Order Code RS22602
Updated February 13, 2008
Public Health and Medical Preparedness
and Response: Issues in the 110th Congress
Sarah A. Lister
Specialist in Public Health and Epidemiology
Domestic Social Policy Division
Summary
Key recent events — the 2001 terrorist attacks, Hurricane Katrina, and concerns
about an influenza (“flu”) pandemic — have sharpened congressional interest in the
nation’s systems to track and respond to public health threats. The 109th Congress
passed laws that reauthorized public health and medical preparedness and response
programs in the Department of Health and Human Services (HHS), and reorganized
parts of the Department of Homeland Security (DHS), including the establishment of
an Office of Health Affairs (OHA), and reorientation of the mission and authorities of
the Federal Emergency Management Agency (FEMA). In its second session, the 110th
Congress is likely to continue its oversight of the implementation of these laws, focusing
in particular on such matters as (1) how well equipped HHS and DHS are — in terms
of authority, funding, policies, and workforce — to respond to complex health
emergencies; (2) how well they and other federal agencies coordinate their preparedness
and response efforts with each other; (3) the status of major federal initiatives, such as
pandemic flu preparedness, biodefense research and development, and disaster planning
for at-risk populations; and (4) the effect of the impending presidential transition on
authorities and programs that were established during the current administration. This
report, which will be updated, discusses key issues in public health and medical
preparedness and response, citing additional CRS reports and other resources.
Background and Legislation in the 109th Congress
In December 2006, Congress passed the Pandemic and All-Hazards Preparedness
Act (PAHPA, P.L. 109-417), extending programs for public health emergency
preparedness and response activities in HHS, and establishing a Biomedical Advanced
Research and Development Authority (BARDA) in HHS to develop medical
countermeasures (e.g., diagnostic tests, drugs, and vaccines). In October 2006, Congress
passed the Post-Katrina Emergency Management Reform Act of 2006 (PKA, Title VI of
P.L. 109-295), which reorganized DHS and, within it, FEMA. The act also codified the
position of Chief Medical Officer, with primary responsibility within DHS for medical
issues related to natural and man-made disasters and terrorism. Pursuant to these laws,

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HHS’s efforts in public health and medical preparedness and response are led by the
Assistant Secretary for Preparedness and Response (ASPR, currently RADM W. Craig
Vanderwagen), and related activities in DHS are coordinated by the Assistant Secretary
for Health Affairs and Chief Medical Officer (currently Jeffrey W. Runge).1
Issues in the 110th Congress
Federal Leadership and Coordination. The PKA provided that the DHS Chief
Medical Officer “shall have the primary responsibility within the Department for medical
issues related to natural disasters, acts of terrorism, and other man-made disasters,” while
the PAHPA provided that the “Secretary of [HHS] shall lead all Federal public health and
medical response to public health emergencies and incidents....”2 (Emphasis added.) The
Government Accountability Office (GAO) noted, in the context of pandemic flu planning,
that “... these leadership roles involve shared responsibilities, and it is not clear how these
would work in practice.”3 GAO recommended that DHS and HHS conduct training and
exercises to ensure that federal leadership roles are clearly defined and understood.
The Presidential Transition. The transition to a new administration in January
2009 will mark the first such transition for agencies and programs that were established
following the 2001 terrorist attacks. These include the Office of the HHS ASPR and all
of the newly established (versus “legacy”) agencies and programs in DHS, including the
Office of Health Affairs (OHA). The transition may be especially challenging for OHA,
which is in the midst of rapid growth in funding and staffing. OHA was established (first
as the office of the Chief Medical Officer) in 2005, received $2 million in FY2006, and
grew to $117 million in FY2008, with $161 million requested for FY2009. OHA is in the
process of hiring permanent staff to carry out a variety of new responsibilities.
HHS Response Capability. The 110th Congress may consider the adequacy of
permanent authorities of the HHS Secretary for responding to public health threats,
including authority to declare a public health emergency. Members of Congress may also
consider how HHS funds disaster response activities that are not reimbursable by FEMA.
Though the HHS Secretary has authority for a no-year Public Health Emergency Fund,
Congress has not appropriated monies to the fund for many years.4
1 See HHS, Assistant Secretary for Preparedness and Response, at [http://www.hhs.gov/aspr], and
DHS, Office of Health Affairs, at [http://www.dhs.gov/xabout/structure/editorial_0880.shtm].
See also CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L.
109-417): Provisions and Changes to Preexisting Law, by Sarah A. Lister and Frank Gottron
(hereafter CRS Report RL33589), and CRS Report RL33729, Federal Emergency Management
Policy Changes After Hurricane Katrina: A Summary of Statutory Provisions, by Keith Bea,
Coordinator (hereafter CRS Report RL33729).
2 P.L. 109-295, 120 Stat. 1409; P.L. 109-417, §101, 120 Stat. 2832.
3 GAO, “Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership Roles and
Improve Pandemic Planning,” GAO-07-1257T, September 26, 2007. See also CRS Report
RL33579, The Public Health and Medical Response to Disasters: Federal Authority and
Funding, by Sarah A. Lister (hereafter CRS Report RL33579).
4 See CRS Report RL33579.

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State Grants for Public Health and Hospital Preparedness. Since 2002,
Congress has provided more than $9 billion in grants to states to strengthen public health
and hospital preparedness for public health threats. The PAHPA extended the programs,
adding authority to withhold funds for failure to meet program requirements, a state
matching requirement, and a requirement that the Secretary of HHS publish certain
information about program activities and performance on a public website.5
Biodefense Research. Several federal agencies support biodefense research.
These include the Science and Technology Directorate in DHS, the National Institutes of
Health in HHS, the Department of Defense, and the U.S. Department of Agriculture
(USDA). The National Biodefense Analysis and Countermeasures Center (NBACC) was
recently established by DHS to study biological threats, assess vulnerabilities and
potential consequences, and establish a national capability for forensic analysis of
evidence from bio-crimes and terrorism. DHS has also requested funding to build a new
facility, the National Bio- and Agro-Defense Facility (NBAF), to house high-containment
laboratories for the study of foreign animal diseases, such as Foot and Mouth Disease.6
Project BioShield. The 108th Congress launched Project BioShield to encourage
the development of countermeasures that lack commercial markets. In the PAHPA, the
109th Congress required the HHS Secretary to develop and publish a strategic plan to
guide HHS countermeasures research, development, and procurement. The act also
established the Biodefense Advanced Research and Development Authority (BARDA)
in HHS to help implement the strategic plan, support countermeasure development, and
facilitate communication between the government and developers. The 110th Congress
is likely to remain interested in the progress of Project BioShield and, depending on
appropriations, to oversee the establishment and effectiveness of BARDA.7
Vulnerable Populations. The terrorist attacks of 2001 and the hurricanes of 2005
showed that some people may be at greater risk, or more in need of special services,
during and following a disaster. The PAHPA required the Secretary of HHS to consider,
in planning, the needs of at-risk individuals, defined as children, pregnant women, senior
citizens, and others as determined by the Secretary. The PKA required the head of FEMA
to appoint a Disability Coordinator, charged, among other things, with coordinating
emergency management policies and practices for individuals with disabilities.8
Pandemic Influenza Preparedness. To prepare for the threat of a human flu
pandemic, the 109th Congress provided $6.1 billion in emergency supplemental funding
for FY2006. Most of this funding supports an HHS initiative to expand domestic vaccine
5 See CRS Report RL33589.
6 See CRS Report RL32891, The National Biodefense Analysis and Countermeasures Center:
Issues for Congress, by Dana A. Shea, and CRS Report RL34160, The National Bio- and
Agro-Defense Facility: Issues for Congress, by Dana A. Shea, Jim Monke, and Frank Gottron.
7 See CRS Report RS21507, Project BioShield: Purposes and Authorities, by Frank Gottron;
CRS Report RL33907, Project BioShield: Appropriations, Acquisitions, and Policy
Implementation Issues for Congress, by Frank Gottron; and CRS Report RL33589.
8 See CRS Report RS22254, The Americans with Disabilities Act and Emergency Preparedness
and Response, by Nancy Lee Jones; CRS Report RL33589; and CRS Report RL33729.

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production capacity. In addition to oversight of federal spending for pandemic flu,
Congress may be interested in other matters, such as (1) federal coordination of pandemic
preparedness and response; (2) state, local, and private sector pandemic preparedness; (3)
the impact of avian flu on affected countries; and (4) the possible effects of a flu
pandemic on global trade and commerce.9
Disaster Victims and Health Care. The United States lacks a comprehensive
health insurance system to pay for medical and supportive services for all persons who
might be victims of a natural disaster, terrorist incident, or other public health emergency.
As of 2006, about 47 million persons in the United States were uninsured. In the face of
a catastrophic incident, enormous pressure would likely be placed on hospitals,
physicians, and other providers to deliver care to these individuals without a clear source
of reimbursement. Consensus has not been reached about the role of the federal
government in addressing these barriers to coverage.10 Several bills in the 110th Congress
would address the health care needs of responders and others who were exposed to
hazards at the World Trade Center following the September 11, 2001, attack, and who are
now experiencing health problems.11 Following Hurricane Katrina, Congress provided
$2 billion to cover the state share of Medicaid costs associated with evacuees and
individuals living in declared disaster areas (for states with approved federal waivers), and
to restore access to care in affected areas.12 The Louisiana Health Care Redesign
Collaborative, a federal, state, local, and private partnership, was developed to propose
options for rebuilding the healthcare system in southern Louisiana through a Medicaid
waiver and Medicare demonstration proposal.13
9 See CRS Report RS22576, Pandemic Influenza: Appropriations for Public Health
Preparedness and Response, by Sarah A. Lister; CRS Report RL33145, Pandemic Influenza:
Domestic Preparedness Efforts, by Sarah A. Lister; CRS Report RL34190, Pandemic Influenza:
An Analysis of State Preparedness and Response Plans, by Sarah A. Lister and Holly Stockdale;
CRS Report RL33219, U.S. and International Responses to the Global Spread of Avian Flu:
Issues for Congress, by Tiaji Salaam-Blyther; CRS Report RL33795, Avian Influenza in Poultry
and Wild Birds, by Jim Monke and M. Lynne Corn; CRS Report RL33871, Foreign Countries’
Response to the Avian Influenza (H5N1) Virus: Current Status, by Emma Chanlett-Avery,
Coordinator; and CRS Report RS22453, Avian Flu Pandemic: Potential Impact of Trade
Disruptions, by Danielle Langton.
10 See “Federal Assistance for Disaster-Related Healthcare Costs,” in CRS Report RL33579, and
CRS Report RL33927, Selected Federal Compensation Programs for Physical Injury or Death,
by Sarah A. Lister and C. Stephen Redhead.
11 See, for example, H.R. 1414/S. 201, H.R. 1247, and H.R. 3543.
12 See Government Accountability Office, Hurricane Katrina: Allocation and Use of $2 Billion
for Medicaid and Other Health Care Needs, GAO-07-67, February 28, 2007.
13 See hearing on “Post Katrina Health Care: Continuing Concerns and Immediate Needs in the
New Orleans Region,” House Committee on Energy and Commerce, Subcommittee on Oversight
and Investigations, March 13, 2007, and the Louisiana Healthcare Redesign Collaborative, at
[http://www.dhh.louisiana.gov/offices/?ID=288]. See also CRS Report RL33579; CRS Report
RL33083, Hurricane Katrina: Medicaid Issues, by Evelyne P. Baumrucker et al.; and CRS
Report RL33738, Gulf Coast Hurricanes: Addressing Survivors’ Mental Health and Substance
Abuse Treatment Needs, by Ramya Sundararaman, Sarah A. Lister, and Erin D. Williams
(hereafter CRS Report RL33738).

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Health emergencies often involve scarcities of resources, including personnel,
equipment, drugs, and vaccines. Prioritizing the use of these resources to maximize
benefit requires careful study of scientific and medical evidence, and raises complex legal
and ethical questions that are best considered before emergencies arise.14 Also, many are
concerned that the nation’s health care system, which is often overburdened by routine
demands, would not be able to handle surges in demand that could result from some types
of disasters. The PAHPA requires the HHS Secretary to assess national medical response
capability in a quadrennial National Health Security Strategy, and authorizes HHS to
acquire mobile medical assets, such as field hospitals.15 Finally, Congress may consider
the effectiveness of programs to deliver mental health counseling services to disaster
victims, and whether these services are well coordinated and well targeted.16
Authorities to Control Communicable Diseases. The response to
communicable disease threats may involve movement restrictions, business and school
closures, compulsory treatments, and other constraints. While state and local governments
have the primary authority over these domestic containment measures, a comprehensive
response to a public health emergency may involve overlapping governmental authorities
and attendant legal and economic issues. Recent incidents have expanded Congress’s
longstanding interest in the security of U.S. borders to include concerns about
communicable diseases in travelers, which is a matter of federal jurisdiction. These
incidents have brought into question the divisions of authority and effectiveness of
coordination among federal agencies that are responsible for disease control, and for the
security of the borders and the transportation infrastructure. Policy makers have noted that
if these systems are unable to respond to common and expected infectious disease threats
such as tuberculosis, they may also be unable to respond to more serious threats such as
pandemic flu or bioterrorism. Effective solutions are elusive, but would ideally address
scientific, technical, and economic constraints; the balance of individual and collective
rights; and the roles of federal, state, and local authorities, and foreign governments.17
Workforce Surge Capacity. The health workforce is aging into retirement, yet
is strained by new homeland security duties. HHS manages several health professions
programs geared toward alleviating shortages and maldistributions of physicians, nurses,
and others who provide individual health care services. The public health workforce has,
in contrast, received little federal attention until recently. The PAHPA authorized a loan
repayment demonstration project for individuals who serve in state or local health
departments in defined areas of need. Other efforts to bolster the ranks of health
14 See CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce
Medical Resources During a Pandemic, by Nancy Lee Jones.
15 See CRS Report RL33589.
16 See CRS Report RL33738.
17 See CRS Report RL33201, Federal and State Quarantine and Isolation Authority, by Kathleen
S. Swendiman and Jennifer K. Elsea; CRS Report RL34144, Extensively Drug-Resistant
Tuberculosis (XDR-TB): Emerging Public Health Threats and Quarantine and Isolation, by
Kathleen S. Swendiman and Nancy Lee Jones; CRS Report RL33609, Quarantine and Isolation:
Selected Legal Issues Relating to Employment, by Nancy Lee Jones and Jon O. Shimabukuro;
CRS Report RS22219, The Americans with Disabilities Act (ADA) Coverage of Contagious
Diseases, by Nancy Lee Jones; and CRS Report RS21414, Mandatory Vaccinations: Precedent
and Current Laws, by Kathleen S. Swendiman.

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professionals for emergency response also include ensuring civil liability protection for
volunteer health professionals and establishing a system to verify their licenses and
credentials. While efforts are ongoing among states and on the federal level, a uniform
system for protection of volunteer health professionals does not yet exist.18
Liability, Compensation, and Intellectual Property Issues. In December
2005, Congress passed Department of Defense Emergency Supplemental Appropriations,
2006 (P.L. 109-148), including Division C, titled the “Public Readiness and Emergency
Preparedness Act” (PREP Act). Upon a declaration of emergency, the PREP Act
eliminates liability, except in the case of willful misconduct, of manufacturers and others
involved in the production and use of countermeasures.19 In February 2007, HHS
Secretary Leavitt made such a declaration with respect to pandemic flu vaccine.20 The law
also establishes, in the U.S. Treasury, a “Covered Countermeasure Process Fund,” and
requires the HHS Secretary to develop a compensation mechanism for those who may be
harmed by a covered countermeasure. As of FY2008, the fund has not received an
appropriation; none is requested for FY2009. Finally, intellectual property protections
may affect the availability of countermeasures by making them more commercially
attractive to developers, or more costly to purchasers, including governments.21
Expired Program Authorities. The 110th Congress may consider reauthorization
of some expired preparedness and response programs.22 These include the Select Agent
Program, which is jointly managed by the Centers for Disease Control and Prevention
(CDC) and USDA’s Animal and Plant Health Inspection Service (APHIS) to regulate
certain biological pathogens and toxins that could be used for bioterrorism. Program
authority expired at the end of FY2007.23 In addition, authority for HHS health
professions programs expired in 2002. These programs have not focused on emergency
preparedness and response in the past, though the last reauthorization in 1998 preceded
heightened concerns in this area.24 Finally, while authority for the Strategic National
Stockpile of countermeasures has been amended several times since the terror attacks of
2001, general program authority, which expired at the end of FY2006, was not extended.25
18 See CRS Report RS22255, Emergency Response: Civil Liability of Volunteer Health
Professionals, by Kathleen Swendiman and Nathan Brooks; CRS Report RL32546, Title VII
Health Professions Education and Training: Issues in Reauthorization, by Bernice
Reyes-Akinbileje (hereafter CRS Report RL32546); and CRS Report RL33589.
19 See CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability
Limitation, by Henry Cohen and Vanessa K. Burrows.
20 72 Federal Register 4710-4711, February 1, 2007.
21 See CRS Report RL32917, Bioterrorism Countermeasure Development: Issues in Patents and
Homeland Security, by Wendy H. Schacht and John R. Thomas, and CRS Report RL33159,
Influenza Antiviral Drugs and Patent Law Issues, by Brian T. Yeh.
22 See Congressional Budget Office, “Unauthorized Appropriations and Expiring Authorizations,”
January 2008, at [http://www.cbo.gov/ftpdoc.cfm?index=8920&type=1].
23 42 U.S.C. §262a and 7 USCS §8401. See CDC Select Agent Program, at [http://www.cdc.gov/
od/sap/], and APHIS Agricultural Select Agent Program, at [http://www.aphis.usda.gov/
programs/ag_selectagent/].
24 See CRS Report RL32546.
25 See CRS Report RL33589.

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