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Federal Rulemaking: The Role of the Office of Information and Regulatory Affairs (open access)

Federal Rulemaking: The Role of the Office of Information and Regulatory Affairs

This report discusses the Paperwork Reduction Act of 1980, which created the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB). This report addresses OIRA's responsibilities, controversies related to OIRA, and possible legislative issues involving OIRA, including increasing or decreasing the office's funding and staffing, and improvements in the transparency of OIRA's review process.
Date: June 9, 2009
Creator: Copeland, Curtis W.
Object Type: Report
System: The UNT Digital Library
The Worker Adjustment and Retraining Notification Act (WARN) (open access)

The Worker Adjustment and Retraining Notification Act (WARN)

Congress has passed legislation to facilitate the reemployment of workers who through no fault of their own are let go by their employers. Among these laws is the Worker Adjustment and Retraining Notification (WARN) Act, P.L. 100-379, enacted in 1988. This report discusses the WARN Act in brief, especially as related to Congress's renewed interest in the Act due to the current financial crises and recession.
Date: July 9, 2009
Creator: Levine, Linda
Object Type: Report
System: The UNT Digital Library
Surface Coal Mining: Characteristics of Mining in Mountainous Areas of Kentucky and West Virginia (open access)

Surface Coal Mining: Characteristics of Mining in Mountainous Areas of Kentucky and West Virginia

A letter report issued by the Government Accountability Office with an abstract that begins "Surface coal mining in the mountainous areas of Appalachia--often called "mountaintop mining"--generates controversy, in part because of its scale and the post-mining appearance of the land. Yet there is limited public access to information on the size, location, and life span of these operations, or on how the land can be expected to look afterward. The Government Accountability Office (GAO) was asked to report on the characteristics of (1) surface coal mining and (2) reclaimed lands that were disturbed by surface coal mining in the mountainous, eastern part of Kentucky and in West Virginia, where most such mining occurs. Federal and state law requires mining operators to obtain permits before mining. Among other things, the permits identify the acres under open permit (the acres subject to mining associated with a permit that has not been closed) and how the land will be reclaimed--including the post-mining land use, whether the approximate original contour (AOC) of the land will be restored, and the extent to which excess earth, rock, and other materials (known as "spoil") are placed in nearby valleys. For this study, GAO relied on electronic databases …
Date: December 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Affordable Housing in Transit-Oriented Development: Key Practices Could Enhance Recent Collaboration Efforts between DOT-FTA and HUD (open access)

Affordable Housing in Transit-Oriented Development: Key Practices Could Enhance Recent Collaboration Efforts between DOT-FTA and HUD

A letter report issued by the Government Accountability Office with an abstract that begins "The federal government has increasingly focused on linking affordable housing to transit-oriented developments--compact, walkable, mixed-use neighborhoods located near transit--through the Department of Housing and Urban Development's (HUD) housing programs and the Department of Transportation's (DOT) Federal Transit Administration's (FTA) transit programs. GAO was asked to review (1) what is known about how transit-oriented developments affect the availability of affordable housing; (2) how local, state, and federal agencies have worked to ensure that affordable housing is available in transit-oriented developments; and (3) the extent to which HUD and FTA have worked together to ensure that transportation and affordable housing objectives are integrated in transit-oriented developments. To address these issues, GAO reviewed relevant literature, conducted site visits, and interviewed agency officials."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Social Security Administration: Service Delivery Plan Needed to Address Baby Boom Retirement Challenges (open access)

Social Security Administration: Service Delivery Plan Needed to Address Baby Boom Retirement Challenges

A letter report issued by the Government Accountability Office with an abstract that begins "Millions of people rely on the services of Social Security Administration (SSA) field offices. In fiscal year 2008, SSA's approximately 1,300 field offices provided service to about 44 million customers. People visit field offices to apply for Social Security cards, apply for retirement and disability benefits, establish direct deposit, and a host of other services. Over the last several years, staffing reductions have challenged field offices' ability to manage work while continuing to deliver quality customer service. To better understand the challenges SSA faces in delivering quality customer service, GAO was asked to determine (1) the effect that staffing reductions are having on field office operations and (2) the challenges SSA faces in meeting service delivery needs in the future and the agency's plan for addressing them. In May 2008, GAO reported initial observations on the effects of reduced staff levels. To conduct this work, GAO interviewed SSA headquarters and field officials and analyzed various data on SSA's workloads and customer service."
Date: January 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Defense Business Transformation: Status of Department of Defense Efforts to Develop a Management Approach to Guide Business Transformation (open access)

Defense Business Transformation: Status of Department of Defense Efforts to Develop a Management Approach to Guide Business Transformation

Correspondence issued by the Government Accountability Office with an abstract that begins "This letter formally transmits GAO's findings on the status of the Department of Defense's efforts to develop a management approach to guide business transformation. This work was performed under the authority of the Comptroller General to conduct evaluations on his own initiative and as part of our work for GAO's High Risk Series, January 2009 Update."
Date: January 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Secure Border Initiative: Technology Deployment Delays Persist and the Impact of Border Fencing Has Not Been Assessed (open access)

Secure Border Initiative: Technology Deployment Delays Persist and the Impact of Border Fencing Has Not Been Assessed

A letter report issued by the Government Accountability Office with an abstract that begins "Securing the nation's borders from illegal entry of aliens and contraband, including terrorists and weapons of mass destruction, continues to be a major challenge. In November 2005, the Department of Homeland Security (DHS) announced the launch of the Secure Border Initiative (SBI), a multiyear, multibillion dollar program aimed at securing U.S. borders and reducing illegal immigration. Within DHS, U.S. Custom and Border Protection's (CBP) SBI program is responsible for developing a comprehensive border protection system using technology, known as SBInet, and tactical infrastructure--fencing, roads, and lighting. GAO was asked to provide periodic updates on the status of the program. This report addresses (1) the extent to which CBP has implemented SBInet and the impact of delays that have occurred, and (2) the extent to which CBP has deployed tactical infrastructure and assessed its results. To do this work, GAO reviewed program schedules, status reports, and previous GAO work; interviewed DHS and CBP officials, among others; and visited three SBI sites where initial technology or fencing had been deployed at the time of GAO's review."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Social Security Disability: Improving Notices to Denied Claimants (open access)

Social Security Disability: Improving Notices to Denied Claimants

Correspondence issued by the Government Accountability Office with an abstract that begins "On December 17, 2008, GAO issued a report concerning our findings on the Social Security Administration's (SSA) collection of medical evidence in the disability determination process. In the course of our review, an issue arose that was outside the scope of our work but is important to how SSA communicates its disability determinations to claimants. During this review, we examined a limited random selection of electronic folders for initial disability determinations for fiscal year 2007. The folders included notices sent to each denied claimant to explain the reasons for the denial of their claim and the evidence used to make the determination. Our findings related to these notices and current SSA policy regarding them is the subject of this report. This report also contains a recommendation that warrants SSA management's consideration."
Date: January 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Medicaid: Fraud and Abuse Related to Controlled Substances Identified in Selected States (open access)

Medicaid: Fraud and Abuse Related to Controlled Substances Identified in Selected States

A letter report issued by the Government Accountability Office with an abstract that begins "One significant cost to Medicaid is prescription drugs, which accounted for over $23 billion in fiscal year (FY) 2008, or about 7 percent of total Medicaid outlays. Many of these drugs are susceptible to abuse and include pain relievers and stimulants that are on the Drug Enforcement Administration's (DEA) Schedule of Controlled Substances. As part of the American Recovery and Reinvestment Act of 2009 (ARRA), the Medicaid program will receive about $87 billion in federal assistance based on a greater federal share of Medicaid spending. GAO was asked to determine (1) whether there are indications of fraud and abuse related to controlled substances paid for by Medicaid; (2) if so, examples of fraudulent, improper, and abusive activity; and (3) the effectiveness of internal controls that the federal government and selected states have in place to prevent fraud and abuse related to controlled substances. To meet these objectives, GAO analyzed Medicaid controlled substance claims for fraud and abuse indications for FY 2006 and 2007 from five selected states. GAO also interviewed federal and state officials and performed investigations."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Wildland Fire Management: Federal Agencies Have Taken Important Steps Forward, but Additional, Strategic Action is Needed to Capitalize on Those Steps (open access)

Wildland Fire Management: Federal Agencies Have Taken Important Steps Forward, but Additional, Strategic Action is Needed to Capitalize on Those Steps

A letter report issued by the Government Accountability Office with an abstract that begins "The nation's wildland fire problems have worsened dramatically over the past decade, with more than a doubling of average annual acreage burned and federal appropriations for wildland fire management. The deteriorating fire situation has led the agencies responsible for managing wildland fires on federal lands--the Forest Service in the Department of Agriculture and four agencies in the Department of the Interior--to reassess how they respond to wildland fire and to take steps to improve their fire management programs. GAO reviewed (1) progress the agencies have made in managing wildland fire and (2) key actions GAO previously recommended and believes are still necessary to improve wildland fire management. GAO reviewed previous GAO reports and agency documents and interviewed agency officials. GAO prepared this report under the Comptroller General's authority to conduct evaluations on his own initiative."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
School Meal Programs: Improved Reviews, Federal Guidance, and Data Collection Needed to Address Counting and Claiming Errors (open access)

School Meal Programs: Improved Reviews, Federal Guidance, and Data Collection Needed to Address Counting and Claiming Errors

A letter report issued by the Government Accountability Office with an abstract that begins "In fiscal year 2008, the National School Lunch Program and School Breakfast Program provided meals to 30.9 million and 10.5 million children, respectively. Recently, the U.S. Department of Agriculture (USDA) issued the first estimate of improper payments due to meal counting and claiming errors in these programs, which was approximately $860 million (8.6 percent of federal program reimbursements) in school year 2005-2006. These errors include: (1) cashier errors, such as those made in determining if a meal meets the federal menu planning and nutrition requirements (meal counting), and (2) aggregation errors made when officials count and total meals for federal reimbursement (meal claiming). GAO was asked to review (1) actions taken by states and school food authorities (SFA) to identify and address meal counting and claiming errors; and (2) actions taken by USDA to help states and SFAs identify and address meal counting and claiming errors. GAO's steps included analyzing data on state administrative reviews of SFAs; surveying all states; conducting site visits; and interviewing federal, state, and SFA officials."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Transportation Security Administration: TSA Executive Attrition Has Declined, but Better Information Is Needed on Reasons for Leaving and Executive Hiring Process (open access)

Transportation Security Administration: TSA Executive Attrition Has Declined, but Better Information Is Needed on Reasons for Leaving and Executive Hiring Process

A letter report issued by the Government Accountability Office with an abstract that begins "The Transportation Security Administration's (TSA) Transportation Security Executive Service (TSES) consists of executive-level staff serving in key agency positions just below political appointees. Committees of Congress have raise questions about the frequency of turnover within the TSES and have directed GAO to examine turnover among TSES staff. Accordingly, this report examines: (1) TSES attrition and how it compares with that of Senior Executive Service (SES) staff in other DHS components and cabinet-level departments, (2) the reasons TSES staff separated from TSA, and (3) TSA efforts to mange TSES attrition consistent with effective management practices. To answer these objectives, GAO analyzed data within the Office of Personnel Management's Central Personnel Data File, reviewed TSA human capital policies and procedures, and interviewed former TSES staff. The results of these interviews are not generalizable, but represent the views of about half the TSES staff who separated from fiscal years 2005 through 2008."
Date: October 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Information Security: Continued Efforts Needed to Address Significant Weaknesses at IRS (open access)

Information Security: Continued Efforts Needed to Address Significant Weaknesses at IRS

A letter report issued by the Government Accountability Office with an abstract that begins "The Internal Revenue Service (IRS) relies extensively on computerized systems to carry out its demanding responsibilities to collect taxes (about $2.7 trillion in fiscal years 2008 and 2007), process tax returns, and enforce the nation's tax laws. Effective information security controls are essential to protect financial and taxpayer information from inadvertent or deliberate misuse, improper disclosure, or destruction. As part of its audits of IRS's fiscal years 2008 and 2007 financial statements, GAO assessed (1) the status of IRS's actions to correct previously reported weaknesses and (2) whether controls were effective in ensuring the confidentiality, integrity, and availability of financial and sensitive taxpayer information. To do this, GAO examined IRS information security policies and procedures and other documents; tested controls over key financial applications; and interviewed key agency officials."
Date: January 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Military Base Realignments and Closures: DOD Needs to Update Savings Estimates and Continue to Address Challenges in Consolidating Supply-Related Functions at Depot Maintenance Locations (open access)

Military Base Realignments and Closures: DOD Needs to Update Savings Estimates and Continue to Address Challenges in Consolidating Supply-Related Functions at Depot Maintenance Locations

A letter report issued by the Government Accountability Office with an abstract that begins "As a result of a 2005 Defense Base Realignment and Closure (BRAC) recommendation, the Defense Logistics Agency (DLA) is charged with consolidating supply, storage, and distribution functions at 13 military service depot maintenance locations to streamline operations and save money. The BRAC Commission data indicate that these consolidations would generate net savings of nearly $1 billion through 2011 and about $137 million annually thereafter. Because these actions could affect depot maintenance operations, the conference report accompanying the National Defense Authorization Act for Fiscal Year 2008 directed GAO to assess implementation issues associated with the consolidations. GAO's objectives were to assess (1) DLA's progress and challenges to implement these consolidation actions and (2) the extent to which DLA's most recent cost and savings estimates related to these consolidations differ from those of the BRAC Commission. To meet these objectives, GAO visited three depot locations where consolidation actions had begun, interviewed service and DLA officials, and analyzed estimated cost and savings data."
Date: July 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
High-Level Leadership Needed to Help Guam Address Challenges Caused by DOD-Related Growth (open access)

High-Level Leadership Needed to Help Guam Address Challenges Caused by DOD-Related Growth

Correspondence issued by the Government Accountability Office with an abstract that begins "In an effort to improve the U.S. military's flexibility to address conventional and terrorist threats worldwide, the Department of Defense (DOD) plans to relocate more than 8,000 Marines and an estimated 9,000 dependents from Okinawa, Japan, to Guam as well as expand other U.S. force capabilities on the island at an estimated cost of more than $13 billion. Guam is an integral part of DOD's logistical support system and serves as an important forward operational hub for a mix of military mission requirements. According to DOD, Guam provides strategic flexibility, freedom of action, and prompt global action for the Global War on Terrorism, peace and wartime engagement, and crisis response. DOD plans to begin construction on Guam during fiscal year 2010 in order to meet the desired buildup deadline of fiscal year 2014 indicated in the agreement reached by the U.S.-Japan Security Consultative Committee on October 29, 2005. As a result of the military buildup, Guam's current population of 171,000 will increase by an estimated 25,000 active duty military personnel and dependents (or 14.6 percent), to 196,000. In addition, the realignment will require additional workers to move to …
Date: April 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Railroad Retirement Board: Review of Commuter Railroad Occupational Disability Claims Reveals Potential Program Vulnerabilities (open access)

Railroad Retirement Board: Review of Commuter Railroad Occupational Disability Claims Reveals Potential Program Vulnerabilities

Correspondence issued by the Government Accountability Office with an abstract that begins "In fall 2008, a series of news reports revealed the relatively high number of workers at one commuter railroad--the Long Island Rail Road (LIRR)-- who have applied for and been approved for occupational disability benefits by the U.S. Railroad Retirement Board (RRB). According to RRB officials, a number of federal agencies, including the Federal Bureau of Investigation, Social Security Administration, and the Department of Health and Human Services, have launched investigations in response to issues raised. In addition, the New York Attorney General's office is conducting a criminal investigation."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Emergency Preparedness: Improved Planning and Coordination Necessary for Modernization and Integration of Public Alert and Warning System (open access)

Emergency Preparedness: Improved Planning and Coordination Necessary for Modernization and Integration of Public Alert and Warning System

A letter report issued by the Government Accountability Office with an abstract that begins "A comprehensive system to alert the American people in times of hazard allows people to take action to save lives. The Federal Emergency Management Agency (FEMA) is responsible for the current Emergency Alert System (EAS) and the development of the new Integrated Public Alert and Warning System (IPAWS). In this requested report, GAO examined (1) the current status of EAS, (2) the progress made by FEMA in implementing an integrated alert and warning system, and (3) the challenges involved in implementing an integrated alert and warning system. GAO conducted a survey of states, reviewed FEMA and other documentation, and interviewed industry stakeholders and officials from federal agencies responsible for public alerting."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Aviation Weather: FAA and the National Weather Service Are Considering Plans to Consolidate Weather Service Offices, but Face Significant Challenges (open access)

Aviation Weather: FAA and the National Weather Service Are Considering Plans to Consolidate Weather Service Offices, but Face Significant Challenges

A letter report issued by the Government Accountability Office with an abstract that begins "The National Weather Service's (NWS) weather products are a vital component of the Federal Aviation Administration's (FAA) air traffic control system. In addition to providing aviation weather products developed at its own facilities, NWS also provides on-site staff at each of FAA's en route centers--the facilities that control high-altitude flight outside the airport tower and terminal areas. Over the last few years, FAA and NWS have been exploring options for enhancing the efficiency of the aviation weather services provided at en route centers. GAO agreed to (1) determine the status and plans of efforts to restructure the center weather service units, (2) evaluate efforts to establish a baseline of the current performance provided by these units, and (3) evaluate challenges to restructuring them. To do so, GAO evaluated agency plans for the restructuring and for establishing performance measures. GAO also compared agency efforts to leading practices and interviewed agency officials."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Aviation Security: TSA's Cost and Performance Study of Private-Sector Airport Screening (open access)

Aviation Security: TSA's Cost and Performance Study of Private-Sector Airport Screening

Correspondence issued by the Government Accountability Office with an abstract that begins "This report formally responds to Congress' request that GAO review the Transportation Security Administration's (TSA) Screening Partnership Program (SPP). In accordance with the Aviation and Transportation Security Act, TSA created the SPP to allow commercial airports an opportunity to apply to TSA to use private sector screeners through qualified private-screening contractors approved by TSA. In February 2008, TSA issued a report on its study comparing the cost and performance of screening services at SPP and non-SPP airports. Our briefing addresses the following questions: (1) To what extent did the design of TSA's study of the cost and performance of passenger and checked baggage screening services at selected SPP and non-SPP airports affect the usefulness of the study? (2) To what extent has TSA taken actions to identify and eliminate any unnecessary overhead/supervisory redundancies at SPP airports between TSA and contractor personnel? (3) What factors do airport operators cite as having contributed to airports' decisions about whether to participate in the SPP? We are recommending that if TSA plans to rely on its comparison of costs and performance of SPP and non-SPP airports for future decision making, the agency …
Date: January 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Social Security Disability: Additional Performance Measures and Better Cost Estimates Could Help Improve SSA's Efforts to Eliminate Its Hearings Backlog (open access)

Social Security Disability: Additional Performance Measures and Better Cost Estimates Could Help Improve SSA's Efforts to Eliminate Its Hearings Backlog

A letter report issued by the Government Accountability Office with an abstract that begins "(SSA) has experienced processing delays and significant backlogs of disability claims at the hearings level. In May 2007, SSA began implementing a plan for eliminating the hearings backlog entitled Summary of Initiatives to Eliminate the SSA Hearings Backlog (the Plan). In response to a congressional request, GAO (1) examined the Plan's potential to eliminate the hearings-level backlog, (2) determined the extent to which the Plan included components of sound planning, and (3) identified potential unintended effects of the Plan on hearings-level operations and other aspects of the disability process. To address these objectives, GAO analyzed SSA data, conducted a risk analysis, assessed the Plan and its update--the May 2009 Draft Appomattox Plan--using planning criteria identified in previous GAO work, interviewed SSA officials, and conducted site visits in three SSA regions."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Contract Management: Agencies Are Not Maximizing Opportunities for Competition or Savings under Blanket Purchase Agreements despite Significant Increase in Usage (open access)

Contract Management: Agencies Are Not Maximizing Opportunities for Competition or Savings under Blanket Purchase Agreements despite Significant Increase in Usage

A letter report issued by the Government Accountability Office with an abstract that begins "The Federal Acquisition Regulation (FAR) allows agencies to establish blanket purchase agreements (BPA) under the General Services Administration's (GSA) Schedules Program, where contracts are awarded to multiple vendors for commercial goods and services and made available for agency use. BPAs are agreements between agencies and vendors with terms in place for future use; funds are obligated when orders are placed. When establishing BPAs under schedule contracts, agencies must follow procedures regarding the number of vendors considered, request discounts, and conduct annual reviews in accordance with requirements. This report assesses selected agencies' use of schedule BPAs and evaluates whether they considered more than one vendor when establishing BPAs and placing orders under them, took opportunities for savings, and conducted annual reviews. To conduct this work, GAO reviewed a sample of 336 schedule BPAs and 352 fiscal year 2007 orders and met with officials."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Financial Audit: Office of Financial Stability (Troubled Asset Relief Program) Fiscal Year 2009 Financial Statements (open access)

Financial Audit: Office of Financial Stability (Troubled Asset Relief Program) Fiscal Year 2009 Financial Statements

A letter report issued by the Government Accountability Office with an abstract that begins "On October 3, 2008, the Emergency Economic Stabilization Act of 2008 (EESA) was signed into law. EESA authorized the Secretary of the Treasury to implement the Troubled Asset Relief Program (TARP) and established the Office of Financial Stability (OFS) within the Department of the Treasury (Treasury) to do so. EESA requires the annual preparation of financial statements for TARP, and further requires GAO to audit these statements. GAO audited OFS's fiscal year 2009 financial statements for TARP to determine whether, in all material respects, (1) the financial statements were fairly stated, and (2) OFS management maintained effective internal control over financial reporting. GAO also tested OFS's compliance with selected provisions of laws and regulations. We will be separately reporting to OFS on additional details concerning the findings in this report along with recommendations for corrective actions. In commenting on a draft of this report, the Assistant Secretary, Office of Financial Stability, stated OFS concurred with the two significant deficiencies in its internal control over financial reporting GAO identified. He also stated that OFS is committed to correcting the deficiencies."
Date: December 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Homeland Defense: U.S. Northern Command Has a Strong Exercise Program, but Involvement of Interagency Partners and States Can Be Improved (open access)

Homeland Defense: U.S. Northern Command Has a Strong Exercise Program, but Involvement of Interagency Partners and States Can Be Improved

A letter report issued by the Government Accountability Office with an abstract that begins "U.S. Northern Command (NORTHCOM) exercises to test preparedness to perform its homeland defense and civil support missions. GAO was asked to assess the extent to which NORTHCOM is (1) consistent with Department of Defense (DOD) training and exercise requirements, (2) involving interagency partners and states in its exercises, (3) using lessons learned and corrective actions to improve preparedness, and (4) integrating its exercises with the National Exercise Program (NEP). To do this, GAO reviewed NORTHCOM and NEP guidance and postexercise documentation, assessed NORTHCOM compliance, and compared DOD and NEP exercise requirements."
Date: September 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed (open access)

Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed

A letter report issued by the Government Accountability Office with an abstract that begins "There have been long-standing concerns regarding the Food and Drug Administration's (FDA) oversight of postmarket drug safety. In 2006, GAO reported that FDA had not clearly defined the roles of two offices involved in making decisions about postmarket safety--the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE). GAO and others reported additional concerns such as limitations in the data FDA relies on to identify postmarket drug safety issues and the systems it uses to track such issues. At that time, GAO made recommendations, including that FDA improve the independence of its program for resolving scientific disputes related to postmarket drug safety. In 2007, legislation further expanded FDA's postmarket responsibilities. This report examines the steps that FDA is taking to (1) enhance its processes for making decisions about the safety of marketed drugs, (2) improve access to data that help the agency identify drug safety issues, and (3) build its capacity to fulfill its postmarket drug safety workload. GAO reviewed FDA policies and planning documents, and interviewed FDA officials."
Date: November 9, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library