Order Code RS22602
Updated June 6, 2007
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
The nation’s systems to address public health threats such as bioterrorism gained
renewed interest following the 2001 terrorist attacks. The 109th Congress reauthorized
comprehensive public health preparedness laws, reflecting lessons from the Hurricane
Katrina response and concerns about a flu pandemic. The 109th Congress also
completed a statutory reorganization of the Federal Emergency Management Agency
(FEMA). The 110th Congress is likely to study the implementation of these two laws,
and other issues in public health and medical preparedness and response.
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 bioterrorism and other public health
emergency preparedness and response activities in the Department of Health and Human
Services (HHS), and establishing a Biomedical Advanced Research and Development
Authority (BARDA) in HHS to develop medical countermeasures (e.g., diagnostic tests
and drugs and vaccines). In October 2006, Congress passed Department of Homeland
Security appropriations for FY2007 (P.L. 109-295). Title VI of the act incorporated the
Post-Katrina Emergency Management Reform Act of 2006 (the Post-Katrina Act), which
reorganizes the Department of Homeland Security (DHS) and, within it, the Federal
Emergency Management Agency (FEMA). The act also codifies the position of Chief
Medical Officer, with primary responsibility within DHS for medical issues related to
natural and man-made disasters and terrorism.1 The 110th Congress is likely to be keenly
interested in implementation of these laws, and others, that address the readiness of the
1 See 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
RL33589), and CRS Report RL33729, Federal Emergency Management Policy Changes After
Hurricane Katrina: A Summary of Statutory Provisions, Keith Bea, Coordinator (hereafter CRS
Report RL33729).

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nation’s public health and medical systems. This report, which will be updated, discusses
key issues in public health and medical preparedness and response, and cites additional
CRS reports and other resources.
Issues in the 110th Congress
Federal Coordination. In planning for public health and medical emergencies,
the roles of the Secretaries of HHS and DHS are not always clear. Activities in the two
departments dovetail in biodefense research and development, state and local disaster
preparedness and response, domestic and global infectious disease surveillance, the
deployment of medical response assets, mental health counseling for disaster victims, and
other areas. The Assistant Secretary for Preparedness and Response leads HHS’s efforts
in public health and medical preparedness and response. The Chief Medical Officer
coordinates comparable activities in DHS. Certain issues regarding these positions and
their respective roles were addressed in legislation in the 109th Congress.2 The 110th
Congress is likely to be interested in how statutory directives are carried out.
HHS Response Capability. Given the disaster response obligations of HHS,
many question whether the department has the resources — financial, logistical, technical,
and otherwise — to effectively carry out its responsibilities. 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.3 Though the HHS Secretary has authority for a no-year
emergency fund, Congress has not appropriated monies to the fund for many years.
Finally, Congress may consider the permanent authority of the President — acting through
the FEMA Director, in consultation with HHS — to deliver mental health counseling
services to disaster victims, and whether these services are effective and well targeted.4
State Grants for Public Health and Hospital Preparedness. Since 2002,
Congress has provided about $7 billion in grants to states to strengthen public health and
hospital preparedness for public health threats. HHS has not published comprehensive
or state-specific information regarding grantees’ performance, presumably because of
national security concerns. Congress has been interested in the management of these
grants, including fiscal accounting mechanisms, the balance of federal-versus-state
funding shares, the development of program goals, and program transparency. The
PAHPA extends the programs, adding certain new elements including federal authority
to withhold funds for failure to meet program requirements, a state matching requirement,
2 Ibid. 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); 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).
3 Pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford
Act, administered by DHS), FEMA may reimburse other federal agencies for activities carried
out in response to presidentially declared emergencies and major disasters.
4 See CRS Report RL33579 and CRS Report RL33738.

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and a requirement that the Secretary of HHS publish certain information about program
activities and performance on a federal Internet website available to the public.5
Biodefense Research and Development. Several federal agencies conduct
or fund research on potential biological weapons, the detection of bioterrorist incidents
and outbreaks of naturally occurring infections, and potential tests and treatments for use
on affected individuals. The two principal agencies involved in civilian research are the
Science and Technology Directorate in DHS, for research to address vulnerabilities and
assess risks to the civilian population and infrastructure related to biological, chemical,
radiological and nuclear threats, and high explosives; and the National Institutes of Health
in HHS, for biomedical research and the development of medical countermeasures.6 The
National Biodefense Analysis and Countermeasures Center (NBACC) was recently
established as the first DHS laboratory specifically focused on biodefense. The mission
of the NBACC program is to understand current and future biological threats, assess
vulnerabilities and determine potential consequences, and provide a national capability
for conducting forensic analysis of evidence from bio-crimes and terrorism.7
Project BioShield. The private sector is reluctant to invest in the development of
drugs, vaccines and other medical countermeasures for threats such as bioterrorism that
may not materialize. To assure the availability of these products, the 108th Congress
launched Project BioShield to encourage the development of countermeasures that lack
commercial markets. To address problems with the program’s early implementation, the
109th Congress incorporated in Title IV of the PAHPA a requirement for the HHS
Secretary to develop and make public a strategic plan to guide HHS research,
development and procurement of countermeasures. The act also creates the Biodefense
Advanced Research and Development Authority (BARDA) in HHS, to help implement
the strategic plan, directly 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 creation and effectiveness of BARDA.8
Liability, Compensation, and Intellectual Property Issues. In December
2005, Congress passed Department of Defense Emergency Supplemental Appropriations,
2006 (P.L. 109-148). Division C of the law would eliminate liability, except in the case
of willful misconduct, for manufacturers and others involved in the production and use
of countermeasures, upon a declaration of emergency.9 In February 2007, HHS Secretary
5 See CRS Report RL33589.
6 Also, the Department of Defense conducts and funds research in, and the development of, the
relevant sciences, technologies, equipment, and systems to ensure that U.S. military forces are
able to detect, protect, treat and remediate against chemical and biological threats.
7 See CRS Report RL32891, The National Biodefense Analysis and Countermeasures Center:
Issues for Congress, by Dana A. Shea.
8 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.
9 See CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability
Limitation, by Henry Cohen and Vanessa K. Burrows.

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Leavitt made such a declaration with respect to pandemic flu vaccine.10 The law also
establishes a “Covered Countermeasure Process Fund,” and requires the HHS Secretary
to develop a compensation mechanism for those who may be injured by an indemnified
countermeasure. Two FY2007 supplemental appropriations bills (H.R. 1591 and P.L.
110-28) provided an appropriation to the Fund at various stages in the legislative process,
but in neither case was the provision enacted. 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.11
Workforce Surge Capacity. The health workforce is aging into retirement, yet
is strained by new homeland security duties. Authority for health professions programs
in HHS expired in 2002. These programs are primarily geared toward alleviating
shortages and maldistributions of primary care physicians and nurses. The public health
workforce has, in contrast, received little federal attention until recently. The PAHPA
authorizes a loan repayment demonstration project for individuals who serve in health
professional shortage areas, or areas at high risk of a public health emergency. Efforts to
increase the availability of health professionals for emergency response also include
ensuring civil liability protection for volunteer health professionals, and establishing a
system to verify the licenses and credentials of medical practitioners. While efforts are
ongoing among states and on the federal level, a uniform system for protection of
volunteer health professionals does not yet exist.12
Vulnerable Populations. The terror attacks of 2001 and hurricanes of 2005
showed that some people may be at greater risk of harm or more in need of special
services during and following a disaster. These may include persons with disabilities, as
defined by the Americans with Disabilities Act. Children and pregnant women may not
be able to safely use the same drugs as the general population during a bioterrorism
incident. Those living in poverty may have fewer options in complying with a mandatory
evacuation order. Those with mental health or substance abuse problems may worsen
when faced with disasters, or may lose access to services. The PAHPA requires the
Secretary of HHS, in various planning activities, to consider at-risk individuals, defined
as children, pregnant women, senior citizens, and others who have special needs in the
event of a public health emergency, as determined by the Secretary. The Post-Katrina Act
requires the head of FEMA to appoint a Disability Coordinator, who is charged, among
other things, with assessing the coordination of emergency management policies and
practices for individuals with disabilities, including training, physical and virtual access,
transportation, media outreach, and general coordination and dissemination of best
practices, including evacuation planning.13
10 72 Federal Register 4710-4711, February 1, 2007.
11 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.
12 See CRS Report RL32546, Title VII Health Professions Education and Training: Issues in
Reauthorization, by Bernice Reyes-Akinbileje (hereafter CRS Report RL32546); CRS Report
RS22255, Emergency Response: Civil Liability of Volunteer Health Professionals, by Kathleen
Swendiman and Nathan Brooks; and CRS Report RL33589.
13 See CRS Report RS22254, The Americans with Disabilities Act and Emergency Preparedness
(continued...)

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Pandemic Influenza Preparedness. The spread of avian influenza (“bird flu”)
and the human deaths it has caused raise concern that the virus could further evolve and
cause a global human pandemic. To prepare for this threat, 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 production capacity. In addition
to oversight of federal spending for pandemic flu, Congress may be interested in (1)
federal coordination of activities to prepare for and respond to a possible pandemic, such
as integrated surveillance for avian and human flu among HHS, DHS, the Departments
of Agriculture and Interior, the State Department, the U.S. Agency for International
Development, and the Defense Department; (2) the impact of avian flu on affected
countries; and (3) the possible effects of a flu pandemic on global trade and commerce.14
Rationing of Scarce Healthcare Resources. Health emergencies often
involve scarcities of healthcare and public health resources, including personnel,
equipment, drugs, and vaccines. Prioritizing the use of scarce 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.15
Isolation, Quarantine, and Mandatory Vaccination. 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 containment measures such as quarantine, isolation, and
mandatory vaccination, a comprehensive response to a public health emergency may
involve overlapping governmental authorities and attendant legal and economic issues.
Constitutional and federal statutory issues may also be raised where individual liberties
are restricted.16 Revised International Health Regulations, promulgated by the World
Health Organization (WHO), take effect upon signatory nations in June 2007, providing
guidance and requirements for, among other things, the management of infectious
diseases in international travelers.17
13 (...continued)
and Response, by Nancy Lee Jones; CRS Report RL33589; and CRS Report RL33729.
14 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 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, Emma Chanlett-Avery, Coordinator; and CRS Report
RS22453, Avian Flu Pandemic: Potential Impact of Trade Disruptions, by Danielle Langton.
15 For further discussion, see CRS Report RL33381, The Americans with Disabilities Act (ADA):
Allocation of Scarce Medical Resources During a Pandemic, by Nancy Lee Jones.
16 See CRS Report RL33201, Federal and State Quarantine and Isolation Authority, by Kathleen
S. Swendiman and Jennifer K. Elsea; 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.
17 For more information, see CRS Report RS22672, Extensively Drug-Resistant Tuberculosis
(continued...)

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Disaster Victims and Healthcare Costs. The 110th Congress may consider
ways to cover healthcare costs for disaster victims.18 Several bills in the 109th Congress
addressed the healthcare 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.19 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 impacted communities.20 Related issues include the healthcare, mental
health and substance abuse treatment needs of hurricane victims and efforts to rebuild
Louisiana’s devastated healthcare infrastructure. Crisis counseling programs to address
the mental health needs of the Hurricane Katrina victims may be extended. The Louisiana
Health Care Redesign Collaborative, a federal, state, local, and private partnership, has
been developed to propose options for rebuilding the healthcare system in southern
Louisiana through a Medicaid waiver and Medicare demonstration proposal.21
Expired and Expiring Authorities. The 110th Congress may consider
reauthorization of some expired or expiring preparedness and response programs.22 These
include the Select Agent Program, a program in HHS to regulate certain biological
pathogens and toxins that could be used for bioterrorism. Program authority expires 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
17 (...continued)
(XDR-TB): Quarantine and Isolation, by Kathleen S. Swendiman and Nancy Lee Jones.
18 See CRS Report RL33927, Selected Federal Compensation Programs for Physical Injury or
Death, by Sarah A. Lister, Edward Rappaport and C. Stephen Redhead; and “Federal Assistance
for Disaster-Related Healthcare Costs,” in CRS Report RL33579.
19 See, for example, S. 3918, S. 4021, S. 4022, H.R. 6046 and H.R. 6124. See also HHS, “World
Trade Center Health Resources,” at [http://www.hhs.gov/wtc/].
20 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.
21 See the Louisiana Healthcare Redesign Collaborative charter at [http://www.hhs.gov/
louisianahealth/collaborative/charter.html]; and 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. See,
also, CRS Report RL33579; CRS Report RL33083, Hurricane Katrina: Medicaid Issues, by
Evelyne P. Baumrucker, et al.; and CRS Report RL33738.
22 See Congressional Budget Office, “Unauthorized Appropriations and Expiring Authorizations,”
January 2007, at [http://www.cbo.gov/publications/bysubject.cfm?cat=6].
23 42 U.S.C. § 262a. See the CDC Select Agent Program page at [http://www.cdc.gov/od/sap/].
24 See CRS Report RL32546.
25 See CRS Report RL33589.

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