Public Health Preparedness: Developing and Acquiring Medical Countermeasures Against Chemical, Biological, Radiological, and Nuclear Agents
Published: 2011-04-13T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The anthrax attacks of 2001 and a radiation leak after the recent natural disaster in Japan highlighted concerns that the United States is vulnerable to threats from chemical, biological, radiological, and nuclear (CBRN) agents, which can cause widespread illness and death. Medical countermeasures--such as drugs, vaccines, and diagnostic devices--can prevent or treat the health effects of exposure, but few are currently available for many of these CBRN agents. GAO was asked to testify on the Department of Health and Human Services' (HHS) CBRN medical countermeasure development and acquisition activities. This statement focuses on (1) how HHS determines needed CBRN medical countermeasures and priorities for development and acquisition and (2) selected challenges to medical countermeasure development and acquisition. This statement of preliminary findings is based on ongoing work. To do this work, GAO examined relevant laws and presidential directives, analyzed federal agency documents and reports from advisory boards and expert groups, and interviewed officials from HHS and the Department of Homeland Security (DHS) about the processes for developing and acquiring CBRN medical countermeasures and the challenges related to those efforts. GAO shared the information in this statement with HHS. HHS provided technical comments, which GAO incorporated as appropriate.
section_title: What GAO Found
paragraphs: HHS coordinates and leads federal efforts to determine CBRN medical countermeasure priorities and develop and acquire CBRN medical countermeasures, primarily through an interagency body that includes other federal agencies with related responsibilities, such as DHS and the Department of Defense. HHS's medical countermeasure acquisition strategy is based on a four-step process: (1) identify and assess the threat of CBRN agents, (2) assess medical and public health consequences of attacks with these agents, (3) establish medical countermeasure requirements, and (4) identify and prioritize near-, mid-, and long-term development and acquisition. Through these processes, HHS determines which countermeasures to buy for specific CBRN agents, including the desired characteristics of these countermeasures--such as how many doses a vaccine requires to confer immunity--the needed quantity of certain medical countermeasures, and the acquisition priorities. While a few CBRN countermeasures can be immediately acquired, most have not yet been developed. Therefore, HHS and the interagency body support and oversee several stages of research and development to try to obtain usable countermeasures. These include basic cellular and biological research to understand the effects of these agents on humans; applied research to validate approaches, such as testing the effectiveness of treatment in animals; early development to assess the safety of potential countermeasures; and advanced development, in which the products are more fully evaluated for safety and effectiveness, including their formulation and manufacturing processes. The federal government faces a variety of challenges in developing and acquiring medical countermeasures, such as the high failure rate in research and development and difficulties meeting regulatory requirements. For example, the failure rate for development and licensure of most drugs, vaccines, and diagnostic devices can be more than 80 percent, depending on the stage of scientific research and development. Given this risk, as well as a lack of a commercial market for most medical countermeasures, attracting large, experienced pharmaceutical firms to research and develop them is challenging. Smaller biotechnology companies are more likely to be developing medical countermeasures, but HHS must provide more guidance to these less experienced small companies than might be typical with larger companies. In addition, several challenges exist related to regulatory processes for evaluating promising medical countermeasures. These challenges include (1) proving a countermeasure's effectiveness using animals as proxies for humans, because humans cannot ethically be used in studies involving CBRN agents; (2) determining appropriate doses of countermeasures for children, who may be more vulnerable to exposure to CBRN agents; and (3) evaluating the safety and effectiveness of medical countermeasures for use in a public health emergency if they have not yet been approved or licensed. Finally, HHS faces the logistical challenge of ongoing replenishment of expiring medical countermeasures in the U.S. Strategic National Stockpile, the national repository of medications, medical supplies, and equipment for public health emergencies.

section_title: Letter
paragraphs: I am pleased to be here today to discuss the Department of Health and  Human Services’ (HHS) chemical, biological, radiological, and nuclear  (CBRN) medical countermeasure development and acquisition activities  and associated challenges. The anthrax attacks of 2001 raised concerns  that the United States is vulnerable to intentional threats from CBRN  agents. In addition, the recent earthquake and resulting tsunami in Japan  that caused a nuclear reactor to rupture highlighted a population’s  vulnerability to unintentional CBRN exposure, such as to radiation. CBRN  agents have the potential to cause widespread illness and death, which can  be partially mitigated through the use of medical countermeasures.  Medical countermeasures for CBRN agents include drugs, vaccines, and  devices to diagnose, treat, prevent, or mitigate potential effects of  exposure. Members of Congress, federal commissions, and other experts  have noted the need for the United States to acquire available medical  countermeasures and develop new ones to protect the public from attacks  with CBRN agents. While rapid diagnosis, treatment, and prevention may  minimize the public health impact of a release of these agents, there are  currently few countermeasures available for many CBRN agents, and  research and development to create usable countermeasures is a lengthy  and complex process.
You asked us to provide information about HHS’s CBRN medical  countermeasure development and acquisition activities. My statement  today addresses (1) how HHS determines needed CBRN medical  countermeasures and priorities for development and acquisition and   (2) selected challenges to federal CBRN medical countermeasure  development and acquisition.
To develop preliminary findings based on our ongoing work on HHS’s  CBRN medical countermeasure development and acquisition activities and  selected challenges of these activities, we reviewed relevant laws and  agency documents and interviewed federal officials. Specifically, to  understand how HHS determines needed CBRN medical countermeasures  and priorities for developing and acquiring them, we examined relevant  laws and reviewed presidential directives that guide HHS’s CBRN medical  countermeasure development and acquisition activities. We obtained and  analyzed HHS planning documents for medical countermeasure  development and acquisition, such as public health and medical  consequence modeling reports and strategy and implementation plans for  medical countermeasure development and acquisition priorities. We  interviewed officials from the Department of Homeland Security (DHS)  about their activities related to CBRN agents and medical  countermeasures. We also interviewed officials from HHS offices and  agencies, including the Biomedical Advanced Research and Development  Authority (BARDA) within the Office of the Assistant Secretary for  Preparedness and Response (ASPR), the Centers for Disease Control and  Prevention (CDC), the Food and Drug Administration (FDA), and the  National Institutes of Health (NIH), to obtain information on their  activities related to medical countermeasure development and acquisition.  These officials participate in the Public Health Emergency Medical  Countermeasures Enterprise (PHEMCE), HHS’s interagency decision- making body responsible for providing recommendations to the Secretary  of HHS regarding CBRN medical countermeasure development and  acquisition. To identify selected challenges that the federal government  faces in developing and acquiring CBRN medical countermeasures, we  reviewed reports from federal agencies, advisory boards, and  nongovernmental organizations and interviewed federal officials from the  agencies identified above and other experts. We included selected  challenges that were discussed in multiple reports published by federal  agencies or other expert groups, such as the Institute of Medicine, or those  mentioned to us by officials from multiple federal agencies or  organizations. We did not include any challenges that related to  interagency coordination and agency investments in medical  countermeasure development and acquisition because we are currently  examining these issues for ongoing audit work. In addition, because it was  not the focus of this hearing, we excluded HHS processes for and  challenges in distributing CBRN medical countermeasures from the scope  of this statement. We shared the information in this statement with HHS.  HHS provided technical comments, which we incorporated as appropriate.
We are conducting this performance audit in accordance with generally  accepted government auditing standards. This statement is based on work  conducted from March 2011 to April 2011. The performance audit  standards require that we plan and perform the audit to obtain sufficient,  appropriate evidence to provide a reasonable basis for our findings and  conclusions based on our audit objectives. We believe that the evidence  obtained provides a reasonable basis for our findings and conclusions  based on our audit objectives.
subsections: section_title: Background
paragraphs: Several federal departments and agencies have responsibilities for  assessing the threat of CBRN agents and determining requirements and  priorities for developing and acquiring medical countermeasures for these  agents, as part of their mission and, in some cases, as specifically required  by law.
DHS leads federal interagency coordination and planning for emergency  response to catastrophic CBRN incidents. Under the Project BioShield Act  of 2004, DHS is required, in consultation with HHS, to assess the threat of  CBRN agents.
HHS leads the federal medical and public health response to potential  CBRN incidents.
HHS established PHEMCE in 2006. PHEMCE is a federal interagency  decision-making body responsible for providing recommendations to the  Secretary of HHS on (1) prioritized requirements for CBRN medical  countermeasures, (2) coordination of medical countermeasure  development and acquisition activities to address the requirements, and  (3) strategies for distributing medical countermeasures held in the U.S.  Strategic National Stockpile (SNS), the national repository of medications,  medical supplies, and equipment for use in a public health emergency. As  required by the Pandemic and All-Hazards Preparedness Act of 2006,  PHEMCE also conducts annual reviews of the SNS, the results of which  are used to make necessary additions or modifications to its contents.  PHEMCE is composed primarily of officials from HHS’s ASPR, BARDA,  CDC, FDA, and NIH, which also have specific agency responsibilities for  countermeasure development and acquisition. In addition, PHEMCE  includes officials from DHS, the Department of Defense (DOD), the  Department of Veterans Affairs, the Department of Agriculture, and the  Executive Office of the President.
Within HHS, ASPR is responsible for leading federal government efforts to  research, develop, evaluate, and acquire public health emergency medical  countermeasures to prevent, treat, or mitigate the potential health effects  from exposure to CBRN agents. Under the Project BioShield Act, HHS is  responsible for arranging for the acquisition of certain medical  countermeasures, some of which may not yet be FDA-approved or  licensed. These countermeasures also include those for children and  other vulnerable populations, such as those for the elderly and  immunocompromised individuals. The Project BioShield Act authorized  the Special Reserve Fund for acquisition of these countermeasures.
Within ASPR, BARDA—established by the Pandemic and All-Hazards  Preparedness Act of 2006—is responsible for overseeing and funding  advanced development and acquisition of CBRN medical  countermeasures.
CDC is responsible for maintaining the SNS. CDC also supports state and  local public health departments in their efforts to detect and respond to  public health emergencies such as CBRN incidents, including providing  guidance and recommendations for the mass distribution and use of  medical countermeasures.
FDA is responsible for assessing the safety and effectiveness of CBRN  medical countermeasures and regulates their development, approval and  licensure, and postmarket surveillance. FDA also provides technical  support for the development of tools to support medical countermeasure  development. Under the Project BioShield Act, as delegated by the HHS  Secretary, FDA may temporarily authorize the emergency use of  unapproved or unlicensed medical products in certain circumstances  through emergency use authorizations (EUA).
The National Institutes of Health (NIH) is responsible for conducting and  coordinating basic and applied research to develop new or enhanced  medical countermeasures and related medical tools for CBRN agents.
The National Biodefense Science Board (NBSB), established by the  Pandemic and All-Hazards Preparedness Act, provides the HHS Secretary  with expert advice and guidance on scientific and technical matters  related to current and future CBRN agents, including those that occur  naturally.
DOD has exclusive responsibility for research, development, acquisition,  and deployment of medical countermeasures to prevent or mitigate the  health effects of CBRN agents and naturally occurring diseases on Armed  Forces personnel. Under the PHEMCE structure, DOD also coordinates  with HHS on the Integrated Portfolio to identify common medical  countermeasure priorities.
section_title: HHS, Through PHEMCE, Uses a Four-Step Process to Determine Acquisition Priorities for Medical Countermeasures and Oversees Their Development
paragraphs: HHS coordinates and leads federal efforts to determine CBRN medical  countermeasure priorities and develop and acquire CBRN medical  countermeasures, primarily through PHEMCE. HHS’s medical  countermeasure acquisition strategy is based on a four-step process: (1)  identify and assess the threat of CBRN agents, (2) assess medical and  public health consequences of attacks with these agents,   (3) establish medical countermeasure requirements, and (4) identify and  prioritize near-, mid-, and long-term development and acquisition  programs. Because desired CBRN medical countermeasures may not be  immediately available for acquisition, HHS oversees and supports the  various stages of research and development of these countermeasures,  also under PHEMCE. (See fig. 1.)
With input from HHS, DHS leads the first step in the process to assess, on  an ongoing basis, the threat of CBRN agents and determine which of these  agents pose a material threat to national security, as required by the  Project BioShield Act. The material threat assessments (MTA) that DHS  issues examine the threat posed by given CBRN agents or classes of agents  for plausible, high-consequence scenarios and provide estimates of the  number of people exposed to different dose levels of an agent in the  scenarios. Since 2004, DHS has determined that 13 of these CBRN agents  pose a material threat, based on the MTAs.
In the second step, HHS and its PHEMCE partners use the data from the  MTA scenarios to assess the public health and medical consequences of an  attack using these agents. Public health consequence modeling estimates  the number of individuals who may become ill, be hospitalized, or die from  exposure to and infection with CBRN agents, with or without medical  intervention. To develop these estimates from the MTA exposure data,  HHS consults with experts and uses available scientific data, such as data  on how much of an agent is needed to cause infection and how long it  takes to develop symptoms of disease after exposure. In addition, HHS  assesses the status of current countermeasure development and  availability, including applicable countermeasures that DOD may be  developing. Through consequence modeling, HHS determines the public  health impact on the affected population in terms of the potential health  effects throughout the course of disease based on different time frames for  medical countermeasure delivery and treatment. According to HHS  officials, consequence modeling allows PHEMCE to consider public health  preparedness needs, such as whether a particular countermeasure is  plausible or feasible for a certain CBRN agent and the amount that would  be needed.
In the third step, PHEMCE uses the consequence modeling results to  determine requirements for needed medical countermeasures, including  the needed quantity and the desired characteristics, such as how they  would be used and stored. HHS officials told us that these requirements  would include the preferred method of administration, such as oral  administration of a medicine that can be stored at room temperature.  PHEMCE partners consult with experts and incorporate intelligence  information and information on state and local response capabilities to  determine ideal countermeasure characteristics. If countermeasures that  meet these characteristics are not immediately available, HHS may acquire  countermeasures that are currently available and work with  manufacturers over time to develop countermeasures that better meet the  ideal characteristics.
In the fourth step, the established medical countermeasure requirements  help HHS assess and prioritize its countermeasure investments, and,  according to HHS officials, form the basis for development and acquisition  solicitations and contracts. Based on the requirements, in 2007, PHEMCE  set its medical countermeasure acquisition priorities to focus on spending  the remainder of the Project BioShield Special Reserve Fund for certain  CBRN agents that DHS determined posed a material threat to national  security. In addition, PHEMCE priorities focus on obtaining medical  countermeasures for postexposure prevention or treatment of disease  caused by those CBRN agents. HHS grouped these priorities in time  frames for the near term (fiscal year 2007 through fiscal year 2008),  midterm (fiscal year 2009 through fiscal year 2013), and long term (beyond  fiscal year 2013). PHEMCE’s stated priorities include acquiring diagnostics  for each biological agent deemed a material threat, smallpox vaccine,  medical countermeasures for Ebola and Marburg viruses, and medications  to treat the acute and delayed effects of radiation. PHEMCE also uses the  results of its annual SNS review to reassess prioritization of CBRN medical  countermeasures, based on any SNS acquisitions made after the initial  2007 prioritizations.
BARDA oversees the acquisition and delivery of medical countermeasures  into the SNS. If a medical countermeasure is not FDA-approved or  licensed, its acquisition is funded by BARDA using the Project BioShield  Special Reserve Fund. If a medical countermeasure is FDA-approved or  licensed for use in treating the health effects of a CBRN agent, CDC  purchases the countermeasure for the SNS. HHS officials told us that once  FDA approves or licenses a countermeasure acquired with the Special  Reserve Fund, BARDA is still responsible for overseeing its acquisition  through the end of the Project BioShield contract. BARDA is also  responsible for negotiating with the manufacturer to obtain additional  quantities of the countermeasure in the event of a CBRN attack. CDC  officials told us that they develop a 5-year project plan for each  countermeasure in the SNS upon acquisition to evaluate specific needs  over time—such as shelf life, replacement costs of expiring products, and  storage and space requirements—and update the plan every year, or more  frequently if conditions change.
HHS officials told us that of the few available medical countermeasures  for CBRN agents, some are FDA-approved or licensed specifically for  CBRN use. Other countermeasures that HHS has acquired for CBRN use  have been approved or licensed for other uses only. For example, there  are no currently available rapid diagnostic tools for any of the biological  agents that DHS deemed material threats other than anthrax, nor are there  any available medical countermeasures for postexposure prevention of  disease for Ebola and Marburg viruses.
NIH and BARDA oversee and support CBRN medical countermeasure  research and development, which is conducted in several stages. (See   fig. 1.)
Early research: Early, or basic, research seeks to better understand CBRN  agents and the response of the host organism to the agents through the  study of the cellular and molecular biology of agents and hosts, their  physiologic processes, and their genome sequences and structures.  According to NIH officials, individual researchers typically initiate  research in this stage. NIH assesses these research projects and their  application for specific CBRN agents.
Applied research: Applied, or translational, research builds on basic  research by validating and testing concepts in practical settings to identify  potential products. NIH officials told us that the agency funds applied  research to identify scientific or practical limitations that may affect the  potential of a scientific concept to develop into a medical countermeasure  product.
Early development: NIH moves successful concepts from the applied  research stage into the early development stage, in which it funds research  to demonstrate basic safety, reproducibility, and ability to be used in  humans. In its requests for research proposals for early development, NIH  officials told us that the agency specifies its needs by product modes and  categories, such as therapeutics, diagnostics, and vaccines; NIH can  further specify the characteristics of a medical countermeasure, and  companies agree to the terms of the contract up front.
Advanced development: BARDA oversees and funds CBRN advanced  research and development. In this stage, potential medical  countermeasures are further evaluated in animal studies to demonstrate  safety and effectiveness for preventing, diagnosing, or treating disease in  humans. Successful products are then available for development and  acquisition. In addition, in this stage, BARDA determines that  manufacturing, scale-up production, and licensing of countermeasures can  be achieved in a timely and reliable manner. BARDA also awards contracts  using the Project BioShield Special Reserve Fund to acquire medical  countermeasures for the SNS that are reasonably expected to qualify for  FDA approval or licensure within 8 years.
section_title: Challenges to Development and Acquisition of Medical Countermeasures Include High Failure Rates in Research and Difficulties Meeting Regulatory Requirements
paragraphs: The federal government faces a variety of challenges in developing and  acquiring medical countermeasures, such as the high failure rate in  research and development and difficulties meeting regulatory  requirements. One scientific challenge is that, as with other medical  products, the failure rate for development of certain CBRN medical  countermeasures can be high, depending on the stage of scientific  research and development. HHS estimates that the failure rate for  development and licensure of most drugs, vaccines, and diagnostic devices  in the early development stage can be more than 80 percent, with an  increasing probability of success as the product moves further through  development. Because most CBRN research does not result in viable  medical countermeasures, HHS officials told us that they try to fund a  larger set of candidates in earlier stages of research in order to increase  the likelihood that at least one candidate countermeasure may be  successful. HHS officials noted that they would ideally prefer to have at  least two successfully developed medical countermeasures from different  manufacturers available for a particular CBRN agent for several reasons,  such as if certain segments of the population are resistant to one of the  countermeasures or if one of the companies experiences manufacturing  problems.
Given the high risk of failure in research, as well as a lack of a commercial  market for most CBRN countermeasures, attracting companies  experienced in meeting the complex requirements necessary to develop a  new product is also challenging. The private sector—especially large  pharmaceutical companies—has little incentive to invest millions of  dollars to develop a potential new medical countermeasure because the  lack of a commercial market makes a return on investment less likely or  less lucrative. The Project BioShield Act facilitates the creation of a  government market by authorizing the government to commit to make the  Special Reserve Fund available to acquire certain medical  countermeasures, including those that are not yet licensed or approved,  provided they meet certain conditions. In addition, the Pandemic and All- Hazards Preparedness Act established BARDA to support advanced  research and development by, for example, awarding contracts and grants  for countermeasure advanced research and development. BARDA  provides funding for advanced research and development for those  countermeasures that are not eligible for the Special Reserve Fund.  Nevertheless, despite the Special Reserve Fund and BARDA support, HHS  and others have noted that engaging large pharmaceutical companies  remains a challenge. In addition, smaller biotechnology companies  conducting much of the research and development for medical  countermeasures generally have less experience with drug development.  As a result, FDA officials told us that they have to provide more regulatory  and scientific guidance to these companies than they might provide to  larger pharmaceutical companies, which generally have more experience  with bringing products through the regulatory process.
There are also several challenges related to the regulatory processes for  evaluating the development of promising medical countermeasures. For  example, researchers face challenges proving the effectiveness of  potential countermeasures because they cannot ethically or feasibly test  the effectiveness of countermeasures on humans due to the dangers posed  by CBRN agents. However, because FDA requires evidence of a  countermeasure’s effectiveness for approval or licensure, researchers can  submit evidence of effectiveness obtained from appropriate studies in  animals in accordance with FDA’s Animal Rule. The Animal Rule states  that in selected circumstances, when it is neither ethical nor feasible to  conduct human efficacy studies, FDA may grant marketing approval based  on adequate and well-controlled animal studies when the results of those  studies establish that the drug or biological product is reasonably likely to  produce clinical benefit in humans. Under this rule, researchers can  demonstrate effectiveness of medical countermeasures if the way a  disease occurs in the animal being studied adequately mimics the way the  disease occurs in humans. However, animals that manifest the disease in  the same way as humans may not always exist for a given CBRN agent.  For example, according to FDA officials, smallpox occurs only in humans,  and related viruses that occur in animals, such as monkey pox, may not be  similar enough to mimic smallpox in humans. Because of the complexities  of using animal studies as models for human reactions to agents and  potential countermeasures, FDA would prefer to meet with researchers  earlier and more frequently, and FDA takes longer to evaluate product  applications for CBRN medical countermeasures than to evaluate other  medical products. In addition, the NBSB and others have reported that  researchers face difficulty in applying FDA’s draft guidance on the Animal  Rule, which is currently under revision. According to the guidance, the  agent tested in the animal must be identical to the agent that causes  human disease. However, as discussed above, some animal studies may  not meet that criterion and therefore cannot be used to demonstrate a  countermeasure’s effectiveness. To date, FDA has not approved any newly  developed CBRN medical countermeasures based on animal model  testing.
Determining appropriate doses of CBRN countermeasures for children,  who may be more vulnerable to the adverse effects of a CBRN agent, also  involves regulatory challenges. Most approved or licensed CBRN medical  countermeasures have been approved for use in adults only and lack  pediatric dosing information. In addition, several candidate medical  countermeasures currently in development lack or have limited pediatric  dosing information. Regulations restrict children’s participation in clinical  trials when they do not benefit from them; therefore, developing  pediatric dosing information relies on existing adult data or data from  animal studies.
There are also challenges in the processes for evaluating the emergency  use of a promising medical countermeasure that has not been FDA- approved or licensed for treatment or postexposure prevention of disease  for a given CBRN agent. In order for the government to use an unapproved  countermeasure to respond to a CBRN event, FDA must issue an EUA.  FDA can issue EUAs only after the HHS Secretary declares a public health  emergency. In order for FDA to issue an EUA, CDC or another government  or private entity has to submit detailed information for FDA to evaluate,  such as available safety and effectiveness information, a discussion of  risks and benefits of using the unapproved countermeasure, draft fact  sheets for health care providers and patients, and instructions for using  the countermeasure. While CDC or other entities may submit all available  data for FDA review in advance, such as when CDC acquires a  countermeasure for the SNS, the agency must formally submit the EUA  request at the time of the declared emergency. In the event of an attack  with a CBRN agent that can cause disease within hours or days after  exposure, CDC and FDA would have to process the final documents  quickly in order for FDA to issue EUAs for appropriate medical  countermeasures. Further, the Project BioShield Act precludes the use of  data collected during the emergency use of an unapproved product to  constitute a clinical investigation to support later product approval.
Finally, CDC faces the logistical challenge of ongoing replenishment of  expiring medical countermeasures in the SNS. CDC can work with FDA to  extend the expiration date of certain drugs in the stockpile, and thereby  defer the cost of replacing the countermeasure and extend its availability  for use in a potential CBRN event. In such cases, however, FDA has to  conduct studies to ensure stability and quality of each drug. In addition,  CDC faces the cost of relabeling the products to reflect the new expiration  date. If the shelf life of an expiring countermeasure cannot be extended,  CDC must replace it. For some countermeasures in the SNS, CDC may not  face this challenge. For example, CDC officials told us that anthrax  vaccine is moved out of the SNS before expiration because CDC rotates it  out to DOD facilities for routine use. In addition, other countermeasures  may be held for the SNS by private vendors and can be used commercially,  provided that the vendors hold a certain amount for use in the event of a  public health emergency.
Chairman Bilirakis, this concludes my prepared statement. I would be  happy to answer any questions that you, Ranking Member Richardson, or  other Members of the Subcommittee may have.
section_title: GAO Contact and Staff Acknowledgments
paragraphs: For further information about this statement, please contact Cynthia A.  Bascetta at (202) 512-7114 or bascettac@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on the  last page of this statement. Key contributors to this statement were Marcia  Crosse, Director; Sheila K. Avruch, Assistant Director; Shana R. Deitch;  Tracey King; Corissa Kiyan; Carolina Morgan; and Roseanne Price.
section_title: Appendix I: Abbreviations
paragraphs: This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.