization: Key Navy Programs' Compliance with DOD's Federated Business Enterprise Architecture Needs to Be Adequately Demonstrated
A letter report issued by the Government Accountability Office with an abstract that begins "For decades, the Department of Defense (DOD) has been challenged in modernizing its thousands of business systems. Since 1995, GAO has designated the department's business systems modernization efforts as high risk. One key to effectively modernizing DOD's systems environment and satisfying relevant legislative requirements is ensuring that business system investments comply with an enterprisewide strategic blueprint, commonly called an enterprise architecture. For DOD's business systems modernization, it is developing and using a federated Business Enterprise Architecture (BEA), which is a coherent family of parent and subsidiary architectures. GAO was requested to determine whether key Department of the Navy business systems modernization programs comply with DOD's federated BEA. To determine this, GAO examined the BEA compliance assessments, certifications, and approvals for selected Navy programs against relevant guidance."
Date:
August 7, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Defense Acquisitions: Department of Defense Needs Framework for Balancing Investments in Tactical Radios
A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Defense (DOD) has spent an estimated $12 billion on the development and production of tactical radios over the last 5 years--about as much as was spent producing Virginia Class submarines ($10.8 billion) in the same period. Survivability and lethality in warfare are increasingly dependent on superior information and communication capabilities. DOD is counting on the Joint Tactical Radio System (JTRS) to deliver the breakthroughs in this area. At the same time as it is developing JTRS, DOD wants to ensure that current forces are equipped with sufficient legacy radios. To address Subcommittee concerns regarding DOD's approach to meeting current and future radio needs, GAO examined this subject. In response, this report addresses (1) how planned investments in key tactical radio systems changed over the last 5 years, (2) why these changes occurred, and (3) the challenges ahead. To assess these topics, GAO's work included reviewing 2003 through 2007 budget requests, legacy radio procurements, and the status of the JTRS program; and interviewing officials from DOD organizations."
Date:
August 15, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Review of the Transportation Security Administration's Air Cargo Screening Exemptions Report
Correspondence issued by the Government Accountability Office with an abstract that begins "This report formally transmits the attached briefing in response to section 1602(b) of the Implementing Recommendations of the 9/11 Commission Act of 2007. The act requires the Comptroller General to provide an assessment of the methodology used by the Secretary of Homeland Security for maintaining, changing or eliminating an exemption under 49 U.S.C. 44901(i)(1). We provided the mandated reporting committees with a restricted version of this briefing in July 2008. Based on the results of our review, we are not making any recommendations for congressional consideration or agency action. All information considered Sensitive Security Information by the Transportation Security Administration has been removed from this product."
Date:
August 15, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Military Personnel: Improvements Needed to Increase Effectiveness of DOD's Programs to Promote Positive Working Relationships between Reservists and Their Employers
Correspondence issued by the Government Accountability Office with an abstract that begins "Since September 11, 2001, the Department of Defense (DOD) has relied on more than 650,000 members of the National Guard and Reserve to support operations at home and abroad. As demobilized reservists return to civilian life and their civilian employment, the difficulties some face in maintaining positive working relationships with their employers is an area of interest. Maintaining employers' continued support for their reservist employees will be critical if DOD is to retain experienced reservists in these times of longer and more frequent deployments. The employment and reemployment rights of service members as they transition between their federal duties and their civilian employment are governed by the Uniformed Services Employment and Reemployment Rights Act (USERRA) of 1994. Education of reservists and employers about USERRA is primarily conducted through DOD's office of Employer Support of the Guard and Reserve (ESGR), which serves as DOD's focal point in managing the department's relations with reservists and their civilian employers. The Military Reservists and Veteran Small Business Reauthorization and Opportunity Act of 20083 directed the Comptroller General of the United States to report to the Senate Committee on Armed Services, the Senate …
Date:
August 15, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Grants Management: Attention Needed to Address Undisbursed Balances in Expired Grant Accounts
A letter report issued by the Government Accountability Office with an abstract that begins "In 2006, the subcommittee concluded there was a need for increased accountability and transparency for unspent funds in federal programs and agencies, and requested GAO review the status of balances not drawn down by grantees by the time the grants' period of availability had ended. GAO was asked to answer these questions: (1) to what extent are there undisbursed grant balances in expired grant accounts and do they share any program characteristics?; and (2) do these expired grants share grant management challenges and how have federal agencies improved grant closeout and diminished undisbursed balances? To do this, GAO analyzed grant balance data from the largest federal grant payment system; reviewed grant management problems and corrective actions from more than 150 audit reports; and reviewed guidance from the Office of Management and Budget (OMB) and the Code of Federal Regulations."
Date:
August 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Hurricane Katrina: Continuing Debris Removal and Disposal Issues
Correspondence issued by the Government Accountability Office with an abstract that begins "In 2005, as a result of Hurricane Katrina, more than 1,600 people lost their lives and more than a million were driven from their homes on the Gulf Coast. Tens of thousands of homes in New Orleans were flooded, many requiring either demolition or gutting before reconstruction. Nearly 3 years later, the New Orleans area still faces significant debris management issues and challenges. For example, the Louisiana Department of Environmental Quality (LDEQ) stated that while the Department of Homeland Security's Federal Emergency Management Agency (FEMA) estimated in July 2008 that it had funded about 16,900 home demolitions, an estimated 6,100 homes remained to be demolished around the New Orleans area. The Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) establishes programs and processes for the federal government to provide major disaster and emergency assistance to states, local governments, tribal nations, and others. FEMA has the responsibility for administering the provisions of the Stafford Act, including approving and funding the assistance provided under it. This assistance has been provided to the Gulf Coast under the Department of Homeland Security's National Response Framework (formerly called the National …
Date:
August 25, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
Stabilizing and Rebuilding Iraq: Iraqi Revenues, Expenditures, and Surplus
A letter report issued by the Government Accountability Office with an abstract that begins "Iraq has an estimated 115 billion barrels of crude oil reserves, the third largest in the world. Oil export revenues are critical to Iraq's reconstruction, accounting for over 90 percent of the Iraqi government's revenues. In June 2008, GAO reported low 2007 spending rates by the Iraqi government for some critical sectors in the face of declining U.S. investments in these sectors. This report examines (1) Iraq's estimated revenues from 2005 through 2008, (2) Iraq's estimated expenditures from 2005 through 2008, (3) Iraq's financial deposits through 2007 and budget surpluses, (4) U.S. cumulative expenditures on stabilization and reconstruction activities in Iraq since 2003, and (5) factors affecting Iraq's efforts to accelerate spending. GAO analyzed relevant data and reviewed documents, including Central Bank of Iraq oil receipts data, International Monetary Fund's (IMF) reports, translated copies of Iraqi budget and expenditures, and U.S. agency funding data and reports. GAO also interviewed officials from the Departments of Defense (DOD), Energy, State, Treasury, and the IMF. This report contains no recommendations. Treasury agreed with the report's findings and stated that Iraq has adequate funds to make and maintain capital investments …
Date:
August 5, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Military Base Realignments and Closures: Army Is Developing Plans to Transfer Functions from Fort Monmouth, New Jersey, to Aberdeen Proving Ground, Maryland, but Challenges Remain
Correspondence issued by the Government Accountability Office with an abstract that begins "In September 2005, the Defense Base Closure and Realignment Commission recommended that the Department of Defense (DOD) close Fort Monmouth, New Jersey, and realign most of its technical functions to Aberdeen Proving Ground, Maryland, as one of 182 recommendations in the 2005 base realignment and closure (BRAC) round. DOD must complete the closure and realignment actions specified in the recommendation within the statutory 6-year implementation period ending September 15, 2011. Representatives from communities surrounding Fort Monmouth, as well as elected officials, raised concerns during hearings before the BRAC Commission that a number of current employees would not move to Aberdeen Proving Ground, leading to a loss of expertise that could negatively affect ongoing support for military operations, including the Global War on Terrorism. The Secretary of the Army pledged that the Army would not allow the transfer of functions to Aberdeen Proving Ground to affect this ongoing support. Although some of the BRAC commissioners shared the concern about the potential loss of expertise, the commission concluded in its report that DOD could mitigate the adverse effects of moving existing programs over the implementation period. However, to ensure that …
Date:
August 13, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Text
System:
The UNT Digital Library
U.S. Multinational Corporations: Effective Tax Rates Are Correlated with Where Income Is Reported
A letter report issued by the Government Accountability Office with an abstract that begins "U.S. and foreign tax regimes influence decisions of U.S. multinational corporations (MNC) regarding how much to invest and how many workers to employ in particular activities and in particular locations. Tax rules also influence where corporations report earning income for tax purposes. The average effective tax rate, which equals the amount of income taxes a business pays divided by its pretax net income (measured according to accounting rules, not tax rules), is a useful measure of actual tax burdens. In response to a request from U.S. Senate Committee on Finance, this report provides information on the average effective tax rates that U.S.-based businesses pay on their domestic and foreign-source income and trends in the location of worldwide activity of U.S.-based businesses. GAO analyzed Internal Revenue Service (IRS) data on corporate taxpayers, including new data for 2004 and Bureau of Economic Analysis data on the domestic and foreign operations of U.S. MNCs. Data limitations are noted where relevant. GAO is not making any recommendations in this report."
Date:
August 12, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Military Personnel: DOD's and the Coast Guard's Sexual Assault Prevention and Response Programs Face Implementation and Oversight Challenges
A letter report issued by the Government Accountability Office with an abstract that begins "In 2004, Congress directed the Department of Defense (DOD) to establish a comprehensive policy to prevent and respond to sexual assaults involving servicemembers. Though not required to do so, the Coast Guard has established a similar policy. In response to congressional requests and Senate Report No. 110-77, GAO evaluated the extent to which DOD and the Coast Guard (1) have developed and implemented policies and programs to prevent, respond to, and resolve sexual assault incidents involving servicemembers; (2) have visibility over reports of sexual assault involving servicemembers; and (3) exercise oversight over reports of sexual assault involving servicemembers. To conduct this review, GAO reviewed legislative requirements and DOD and Coast Guard guidance; analyzed sexual assault incident data; and obtained through surveys and interviews the perspective on sexual assault matters of more than 3,900 servicemembers."
Date:
August 29, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library
Food and Drug Administration: Approval and Oversight of the Drug Mifeprex
A letter report issued by the Government Accountability Office with an abstract that begins "In September 2000, the Food and Drug Administration (FDA), part of the Department of Health and Human Services (HHS), approved the drug Mifeprex for use in terminating early term pregnancy. FDA approved the drug under a provision of its Subpart H regulations, allowing it to restrict the drug's distribution to assure its safe use. Critics have questioned aspects of the Mifeprex approval process, including the reliance on historically-controlled clinical trials that compare a drug's effects on a condition to the known course of the condition rather than to another drug or placebo. Critics argued that Mifeprex does not fit within the scope of Subpart H, which applies to drugs that treat serious or life-threatening illnesses. Concerns have also been raised about FDA's oversight of the drug since approval, including the agency's response to deaths in U.S. women who had taken the drug. In this report GAO (1) describes FDA's approval of Mifeprex, including the evidence considered and the restrictions placed on its distribution; (2) compares the Mifeprex approval process to the approval processes for other Subpart H restricted drugs; and (3) compares FDA's postmarket oversight of …
Date:
August 7, 2008
Creator:
United States. Government Accountability Office.
Object Type:
Report
System:
The UNT Digital Library