Anthrax Vaccine: Changes to the Manufacturing Process (open access)

Anthrax Vaccine: Changes to the Manufacturing Process

Testimony issued by the General Accounting Office with an abstract that begins "The original anthrax vaccine was developed in the 1950s and was first produced on a large scale by Merck. The BioPort Corporation in Michigan is now the sole facility in the United States capable of producing the vaccine. The Food and Drug Administration (FDA) licenses biological products and their production facilities. The manufacturer is required to comply with current good manufacturing practices, which regulate personnel, buildings, equipment, production controls, records, and other aspects of the vaccine manufacturing process. When there is a major change in the manufacturing process, the manufacturer must submit evidence to FDA showing that the change does not have any adverse effects. The manufacturer must also ensure that the quality of the product is maintained. In the case of the anthrax vaccine, the Michigan facility did not notify FDA of several changes to the manufacturing process in the early 1990s, and no specific studies were done to confirm that vaccine quality was not affected. FDA inspections found several deficiencies, many of which were not corrected in a timely manner."
Date: October 23, 2001
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Prescription Drugs: State and Federal Oversight of Drug Compounding by Pharmacies (open access)

Prescription Drugs: State and Federal Oversight of Drug Compounding by Pharmacies

Testimony issued by the General Accounting Office with an abstract that begins "Drug compounding--the process of mixing, combining, or altering ingredients--is an important part of the practice of pharmacy because there is a need for medications tailored to individual patient needs. Several recent compounding cases that resulted in serious illness and deaths have raised concern about oversight to ensure the safety and quality of compounded drugs. These concerns have raised questions about what states--which regulate the practice of pharmacy--and the Food and Drug Administration (FDA) are doing to oversee drug compounding. GAO was asked to examine (1) the actions taken or proposed by states and national pharmacy organizations that may affect state oversight of drug compounding, and (2) federal authority and enforcement power regarding compounded drugs. This testimony is based on discussions with the National Association of Boards of Pharmacy (NABP) and a GAO review of four states: Missouri, North Carolina, Vermont, and Wyoming. GAO also interviewed and reviewed documents from pharmacist organizations, FDA, and others involved in the practice of pharmacy or drug compounding."
Date: October 23, 2003
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Business-Owned Life Insurance: Preliminary Observations on Uses, Prevalence, and Regulatory Oversight (open access)

Business-Owned Life Insurance: Preliminary Observations on Uses, Prevalence, and Regulatory Oversight

Testimony issued by the General Accounting Office with an abstract that begins "Business-owned life insurance is held by employers on the lives of their employees, and the employer is the beneficiary of these policies. Unless prohibited by state law, businesses can retain ownership of these policies regardless of whether the employment relationship has ended. Generally, business-owned life insurance is permanent, lasting for the life of the employee and accumulating cash value as it provides coverage. Attractive features of business-owned life insurance, which are common to all permanent life insurance, generally include both tax-free accumulation of earnings on the policies' cash value and tax-free receipt of the death benefit. To address concerns that businesses were abusing their ability to deduct interest expenses on loans taken against the value of their policies, Congress passed legislation to limit this practice, and the Internal Revenue Service (IRS) and Department of Justice pursued litigation against some businesses. But concerns have remained regarding employers' ability to benefit from insuring their employees' lives. This testimony provides some preliminary information from ongoing GAO work on (1) the uses and prevalence of business-owned life insurance and (2) federal and state regulatory requirements for and oversight of business-owned life insurance."
Date: October 23, 2003
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Project Bioshield: Actions Needed to Avoid Repeating Past Mistakes (open access)

Project Bioshield: Actions Needed to Avoid Repeating Past Mistakes

Testimony issued by the Government Accountability Office with an abstract that begins "The anthrax attacks in September and October 2001 highlighted the need to develop medical countermeasures. The Project BioShield Act of 2004 authorized the Department of Health and Human Services (HHS) to procure countermeasures for a Strategic National Stockpile. However, in December 2006, HHS terminated the contract for a recombinant protective antigen (rPA) anthrax vaccine because VaxGen failed to meet a critical contractual milestone. Also, supplies of the licensed BioThrax anthrax vaccine already in the stockpile will start expiring in 2008. GAO was asked to testify on its report on Project BioShield, which is being released today. This testimony summarizes (1) factors contributing to the failure of the rPA vaccine contract and (2) issues associated with using the BioThrax in the stockpile. GAO interviewed agency and industry officials, reviewed documents, and consulted with biodefense experts."
Date: October 23, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Women in Management: Analysis of Selected Data From the Current Population Survey (open access)

Women in Management: Analysis of Selected Data From the Current Population Survey

A letter report issued by the General Accounting Office with an abstract that begins "GAO analyzed data from the Department of Labor's Current Population Survey (CPS) to better understand the challenges that women face in advancing their careers. Female managers in most of the industries GAO examined had less education, were younger, were more likely to work part-time, and were less likely to be married than were male managers. There was no statistically significant difference between the percent of management positions filled by women and the percent of all positions filled by women for five of the 10 industries GAO examined. In addition, in 1995 and 2000, full-time female managers earned less than full-time male managers, after controlling for education, age, marital status and race."
Date: October 23, 2001
Creator: United States. General Accounting Office.
Object Type: Report
System: The UNT Digital Library
Internet Infrastructure: Challenges in Developing a Public/Private Recovery Plan (open access)

Internet Infrastructure: Challenges in Developing a Public/Private Recovery Plan

Testimony issued by the Government Accountability Office with an abstract that begins "Since the early 1990s, growth in the use of the Internet has revolutionized the way that our nation communicates and conducts business. While the Internet originated as a U.S. government-sponsored research project, the vast majority of its infrastructure is currently owned and operated by the private sector. Federal policy recognizes the need to prepare for debilitating Internet disruptions and tasks the Department of Homeland Security (DHS) with developing an integrated public/private plan for Internet recovery. GAO was asked to summarize its report on plans for recovering the Internet in case of a major disruption (GAO-06-672) and to provide an update on DHS's efforts to implement that report's recommendations. The report (1) identifies examples of major disruptions to the Internet, (2) identifies the primary laws and regulations governing recovery of the Internet in the event of a major disruption, (3) evaluates DHS plans for facilitating recovery from Internet disruptions, and (4) assesses challenges to such efforts."
Date: October 23, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
U.S. Postal Service: Clear Communication with Employees Needed before Reopening the Brentwood Facility (open access)

U.S. Postal Service: Clear Communication with Employees Needed before Reopening the Brentwood Facility

Testimony issued by the General Accounting Office with an abstract that begins "On October 21, 2001, the U.S. Postal Service closed its Brentwood mail processing facility after the Centers for Disease Control and Prevention (CDC) confirmed that an employee there had contracted inhalation anthrax, an often-fatal form of the disease. On October 21 and 22, two other Brentwood employees died of inhalation anthrax. The contamination was linked to a letter that passed through the facility on or about October 12, before being opened in the office of Senator Daschle in the Hart Senate Office Building on October 15. The Hart Building was closed the next day. The Brentwood facility has since been decontaminated and will soon reopen. This testimony, which is based on ongoing work, provides GAO's preliminary observations on the decisions made in closing the facility and problems experienced in communicating with employees, as well as lessons learned from the experience."
Date: October 23, 2003
Creator: United States. General Accounting Office.
Object Type: Text
System: The UNT Digital Library
Freight Railroads: Updated Information on Rates and Other Industry Trends (open access)

Freight Railroads: Updated Information on Rates and Other Industry Trends

Testimony issued by the Government Accountability Office with an abstract that begins "The Staggers Rail Act of 1980 largely deregulated the freight railroad industry, encouraging greater reliance on competition to set rates. The act recognized the need for railroads to recover costs by setting higher rates for shippers with fewer transportation alternatives but also recognized that some shippers might be subject to unreasonably high rates. It established a threshold for rate relief and granted the Interstate Commerce Commission and the Surface Transportation Board (STB) the authority to develop a rate relief process for "captive" shippers. Since 1980 GAO has issued several reports on the freight railroad industry and issued the most recent report in October 2006 and, at the request of this Subcommittee, issued an updated report in August 2007. This statement is based on these recent reports and discusses (1) recent changes that have occurred in railroad rates and how those changes compare to changes in rail rates since 1985, (2) the extent of captivity in the industry and STB's efforts to protect captive shippers, and (3) STB's actions to address GAO's recent recommendations."
Date: October 23, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Geostationary Operational Environmental Satellites: Further Actions Needed to Effectively Manage Risks (open access)

Geostationary Operational Environmental Satellites: Further Actions Needed to Effectively Manage Risks

Testimony issued by the Government Accountability Office with an abstract that begins "The National Oceanic and Atmospheric Administration (NOAA), with the aid of the National Aeronautics and Space Administration (NASA), plans to procure the next generation of geostationary operational environmental satellites, called the Geostationary Operational Environmental Satellites-R series (GOES-R). This new series is considered critical to the United States' ability to maintain the continuity of data required for weather forecasting through the year 2028. GAO was asked to summarize its report on the GOES-R series. This report (1) assesses the status and revised plans for the GOES-R procurement and (2) evaluates whether NOAA is adequately mitigating key technical and programmatic risks facing the program. To conduct this review, GAO analyzed contractor and program data and interviewed officials from NOAA and NASA."
Date: October 23, 2007
Creator: United States. Government Accountability Office.
Object Type: Text
System: The UNT Digital Library
Project Bioshield: Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine (open access)

Project Bioshield: Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine

A letter report issued by the Government Accountability Office with an abstract that begins "The anthrax attacks in September and October 2001 highlighted the need to develop medical countermeasures. The Project BioShield Act of 2004 authorized the Department of Health and Human Services (HHS) to procure countermeasures for a Strategic National Stockpile. However, in December 2006, HHS terminated the contract for a recombinant protective antigen (rPA) anthrax vaccine because VaxGen failed to meet a critical contractual milestone. Also, supplies of the licensed BioThrax anthrax vaccine already in the stockpile will start expiring in 2008. GAO was asked to identify (1) factors contributing to the failure of the rPA vaccine contract and (2) issues associated with using the BioThrax in the stockpile. GAO interviewed agency and industry officials, reviewed documents, and consulted with biodefense experts."
Date: October 23, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Nuclear Safety: Department of Energy Needs to Strengthen Its Independent Oversight of Nuclear Facilities and Operations (open access)

Nuclear Safety: Department of Energy Needs to Strengthen Its Independent Oversight of Nuclear Facilities and Operations

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Energy (DOE) oversees contractors that operate more than 200 "high-hazard" nuclear facilities, where an accident could have serious consequences for workers and the public. DOE is charged with regulating the safety of these facilities. A key part of DOE's self-regulation is the Office of Health, Safety and Security (HSS), which develops, oversees, and helps enforce nuclear safety policies. This is the only DOE safety office intended to be independent of the program offices, which carry out mission responsibilities. This report examines (1) the extent to which HSS meets GAO's elements of effective independent nuclear safety oversight and (2) the factors contributing to any identified shortcomings with respect to these elements. GAO reviewed relevant DOE policies, interviewed officials and outside safety experts, and surveyed DOE sites to determine the number and status of nuclear facilities. GAO also assessed oversight practices against the criteria for independent oversight GAO developed based on a series of reports on DOE nuclear safety and discussions with nuclear safety experts."
Date: October 23, 2008
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Centers for Medicare and Medicaid Services: Deficiencies in Contract Management Internal Control Are Pervasive (open access)

Centers for Medicare and Medicaid Services: Deficiencies in Contract Management Internal Control Are Pervasive

A letter report issued by the Government Accountability Office with an abstract that begins "As a result of internal control deficiencies discussed in GAO's 2007 report on certain contracts at the Centers for Medicare and Medicaid Services (CMS), GAO was asked to identify the extent to which CMS (1) implemented effective control procedures over contract actions, and (2) established a strong control environment for contract management. GAO used a statistical random sample of 2008 CMS contract actions (including contract awards and modifications) to assess CMS internal control procedures. The results were projected to the population of 2008 CMS contract actions. GAO also determined the extent to which CMS implemented recommendations GAO made in 2007 to improve internal control over contracting and payments to contractors. GAO reviewed contract file documentation and interviewed senior acquisition management officials."
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Defense Critical Infrastructure: Actions Needed to Improve the Identification and Management of Electrical Power Risks and Vulnerabilities to DOD Critical Assets (open access)

Defense Critical Infrastructure: Actions Needed to Improve the Identification and Management of Electrical Power Risks and Vulnerabilities to DOD Critical Assets

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Defense (DOD) relies on a global network of defense critical infrastructure so essential that the incapacitation, exploitation, or destruction of an asset within this network could severely affect DOD's ability to deploy, support, and sustain its forces and operations worldwide and to implement its core missions, including those in Iraq and Afghanistan as well as its homeland defense and strategic missions. In October 2008, DOD identified its 34 most critical assets in this network--assets of such extraordinary importance to DOD operations that according to DOD, their incapacitation or destruction would have a very serious, debilitating effect on the ability of the department to fulfill its missions. Located both within the United States and abroad, DOD's most critical assets include both DOD- and non-DOD-owned assets. DOD relies overwhelmingly on commercial electrical power grids for secure, uninterrupted electrical power supplies to support its critical assets. DOD is the single largest consumer of energy in the United States, as we have noted in previous work. According to a 2008 report by the Defense Science Board Task Force on DOD's Energy Strategy, DOD has traditionally assumed that …
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Homeland Security: Greater Attention to Key Practices Would Improve the Federal Protective Service's Approach to Facility Protection (open access)

Homeland Security: Greater Attention to Key Practices Would Improve the Federal Protective Service's Approach to Facility Protection

A letter report issued by the Government Accountability Office with an abstract that begins "There is ongoing concern about the security of federal buildings and their occupants. The Federal Protective Service (FPS) within the Department of Homeland Security (DHS) is responsible for providing law enforcement and related security services for nearly 9,000 federal buildings under the control and custody of the General Services Administration (GSA). In 2004, GAO identified a set of key protection practices from the collective practices of federal agencies and the private sector that included: allocating resources using risk management, leveraging technology, and information sharing and coordination. As requested, GAO determined whether FPS's security efforts for GSA buildings reflected key practices. To meet this objective, GAO used its key practices as criteria, visited five sites to gain firsthand knowledge, analyzed pertinent DHS and GSA documents, and interviewed DHS, GSA, and tenant agency officials."
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Nuclear Weapons: National Nuclear Security Administration Needs to Better Manage Risks Associated with Modernization of Its Kansas City Plant (open access)

Nuclear Weapons: National Nuclear Security Administration Needs to Better Manage Risks Associated with Modernization of Its Kansas City Plant

A letter report issued by the Government Accountability Office with an abstract that begins "Built in 1943, the Kansas City Plant (KCP)--the National Nuclear Security Administration's (NNSA) primary production plant for manufacturing nonnuclear components of nuclear warheads and bombs--is to be modernized because of its age and the high cost of maintenance and operation. Among other changes, NNSA plans to relocate KCP to a new facility and increase components obtained from external suppliers from about 54 to 70 percent. KCP's continued supply of these components is essential for maintaining a reliable nuclear weapons stockpile. GAO was asked to determine (1) how KCP developed plans for modernization, (2) actions KCP has taken to ensure uninterrupted production of components, and (3) actions KCP has taken to address the risks of outsourcing. GAO reviewed planning documents and met with officials from NNSA, KCP, and Sandia National Laboratories, which designs many of the components produced at KCP."
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
U.S. Department of Justice: Information on Employment Litigation, Housing and Civil Enforcement, Voting, and Special Litigation Sections' Enforcement Efforts from Fiscal Years 2001 through 2007 (open access)

U.S. Department of Justice: Information on Employment Litigation, Housing and Civil Enforcement, Voting, and Special Litigation Sections' Enforcement Efforts from Fiscal Years 2001 through 2007

A letter report issued by the Government Accountability Office with an abstract that begins "The Civil Rights Division (Division) of the Department of Justice (DOJ) is the primary federal entity charged with enforcing federal statutes prohibiting discrimination on the basis of race, sex, disability, religion, and national origin. GAO was asked to review the Division's enforcement efforts. This report addresses the activities the Division undertook from fiscal years 2001 through 2007 to implement its enforcement responsibilities through four of its sections (1) Employment Litigation, (2) Housing and Civil Enforcement, (3) Voting, and (4) Special Litigation. To conduct our review, GAO analyzed data on cases filed in court and matters (e.g., a referral or allegation of discrimination) investigated. To supplement this analysis, GAO also reviewed a sample of closed matter files (about 210 of 5,400). GAO randomly selected matters investigated under different statutes for each section and considered the government role (e.g., plaintiff or defendant) and type of issues investigated (e.g., the nature of the alleged discrimination or violation) to ensure that the sample reflected the breadth of the work and practices of each section. While not representative of all closed matters, the sample results provided examples of why matters were …
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Service-Disabled Veteran-Owned Small Business Program: Case Studies Show Fraud and Abuse Allowed Ineligible Firms to Obtain Millions of Dollars in Contracts (open access)

Service-Disabled Veteran-Owned Small Business Program: Case Studies Show Fraud and Abuse Allowed Ineligible Firms to Obtain Millions of Dollars in Contracts

A letter report issued by the Government Accountability Office with an abstract that begins "The Service-Disabled Veteran-Owned Small Business (SDVOSB) program is intended to provide federal contracting opportunities to qualified firms. In fiscal year 2007, the Small Business Administration (SBA) reported $4 billion in governmentwide sole source and set aside SDVOSB contract awards. Given the amount of federal contract dollars being awarded to SDVOSB firms, GAO was asked to determine (1) whether cases of fraud and abuse exist within the SDVOSB program, and (2) whether the program has effective fraud-prevention controls in place. To identify whether cases exist, GAO reviewed SDVOSB contract awards and protests since 2003, and complaints sent to our fraud hotline. GAO defined a case as one or more affiliated firms who were awarded one or more SDVOSB contracts. To assess fraud-prevention controls, GAO reviewed laws and regulations and conducted interviews with SBA and Department of Veterans Affairs (VA) officials. GAO did not attempt to project the extent of fraud and abuse in the program."
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Retirement Savings: Automatic Enrollment Shows Promise for Some Workers, but Proposals to Broaden Retirement Savings for Other Workers Could Face Challenges (open access)

Retirement Savings: Automatic Enrollment Shows Promise for Some Workers, but Proposals to Broaden Retirement Savings for Other Workers Could Face Challenges

A letter report issued by the Government Accountability Office with an abstract that begins "Although employer-sponsored retirement plans can be an important component of income security after retirement, only about half of all workers participate in such plans. To foster greater participation among workers who have access to such plans, Congress included provisions that facilitate plan sponsors' adoption of automatic enrollment policies in the Pension Protection Act of 2006. To foster greater retirement savings among workers who do not have access to an employer-sponsored plan, proposals have been made at the federal level for an "automatic IRA" and at the state level for state-based programs. Because of questions about the extent of retirement savings and prospects for a sound retirement for all Americans, GAO was asked to determine (1) what is known about the effect of automatic enrollment policies among the nation's 401(k) plans, and the extent of and future prospect for such policies; and (2) the potential benefits and limitations of automatic IRA proposals and state-assisted retirement savings proposals. To answer these questions, GAO reviewed available reports and data, and interviewed plan sponsors, industry groups, investment professionals, and relevant federal agencies."
Date: October 23, 2009
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library
Geostationary Operational Environmental Satellites: Progress Has Been Made, but Improvements Are Needed to Effectively Manage Risks (open access)

Geostationary Operational Environmental Satellites: Progress Has Been Made, but Improvements Are Needed to Effectively Manage Risks

A letter report issued by the Government Accountability Office with an abstract that begins "The Department of Commerce's National Oceanic and Atmospheric Administration (NOAA), with the aid of the National Aeronautics and Space Administration (NASA), plans to procure the next generation of geostationary operational environmental satellites, called the Geostationary Operational Environmental Satellites-R series (GOES-R). This series is considered critical to the United States' ability to maintain the continuity of data required for weather forecasting through the year 2028. GAO was asked to (1) assess the status and plans for GOES-R, and (2) evaluate whether NOAA is adequately mitigating key technical and programmatic risks. To do so, GAO analyzed contractor and program data and interviewed officials from NOAA and NASA."
Date: October 23, 2007
Creator: United States. Government Accountability Office.
Object Type: Report
System: The UNT Digital Library