Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Congressional research reportMar 30, 2009

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Public Health and Medical Preparedness and

Response: Issues in the 111th Congress

name redacted

Specialist in Public Health and Epidemiology

March 30, 2009

Congressional Research Service

7-....

www.crs.gov

R40159

CRS Report for Congress

Prepared for Members and Committees of Congress

Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Summary

Key recent events—the 2001 terrorist attacks, Hurricane Katrina, and concerns about an influenza

(“flu”) pandemic, among others—sharpened congressional interest in the nation’s systems to

track and respond to public health threats. The 109th Congress passed several laws that

established, reorganized, or reauthorized key public health and medical preparedness and

response programs in the Departments of Health and Human Services (HHS) and Homeland

Security (DHS). The 110th Congress was engaged in oversight of the implementation of these

laws, focused in particular on such matters as (1) the fitness of HHS and DHS—in terms of

authority, funding, policies, and workforce—to respond to health emergencies; (2) the

effectiveness of coordination among them and other federal agencies; and (3) the status of major

initiatives such as pandemic flu preparedness and disaster planning for at-risk populations. The

111th Congress is likely to remain engaged in oversight of the nation’s readiness for health threats.

The Obama Administration may reconsider homeland security objectives and priorities

established by the George W. Bush Administration. Shifts in doctrine or priority, if any, may

manifest as key positions are filled, or in the budget proposal for FY2010.

The 111th Congress may review HHS’s disaster response capabilities, including its authority to

declare a public health emergency and the means to fund its response efforts. Among other things,

it is not clear that a flu pandemic would qualify for major disaster assistance under the Robert T.

Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act). Also, although the

HHS Secretary has authority for a no-year Public Health Emergency Fund, Congress has not

appropriated monies to the fund for many years. Finally, since Hurricane Katrina, Congress has

urged and HHS has adopted a more aggressive federal role in the response to health emergencies.

Historically, federal assistance to states in dealing with disasters has come mainly as guidance

and funding for preparedness and response activities. Since Hurricane Katrina, the federal role

has been more direct, involving, for example, more procurement and deployment of medical

response assets. Congress may wish to consider whether this trend is appropriate and sustainable.

At this time, there is no federal assistance program designed purposefully to cover the

uncompensated or uninsured health care costs for disaster victims. The 111th Congress may

reconsider earlier proposals to provide such assistance under certain circumstances.

Health emergencies often involve scarcities of resources (including personnel), movement

restrictions, business and school closures, and other constraints. While state and local

governments have the primary authority over such measures as quarantine and isolation, a

comprehensive response to a public health emergency may involve overlapping governmental

authorities and attendant legal and economic issues.

The 108th Congress launched Project BioShield to encourage the development of medical

countermeasures. Some concerns remain about the program’s ability to attract private-sector

developers. Also, the 109th Congress provided a means for liability protection for product

developers and others, if countermeasures are used during a health emergency. A program to

compensate persons who may be injured by such covered countermeasures has not been funded.

This report summarizes key issues in domestic public health and medical preparedness and

response, citing other CRS Reports and sources of additional information.

Congressional Research Service

Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Contents

Background ................................................................................................................................1

Key Legislation in Prior Congresses............................................................................................2

Issues for Congress .....................................................................................................................2

Government Leadership, Organization, and Capacity ............................................................2

The Presidential Transition..............................................................................................2

Executive Branch Organization .......................................................................................3

Federal Leadership and Coordination ..............................................................................3

Strategic Planning ...........................................................................................................4

HHS Response Capability and Funding Authority ...........................................................5

State Grants for Public Health and Health System Preparedness ......................................5

Economic Stimulus ...............................................................................................................6

Health System Preparedness and Response............................................................................6

Medical Surge Capacity ..................................................................................................6

Workforce Surge Capacity...............................................................................................8

The Health and Safety of Disaster Responders ................................................................8

Disaster Victims and Health Care Costs...........................................................................9

Medical Monitoring Following a Disaster .......................................................................9

Planning for the Needs of Special Populations..................................................................... 10

Defense Against Specific Threats ........................................................................................ 11

Pandemic Influenza Preparedness.................................................................................. 11

Communicable Disease Control .................................................................................... 12

Biodefense Laboratory Capacity and Oversight ............................................................. 13

Select Agent Program.................................................................................................... 13

Development, Procurement, and Use of Countermeasures ................................................... 14

Project BioShield .......................................................................................................... 14

Liability and Compensation .......................................................................................... 15

Expired Program Authorities ............................................................................................... 15

Contacts

Author Contact Information ...................................................................................................... 16

Congressional Research Service

Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Background

Three important principles color the issues in public health and medical preparedness and

response. First, preparedness and response are different functions. At each level of government,

they involve different leadership roles, legal authorities, organizational structures, and funding

mechanisms. Generally, during an incident, certain conditions must be met before a jurisdiction

can implement response activities, or access funds reserved for that purpose. Second, states and

localities, rather than the federal government, are the seats of authority and responsibility for the

oversight of both health care and emergency management. For example, state laws generally

authorize governors to order and enforce the evacuation of residents in emergency situations.

Except under extraordinary circumstances, the federal government generally does not dictate the

conduct of health care or emergency management activities to state or local officials, or to health

care providers.1 Finally, most public health functions—broad, population-based programs, such as

restaurant inspections to assure food safety—are inherently governmental. In contrast, the

nation’s health care system—which delivers professional health care services to individuals—is

primarily private and for-profit. Providers and facilities operate in an increasingly competitive

marketplace in which emergency planning is not always seen as a necessary expense.

The 2001 terrorist attacks, the flawed response to Hurricane Katrina, and concerns about an

influenza (“flu”) pandemic sharpened congressional interest in the nation’s ability to track and

respond to health threats. The 109th Congress established or reauthorized relevant programs and

activities in the Departments of Health and Human Services (HHS) and Homeland Security

(DHS). The 110th Congress focused on oversight of these activities, in particular (1) the fitness of

HHS and DHS—in terms of authority, funding, policies, and workforce—to respond to health

emergencies; (2) the effectiveness of federal agency coordination; and (3) the status of major

initiatives such as pandemic flu preparedness and disaster planning for at-risk populations.

The 111th Congress is likely to remain engaged in oversight of the nation’s readiness for health

threats. It faces a different and dynamic landscape, however. The Obama Administration will

likely usher in some shifts in preparedness priorities, in direction and degree yet to be shown. The

nation’s health care system is the subject of a vigorous reform debate. Although emergency

management is not the focus of that debate, significant system reforms, if enacted, would likely

affect emergency planning needs and system response capacity. And the nation’s unsettled

economy poses a dilemma for policy makers. Future spending for public programs may be

significantly constrained, unless a program were seen as a means for job creation, or some other

engine of economic stimulus. It remains to be seen where federal programs to address health

emergencies will fit into this complex picture.

This report, which will be updated as needed, summarizes key issues in domestic public health

and medical preparedness and response, citing other CRS Reports and sources of additional

information.

The federal government can, however, attach conditions to the expenditure of federal grant funds, in furtherance of

national goals.

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Key Legislation in Prior Congresses

The 109th Congress enacted two comprehensive laws affecting public health and medical

preparedness and response. The Pandemic and All-Hazards Preparedness Act (PAHPA, P.L. 109417), passed in 2006, established or extended programs for public health emergency preparedness

and response activities in HHS, and established a Biomedical Advanced Research and

Development Authority (BARDA) in HHS to oversee the development and procurement of

medical countermeasures (e.g., diagnostic tests, drugs, and vaccines).2 The Post-Katrina

Emergency Management Reform Act of 2006 (PKA, Title VI of P.L. 109-295) reorganized DHS

and, within it, the Federal Emergency Management Agency (FEMA). The PKA also codified the

position of DHS Chief Medical Officer, with primary responsibility within DHS for medical

issues related to natural and man-made disasters and terrorism.3

Issues for Congress

Government Leadership, Organization, and Capacity

The Presidential Transition

The Obama Administration may reconsider any number of homeland security objectives, and its

priorities are likely to differ, at least somewhat, from those of the George W. Bush

Administration. For example, the Bush Administration placed considerable emphasis on the

detection of and response to a large-scale biological attack. Among other things, it established the

BioWatch system of air monitors in major cities, and redirected federal funds from states to these

cities to bolster planning for mass dispensing of antibiotics in response to an attack. These efforts

were widely critiqued. Some said they were excessive, draining resources from routine public

health and biomedical research needs. Others said they were insufficient to protect the public in a

timely manner. Still others questioned the basic effectiveness of the programs. Critiques are likely

to continue, whether or not the Obama Administration maintains its predecessors’ priorities.

The transition also marks the first transfer of presidential authority for the Department of

Homeland Security (DHS), and for a number of homeland security positions and programs

established since 2001. These positions include the Assistant Secretary for Health Affairs and

Chief Medical Officer at DHS (DHS CMO),4 the Assistant Secretary for Preparedness and

Response (ASPR) in the Department of Health and Human Services (HHS), and their

corresponding offices and activities.

Shifts in doctrine or priority in the new Administration, if any, may manifest when key positions

are filled, or when the budget proposal for FY2010 is unveiled.

CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to

Preexisting Law, by (name redacted) and (name redacted).

P.L. 109-295, 120 Stat. 1409, 6 U.S.C. § 321e.

In the George W. Bush Administration, one individual served in this position with both titles.

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Executive Branch Organization

The 111th Congress may consider removing FEMA from DHS and re-establishing it as a separate

agency, as it was in the Clinton Administration. Other substantial reorganizations of federal

homeland security agencies do not appear to be under debate at this time. Congress may consider

relocating certain programs, however. (See, for example, the subsequent section “Select Agent

Program.”) Also, President Obama may consider reorganizing certain homeland security

functions, such as those of the Homeland Security Council (HSC). President George W. Bush

established the HSC in the Executive Office of the President shortly after the 2001 terrorist

attacks.5 From 2005 through 2008, the HSC served as the hub of federal preparedness activities

for pandemic flu, involving HHS, DHS, the State Department, and other federal departments and

agencies.6 Some have called for a merger of the HSC with the larger National Security Council

(NSC), citing a number of responsibilities shared by the two.7 It is reported that President Obama

has called for a comprehensive review of the functions of the NSC.8

Federal Leadership and Coordination

For public health and medical preparedness and response, the roles and responsibilities of

principals in HHS and DHS have shifted in past years. The 109th Congress provided some clarity,

but refinement of these roles and responsibilities is likely to continue for some time to come.

Pursuant to the PAHPA and the PKA, applicable activities in DHS are led by the DHS CMO, and

in HHS by the HHS ASPR. The PKA provided that the DHS CMO “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.... ”9 (Emphasis added.) Hence, the Secretary of Homeland Security leads all federal

emergency and disaster response activities; the DHS CMO leads both preparedness and response

activities for public health and medical care, but only within DHS; and the Secretary of HHS,

through the ASPR, leads all federal public health and medical response activities, under the

overall leadership of the Secretary of Homeland Security.

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.”10 GAO recommended that DHS and HHS conduct training and exercises to

ensure that federal leadership roles are clearly defined and understood. In February 2009, GAO

CRS Report RS22840, Organizing for Homeland Security: The Homeland Security Council Reconsidered, by (name r

edacted). The HSC was subsequently codifed in the Homeland Security Act, P.L. 107-296; 6 U.S.C. § 491 et seq.

See, for example, comments of Frances Fragos Townsend, Former Assistant to President George W. Bush for

Homeland Security and Counterterrorism, hearing of U.S. Congress, Senate Committee on Homeland Security and

Governmental Affairs, Structuring National Security and Homeland Security at the White House, 111th Cong., 1st sess.,

February 12, 2009.

See, for example, Rob Margetta, “Is HSC and its Chief Transitioning Out of the New Administration?,” CQ

Homeland Security, December 3, 2008. For more information about the NSC, see CRS Report RL30840, The National

Security Council: An Organizational Assessment, by (name redacted)

Karen DeYoung, “Obama’s NSC Will Get New Power,” Washington Post, February 8, 2009, p. A1.

P.L. 109-295, 120 Stat. 1409; P.L. 109-417, § 101, 120 Stat. 2832.

U.S. Government Accountability Office, Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership

Roles and Improve Pandemic Planning, GAO-07-1257T, September 26, 2007, http://www.gao.gov; and CRS Report

RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name redacted).

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

reported that although some recommended activities have been undertaken, it is unclear whether

these exercises rigorously tested federal leadership roles in a pandemic. 11

Federal incident response activities are coordinated according to the National Response

Framework (NRF), and “all-hazards” blueprint published by DHS.12 Public health and medical

response activities (under the leadership of HHS) are laid out in an annex called Emergency

Support Function #8, or ESF-8. These activities, at the federal, state, and local levels, are

commonly referred to as ESF-8 activities. The NRF replaced the earlier National Response Plan,

incorporating lessons from the flawed response to Hurricane Katrina. Nonetheless, some

leadership gaps and conflicts remain in ESF-8. In addition to the inter-related roles of the HHS

ASPR and the DHS CMO discussed above, there are concerns about a lack of leadership clarity

for responder health and safety (see “The Health and Safety of Disaster Responders”); emergency

sheltering; mass fatality management; and mental health services, among others.13

On January 28, 2009, DHS Secretary Janet Napolitano announced an action directive to review

the Department’s plans for the response to a large-scale medical incident.14 The directive required

specific DHS offices and components, working with state and local partners, to review and assess

current plans (including ESF-8 in the NRF), relevant homeland security grant programs, and

other matters. DHS components were to report to the Secretary by February 24, 2009.

Strategic Planning

The PAHPA requires the HHS Secretary to publish a comprehensive, all-hazards national public

health and medical response strategy and implementation plan (the “National Health Security

Strategy,” or NHSS), beginning in 2009, and quadrennially thereafter.15 The NHSS is to include a

process for achieving a number of preparedness goals enumerated in the statute. In 2007, the

Bush Administration published a homeland security directive to establish a “national strategy for

public health and medical preparedness,” including implementation steps.16 The directive stated

that the principles and actions it contained were to be incorporated into the NHSS, and serve as a

foundation to address the preparedness goals prescribed by the PAHPA.

On September 30, 2008, the Office of the HHS ASPR awarded a delivery order (a type of

contracting mechanism) to the RAND Corporation, to provide support in developing the NHSS

during FY2009.17 The 111th Congress may be interested in monitoring the NHSS development

U.S. Government Accountability Office, Influenza Pandemic: Sustaining Focus on the Nation’s Planning and

Preparedness Efforts, GAO-09-334, February 26, 2009, http://www.gao.gov.

Department of Homeland Security, National Response Framework, Washington, DC, January 2008,

http://www.fema.gov/emergency/nrf/. See also CRS Report RL34758, The National Response Framework: Overview

and Possible Issues for Congress, by (name redacted).

For more information, see “Unclear Federal Leadership for Certain Response Functions,” in CRS Report RL33579,

The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name redacted).

Department of Homeland Security, “Secretary Napolitano Issues Action Directives on First Responder Health Surge

Capacity and Hurricane Katrina,” press release, January 28, 2009, http://www.dhs.gov/ynews/releases.

CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to

Preexisting Law, by (name redacted) and (name redacted).

President George W. Bush, Homeland Security Presidential Directive 21, Public Health and Medical Preparedness,

Washington, DC, October 18, 2007.

General Services Administration, Federal Procurement Data System, contract transaction #18599705, September 30,

2008.

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

process, in particular whether the leadership of the Office of the HHS ASPR maintains steady

progress toward completion during the Obama Administration, and the extent to which the

strategy and its accompanying plans and goals reflect, or are consistent with, any changes in

doctrine or priority that may be adopted by the new Administration.

HHS Response Capability and Funding Authority

The 111th 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 and

the expanded authorities that flow from it.18 Members of Congress may also consider how HHS

funds any of its disaster response activities that are not reimbursable by FEMA. Although the

HHS Secretary has authority for a no-year Public Health Emergency Fund, Congress has not

appropriated monies to the fund for many years. Also, it is not clear that a flu pandemic would

qualify as a major disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance

Act (the Stafford Act). The definition of major disaster in the law does not explicitly include or

exclude infectious diseases, and past interpretations of the provision’s applicability to

bioterrorism and naturally occurring infectious diseases have varied. If major disaster assistance

were applicable in a flu pandemic, substantial FEMA funds could be available to support HHS

response activities. 19

State Grants for Public Health and Health System 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.20 The Cooperative Agreement for Public

Health Emergency Preparedness is administered by the Centers for Disease Control and

Prevention (CDC).21 The Hospital Preparedness Program is administered by the HHS ASPR.22

The programs have been challenging for federal managers and state awardees alike. Among other

things, federal managers have had difficulty developing meaningful and measurable performance

goals for the programs.23 Also, state awardees have had some difficulty staffing their

preparedness programs. Some have cited, as explanations, public health workforce shortages, and

the challenges of recruiting with annual discretionary or “soft” funding. 24

CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by

(name redacted). See, also, HHS, “Department of Health and Human Services Secretarial Declaration of a Public Heath

Emergency,” http://www.hhs.gov/disasters/discussion/planners/section319declaration.html.

CRS Report RL34724, Would an Influenza Pandemic Qualify as a Major Disaster Under the Stafford Act?, by

(name redacted).

CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to

Preexisting Law, by (name redacted) and (name redacted).

See http://emergency.cdc.gov/cotper/coopagreement/.

See http://www.hhs.gov/aspr/opeo/hpp/index.html.

See, for example, Christopher D. Nelson, Ellen Burke Beckjord, and David J. Dausey, et al., “How Can We

Strengthen the Evidence Base in Public Health Preparedness?,” Disaster Medicine and Public Health Preparedness,

vol. 2, no. 4 (December 2008), pp. 247-250; and Nicole Lurie, Jeffrey Wasserman, and Christopher D. Nelson, “Public

Health Preparedness: Evolution Or Revolution?,” Health Affairs, vol. 25, no. 4 (July/August 2006), pp. 935-945.

See Association of State and Territorial Health Officials, States of Preparedness: Health Agency Progress, Second

(continued...)

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Economic Stimulus

In February 2009, Congress passed and the President signed P.L. 111-5, the American Recovery

and Reinvestment Act of 2009 (ARRA), a package of spending and tax cuts intended to stimulate

the nation’s flagging economy. The law provided $50 million for cyber-security improvements at

HHS. Earlier versions of the legislation would also have provided (1) $430 million for the

advanced development and procurement of medical countermeasures through the Biomedical

Advanced Research and Development Authority (BARDA);25 and (2) $420 million for pandemic

flu preparedness for facility construction and the development and/or purchase of vaccines, drugs,

supplies, and equipment. The BARDA and pandemic provisions were removed in conference. 26

The law did not include enhanced funding for the CDC or HHS/ASPR public health or hospital

preparedness grants to states, discussed earlier.27

Health System Preparedness and Response

Medical Surge Capacity

Policymakers have long been concerned about medical surge capacity, that is, the ability of health

systems to manage large increases in caseloads that would result from mass casualty incidents.

The successful response to such incidents requires the coordination of several elements, which are

variously based in federal, state or local authority, or in the private sector. These elements are (1)

patients, who may require rescue or medical evacuation; (2) a treatment facility, which may be an

existing hospital, or a field tent with cots; (3) a competent health care workforce; (4) medical

equipment and non-perishable medical supplies; (5) drugs, vaccines, tests and other perishable

medical supplies; (6) a system of medical records; and (7) a health care financing mechanism.

Facing growing cost constraints for several decades, the largely private health care sector has

sought to avoid having the unused, reserve capacity (such as empty beds) that would be needed in

such situations. Since 2001, the federal government has sought to establish this capacity in the

private sector, with mixed success. For example, the HHS Hospital Preparedness Program

(described above) makes grants to state governments to work with private health care facilities

and systems in assuring regional surge capacity, but the effectiveness of the program has been

questioned. 28

(...continued)

Edition, Washington, DC, September 2008, http://www.astho.org/pubs/StatesofPreparedness2008fin.pdf; and U.S.

Government Accountability Office, Public Health and Hospital Emergency Preparedness Programs: Evolution of

Performance Measurement Systems to Measure Progress, GAO-07-485R, March 23, 2007, http://www.gao.gov.

BARDA is in the Office of HHS/ASPR and is discussed in a subsequent section of this report, “Project BioShield”.

Subsequent to the passage of ARRA, Congress passed and the President signed P.L. 111-8, the Omnibus

Appropriations Act, 2009, which provided funding for BARDA and pandemic flu, partly through transfers from an

earlier FY2004 appropriation to the Department of Homeland Security for Project BioShield.

For more information, see CRS Report R40181, Selected Health Funding in the American Recovery and

Reinvestment Act of 2009, coordinated by (name redacted).

See, for example, Eileen Salinsky, Strong as the Weakest Link: Medical Response to a Catastrophic Event, National

Health Policy Forum, Background Paper No. 65, Washington, DC, August 8, 2008, http://www.nhpf.org/library/

details.cfm/2640; U.S. Government Accountability Office, Emergency Preparedness: States Are Planning for Medical

Surge, but Could Benefit from Shared Guidance for Allocating Scarce Medical Resources, GAO-08-668, June 13,

2008, http://www.gao.gov; and Amy H. Kaji, Kristi L. Koenig, and Roger J. Lewis, “Current Hospital Disaster

(continued...)

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Historically, the federal government has helped states with disaster response primarily by

providing guidance and funding for preparedness activities, and assisting with the costs of

response activities. During Hurricane Katrina, the shortcomings of this approach with respect to

medical surge capacity were evident. Since then there has been an expansion of the federal role

through direct procurement and deployment of medical response assets, providing a stronger

backstop for state, local, and private-sector response efforts. For example, the PAHPA authorized

HHS to acquire mobile medical assets, such as Field Medical Stations (FMS).29

HHS assets and personnel were deployed extensively for the evacuation and care of individuals

with special needs before and during Hurricanes Gustav and Ike in the Fall of 2008.30 The

Strategic National Stockpile (SNS) of medical supplies and drugs, as well as the National Disaster

Medical System and other programs to provide emergency health workers, have also been

expanded since 2005.31 The costs to procure FMS and SNS assets are borne in annual

discretionary appropriations and may be fairly easily tracked. In contrast, many of the costs to

deploy these and other assets in a disaster response, in addition to the staffing costs required to

support these deployments, are often reimbursed by FEMA from the Disaster Relief Fund.32 The

federal government has not published information about the costs associated with HHS’s

responses to Hurricanes Gustav and Ike. The Congress may be interested in seeking information

about these costs, in order to determine whether they represent an appropriate and sustainable

investment of federal effort.

Finally, the 111th Congress may examine the performance of the federal Crisis Counseling

Assistance and Training Program (CCP), which is authorized in the Stafford Act and administered

jointly by HHS, FEMA, and the states to address mental health problems among disaster

victims.33 The response to Hurricane Katrina in 2005 prompted a re-examination of the CCP and

other federal assistance programs that address disaster mental health. Concerns include the lack of

a sound evidence base to identify effective services, the timeliness of services provided, the

appropriate scope and duration of these services, and matters of organization, cost, and

accountability. For example, the respective roles and responsibilities of HHS (which provides

technical expertise for state CCP programs through its Substance Abuse and Mental Health

Services Administration), FEMA (which funds the state programs), and states and their

contractors (which implement them) are not always clear.

(...continued)

Preparedness,” JAMA, vol. 298 (November 14, 2007), pp. 2188-2190.

CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to

Preexisting Law, by (name redacted) and (name redacted).

HHS: “HHS Supports Medical Evacuations in Preparation for Hurricane Gustav,” press release, August 31, 2008;

and “HHS Provides State Assistance in Preparing for Hurricane Ike, Recovering from Hurricane Gustav,” press release,

September 11, 2008, http://www.hhs.gov/news.

See HHS, “Federal Public Health and Medical Assistance,”

http://www.hhs.gov/disasters/discussion/planners/medicalassistance.html.

CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and Funding, by

(name redacted).

CRS Report RL33738, Gulf Coast Hurricanes: Addressing Survivors’ Mental Health and Substance Abuse

Treatment Needs, by (name redacted), (name redacted), and (name redacted).

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Workforce Surge Capacity

The HHS Health Resources and Services Administration (HRSA) manages several health

professions programs intended to alleviate shortages and maldistributions of physicians, nurses,

and others who provide health care services to individuals.34 These programs are not, however,

geared toward assuring disaster surge capacity in the health care workforce. Efforts to bolster the

ranks of health professionals for disaster response include ensuring civil liability protection for

volunteer health professionals, and establishing a national 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.35

Surge capacity in the public health workforce—those workers who assure safe food and water,

conduct diseases surveillance, and carry out other public health activities in response to

disasters—has 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, but the authority has not been implemented.36

At this time, the National Disaster Medical System, administered by the HHS ASPR,37 and the

Medical Reserve Corps, administered by local governments with the assistance of the HHS Office

of the Surgeon General,38 provide surge capacity to bolster the local disaster response workforce

in both health care and public health.

The Health and Safety of Disaster Responders

Responsibility for the health and safety of disaster response workers is a matter of concern in the

National Response Framework (NRF). GAO found that the efforts of the Occupational Safety and

Health Administration (OSHA, in the Department of Labor) during the response to Hurricane

Katrina were hampered by confusion about OSHA’s role. GAO noted in particular that

disagreements between FEMA and OSHA regarding OSHA’s role delayed FEMA’s authorization

of mission assignments to fund OSHA’s response activities.39 Some Members of Congress and

others sought to have worker health and safety elevated from a Support Annex to an Emergency

Support Function in the NRF, which would have given OSHA more autonomy in commencing its

response activities. 40 Instead, the NRF contains a revised Worker Safety and Health Support

Annex. 41

See, for example, CRS Report RL32546, Title VII Health Professions Education and Training: Issues in

Reauthorization, by (name redacted); and CRS Report RL32805,

Nursing Workforce Programs in Title VIII

of the Public Health Service Act, by (name redacted).

CRS Report R40176, Emergency Response: Civil Liability of Volunteer Health Professionals, by (name redacted).

CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to

Preexisting Law, by (name redacted) and (name redacted).

HHS, National Disaster Medical System, http://www.hhs.gov/aspr/opeo/ndms/index.html.

HHS, About the Medical Reserve Corps, http://www.medicalreservecorps.gov/About.

U.S. Government Accountability Office, Disaster Preparedness: Better Planning Would Improve OSHA’s Efforts to

Protect Workers’ Safety and Health in Disasters, GAO-07-193, March 28, 2007, http://www.gao.gov.

Katherine Torres, “DHS Denies OSHA Power to Invoke Emergency Response Plan, Official Says,” Occupational

Hazards, vol. 70 (March 1, 2008); and “Despite Lawmakers’ Concerns, OSHA’s Role in NRF Remains Unchanged,”

Inside OSHA, February 4, 2008.

NRF, Worker Safety and Health Support Annex, http://www.fema.gov/emergency/nrf/.

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Disaster Victims and Health Care Costs

There is no federal assistance program designed purposefully to cover the uncompensated or

uninsured costs of individual health care that may be needed as a result of a disaster.42 There is

not consensus that this should be a federal responsibility. Nonetheless, if faced with a mass

casualty incident, hospitals, physicians, and other providers could face considerable pressure to

deliver care without a clear source of reimbursement.

Congress or the Bush Administration provided special assistance to address this concern three

times in response to recent disasters. Following the September 11, 2001 terrorist attacks, HHS

provided funding to hospitals, clinics, and other health care facilities (including privately owned

facilities) near the three affected sites (in NY, PA, and VA), that either provided unreimbursed

health care services to victims, or suffered other economic hardship as a result of road closures or

other infrastructure effects.43 Through intermittent appropriations, Congress has funded a program

to provide medical screening, monitoring, and treatment services to responders and others who

were exposed to hazards at the World Trade Center site in NY following the 2001 terrorist attack,

and who are now experiencing health problems that are believed to have resulted from those

exposures. 44 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.45

Legislative proposals in the 110th Congress would have: authorized the HHS Secretary to use a

special fund to provide temporary emergency health care coverage for uninsured individuals

affected by public health emergencies (H.R. 6569/S. 3312); or addressed the health care needs of

responders and others who are ill purportedly as a result of exposures at World Trade Center

(WTC) site in NY following the 2001 terrorist attack (for example, H.R. 1414/ S. 201, S. 1119,

H.R. 1247, H.R. 3543, H.R. 6594, and H.R. 7174). None of these proposals was enacted. H.R.

847, the James Zadroga 9/11 Health and Compensation Act of 2009, has been introduced in the

111th Congress to address WTC-related illnesses.

Medical Monitoring Following a Disaster

After the 2001 terrorist attack on the World Trade Center, some responders developed chronic

health problems believed to have resulted from hazardous exposures during the rescue, recovery,

and clean-up operations.46 Efforts to track and address these problems were hampered because, at

For more information, see “Federal Assistance for Disaster-Related Health Care Costs,” in CRS Report RL33579,

The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name redacted); and CRS

Report RL33927, Selected Federal Compensation Programs for Physical Injury or Death, (name redacted) and (na

me redacted), Coordinators.

See HHS, “Emergency Awards for Healthcare Under Section 319 of the PHS Act Grants for Immediate Response,”

67 Federal Register 15206-15208, March 29, 2002, the second of two notices of availability of funds. HHS invoked the

public health emergency authority in Section 319 of the Public Health Service Act to support its action.

For more information, see “World Trade Center Medical Monitoring and Treatment Program,” in CRS Report

RL33927, Selected Federal Compensation Programs for Physical Injury or Death, coordinated by (name redacted).

U.S. Government Accountability Office, Hurricane Katrina: Allocation and Use of $2 Billion for Medicaid and

Other Health Care Needs, GAO-07-67, February 28, 2007, http://www.gao.gov.

For more information, see “World Trade Center Medical Monitoring and Treatment Program,” in CRS Report

RL33927, Selected Federal Compensation Programs for Physical Injury or Death, (name redacted) and (name redac

ted), Coordinators.

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the outset, no central registry was established to identify all responders and other on-site workers,

and no program was established to monitor their health going forward, in order to quickly detect

common or unusual illness patterns in the cohort.

Following Hurricane Katrina, the 109th Congress enacted the SAFE Port Act (P.L. 109-347). One

of its provisions authorizes the President, acting through the Secretary of HHS and pursuant to a

major disaster declaration under the Stafford Act, to establish medical monitoring programs, if

needed, to track the health status of individuals (not limited to responders) who may experience

hazardous exposures as a result of the disaster. 47 The authority has not yet been implemented.

According to GAO, as of May 2008, HHS had not articulated a plan for doing so. 48 Federal

agency responsibilities and funding mechanisms are not clear without such a plan. For example,

within HHS, at least three components—the ASPR, as well as the Agency for Toxic Substances

and Disease Registry and the National Institute for Occupational Safety and Health, both in

CDC—have relevant authorities and responsibilities that overlap. Also, a major disaster typically

triggers federal coordinating mechanisms laid out in the NRF, which places OSHA in the lead in

assuring responder health and safety.49 In 2008 GAO recommended, for future disasters, that

HHS develop plans to register all responders during a disaster, as part of a comprehensive

departmental plan to assure responder health during and after disasters.50 GAO said that such a

plan should also include a means to implement medical monitoring programs, or to assist states

and localities in doing so. To meet the intent of the SAFE Port Act, such a plan must also address

affected individuals who are not responders.

Planning for the Needs of Special 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 after a disaster.51 The PAHPA requires

the Secretary of HHS to consider, in emergency 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.52 The 110th Congress authorized and appropriated funds for a National Commission

on Children and Disasters, which has been established in the HHS Administration for Children

and Families. 53

The Security and Accountability For Every (SAFE) Port Act, P.L. 109-347, § 709, 120 Stat. 1947, Oct. 13, 2006.

U.S. Government Accountability Office, HHS Needs to Develop a Plan That Incorporates Lessons from the

Responder Health Programs, GAO-08-610, May 30, 2008, http://www.gao.gov.

For more information, see “Unclear Federal Leadership for Certain Response Functions,” in CRS Report RL33579,

The Public Health and Medical Response to Disasters: Federal Authority and Funding, by (name redacted).

U.S. Government Accountability Office, September 11: HHS Needs to Develop a Plan That Incorporates Lessons

from the Responder Health Programs, GAO-08-610, May 30, 2008, http://www.gao.gov.

Shortly before the 2005 hurricanes, the National Council on Disability issued a major report on emergency

preparedness and individuals with disabilities. National Council on Disability, Saving Lives: Including People with

Disabilities in Emergency Planning, Washington, DC, April 15, 2005, http://www.ncd.gov/newsroom/publications/

2005/pdf/saving_lives.pdf.

CRS Report RS22254, The Americans with Disabilities Act and Emergency Preparedness and Response, by (name

redacted).

P.L. 110-161, the FY2008 Consolidated Appropriations Act, Division G, Title V, 121 Stat. 2213-2217; and HHS

Administration for Children and Families, “Notification of the Establishment of the National Commission on Children

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The 111th Congress is likely to be interested in the continued evolution of these efforts, in

particular, how well these federal efforts address the diversity of special needs that exist in the

population, and how well they are coordinated with each other in planning, and during disaster

response. GAO has commented, for example, that the Office of the FEMA Disability Coordinator

has generally not coordinated its work with a key federal agency—the National Council on

Disability—as it is required to do by the PKA. 54

Defense Against Specific Threats

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 FY2006.55 Most of it has supported an HHS initiative to

expand domestic vaccine production capacity.56 The Congressional Budget Office (CBO) has

analyzed the uncertainties and financial risks associated with this robust investment in applied

research and infrastructure development, noting that the success of the HHS initiative may be

affected, among other things, by the outcomes of research efforts to improve vaccine technology,

and the extent to which the demand for seasonal flu vaccine can sustain the costs of expanded

production capacity and more sophisticated vaccine production technology over the long term. 57

GAO has made a number of recommendations regarding pandemic response planning,

coordination, and capacity in recent years, and reported in February 2009 that many of the

recommendations had not yet been fully implemented. 58

Given the considerable federal investment in preparing for this threat, the 111th Congress is likely

to remain interested in the status of national preparedness efforts. Additional issues of potential

interest may include (1) the priority given by the Obama Administration to continued planning

efforts, including its budget request for FY2010; (2) future federal leadership for planning efforts

(see the earlier discussion of the HSC in the section “Executive Branch Organization”); and (3)

the status of state preparedness efforts.59 Finally, as mentioned earlier, it is not clear that a flu

(...continued)

and Disasters,” 73 Federal Register 51489-51490, September 3, 2008. See also, the section “Children and Disasters” in

CRS Report RL34758, The National Response Framework: Overview and Possible Issues for Congress, by (name red

acted).

U.S. Government Accountability Office, National Disaster Response: FEMA Should Take Action to Improve

Capacity and Coordination between Government and Voluntary Sectors, GAO-08-369, February 27, 2008,

http://www.gao.gov.

CRS Report RS22576, Pandemic Influenza: Appropriations for Public Health Preparedness and Response, by (name

redacted); and CRS Report RL33145, Pandemic Influenza: Domestic Preparedness Efforts, by (name redacted).

For more information, see HHS Pandemic Planning Updates I through VI, March 2006 through January 2009,

http://www.pandemicflu.gov/plan/federal/index.html.

Congressional Budget Office, U.S. Policy Regarding Pandemic-Influenza Vaccines, Washington, DC, September

2008, http://www.cbo.gov/doc.cfm?index=9573.

U.S. Government Accountability Office, Influenza Pandemic: Sustaining Focus on the Nation’s Planning and

Preparedness Efforts, GAO-09-334, February 26, 2009, http://www.gao.gov.

See HHS, Assessment of States’ Operating Plans to Combat Pandemic Influenza, HHS Report to the Homeland

Security Council, Washington, DC, January 2009, http://www.pandemicflu.gov/plan/states/index.html; and CRS

Report RL34190, Pandemic Influenza: An Analysis of State Preparedness and Response Plans, by (name redacted) and

(name redacted).

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

pandemic would qualify as a major disaster under the Stafford Act.60 If so, substantial FEMA

funds could be made available for HHS response activities. If not, alternative funding options

available to the Secretary of HHS are limited. (See the earlier section of this report, “HHS

Response Capability and Funding Authority.”)

Communicable Disease Control

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. 61

Managing employers’ and workers’ concerns during outbreaks of communicable disease—in

particular, a flu pandemic—may be especially difficult. For example, if workers fear losing their

employment or their wages, compliance with public health measures such as isolation or

quarantine may suffer. Although public health officials typically recommend, whenever possible,

that isolation or quarantine measures be voluntary rather than compulsory, voluntary measures

may not provide the same level of job protection for workers who miss work in order to comply

with them. 62

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.63 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.

Finally, 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.64

CRS Report RL34724, Would an Influenza Pandemic Qualify as a Major Disaster Under the Stafford Act?, by

(name redacted).

CRS Report RL33201, Federal and State Quarantine and Isolation Authority, by (name redacted) and

(name redacted); CRS Report RS22219, The Americans with Disabilities Act (ADA) Coverage of Contagious

Diseases, by (name redacted); and CRS Report RS21414, Mandatory Vaccinations: Precedent and Current Laws, by

(name redacted).

CRS Report RL33609, Quarantine and Isolation: Selected Legal Issues Relating to Employment, by (name reda

cted) and (name redacted).

CRS Report RL34144, Extensively Drug-Resistant Tuberculosis (XDR-TB): Emerging Public Health Threats and

Quarantine and Isolation, by (name redacted) and (name redacted).

CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During

a Pandemic, by (name redacted).

Congressional Research Service

Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Biodefense Laboratory Capacity and Oversight

Since 2001, HHS, DHS, USDA, the Department of Defense (DOD), state governments, and some

academic institutions have expanded or are expanding their laboratory capacity to study or test for

dangerous biological pathogens and toxins. These laboratories play a key role in the biodefense

effort, offering the hope of better responses to a biological attack and a better understanding of

the bioterrorism threat. However, they could also increase the risk of a biological attack by being

a source of materials or training. In 2008, the congressionally mandated Commission on the

Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommended, among

other things, the expansion of government oversight of these laboratories.65

The 111th Congress may consider issues associated with domestic biodefense laboratories, such as

the effectiveness of current oversight efforts, the appropriate balance between security and the

transparency that fosters scientific discovery, and possible effects of domestic regulatory

approaches on international collaboration.66 Legislation introduced in the 111th Congress (S.

485/H.R. 1225)67 would require the HHS Secretary to review and report to Congress regarding,

among other things, the adequacy of current and planned laboratory capacity, and information

sharing between the biodefense and infectious disease communities. The Secretary would also be

required to develop minimal training standards for personnel, and to establish a voluntary

reporting system through which laboratory personnel could report accidents and other incidents.

Select Agent Program

Legislation introduced in the 111th Congress (S. 485/H.R. 1225) would reauthorize the Select

Agent Program, which is jointly managed by the CDC and the U.S Department of Agriculture

(USDA) Animal and Plant Health Inspection Service (APHIS) to regulate certain biological

pathogens and toxins that could be used for bioterrorism. 68 Program authority expired at the end

of FY2007. The bills would require, among other things, a program review, planning for surges in

testing capacity, and guidance to improve inventory practices. They would also authorize HHS

and USDA to release certain sensitive information about the program to designated state officials

if a state’s laws are adequate to protect against the further release of such information. The bills

would leave program administration under CDC and APHIS, as it is now.

In August 2008, the Federal Bureau of Investigation (FBI) announced that it believed a DOD

scientist had been responsible for the 2001 anthrax attacks.69 The individual took his own life

before charges could be filed, so the case will not reach a legal conclusion. Nonetheless, the

incident has heightened concerns about the effectiveness of security risk assessments

Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, World At Risk: The

Report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, New York,

NY, December 2008, pp. 27-32, http://www.preventwmd.gov/home/.

CRS Report R40418, Oversight of High-Containment Biological Laboratories: Issues for Congress, by (name

redacted) and (name redacted).

Laboratory oversight provisions are found in Title II of these bills. Provisions to reauthorize the Select Agent

programs, discussed in the next section of this report, are found in Title I of these bills.

42 U.S.C. § 262a and 7 U.S.C. § 8401. See CDC Select Agent Program, http://www.cdc.gov/od/sap/, and APHIS

Agricultural Select Agent Program, http://www.aphis.usda.gov/programs/ag_selectagent/.

Federal Bureau of Investigation, “Anthrax Investigation: Closing a Chapter,” August 6, 2008,

http://www.fbi.gov/page2/august08/amerithrax080608a.html.

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

(“background checks”) that FBI conducts on individuals who are registered in the Select Agent

Program and granted access to the pathogens. Subsequently, the Commission on the Prevention of

Weapons of Mass Destruction Proliferation and Terrorism—which was mandated by Congress

before the matter involving the anthrax scientist was publicly known—recommended a

comprehensive review of the Select Agent Program. 70

The Commission did not recommend that leadership for the Select Agent Program be changed.

However, at a hearing on the Commission’s report, Senators Joseph Lieberman and Susan Collins

(the Chairman and Ranking Member, respectively, of the Senate Committee on Homeland

Security and Governmental Affairs) signaled that they may introduce legislation to put DHS in

charge of regulating biological pathogens. 71 CDC and APHIS have the scientific and technical

expertise to support the program, but the Senators were concerned that they may lack the

homeland security and national security expertise that is also required. However, some members

of the biomedical research community were concerned about proposals to move the program into

DHS when legislation to establish the new department was under consideration in 2002.72 They

argued, successfully at the time, that the program should remain with CDC and APHIS.

Development, Procurement, and Use of Countermeasures

Project BioShield

The 108th Congress launched Project BioShield to encourage the development of

countermeasures that lack commercial markets. (The program is not limited to procurement of

biodefense countermeasures. Products to address radiological, chemical, and other threats are also

considered.) DHS and HHS have shared responsibility for the program since its inception,

although the process by which procurement decisions are made has changed several times.73 At

this time, DHS manages a 10-year advance appropriation (through FY2013) to purchase

countermeasures, and is responsible for conducting Material Threat Determinations (MTDs) to

assess whether a particular hazard—such as an anthrax or sarin gas attack—poses a threat to

national security. In response to an MTD, HHS evaluates the threat, and the potential need for

countermeasures, in a public health context. Funds for development and procurement are drawn

from the 10-year appropriation, with the approval of the President, following joint

recommendations from the Secretaries of HHS and DHS.

The 109th Congress established, in the PAHPA, the Biomedical Advanced Research and

Development Authority (BARDA) in HHS to support countermeasure development and facilitate

communication between the government and developers. The PAHPA also required the HHS

Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, World At Risk: The

Report of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, New York,

NY, December 2008, pp. 27-32, http://www.preventwmd.gov/home/.

U.S. Congress, Senate Committee on Homeland Security and Governmental Affairs, Prevention of Weapons of Mass

Destruction Proliferation and Terrorism, 110th Cong., 2nd sess., December 11, 2008. See also Matthew M. Johnson,

“Lieberman to Seek Tougher Regulations for Biological Research Labs,” CQ Homeland Security, December 11, 2008.

See, for example, testimony of the American Society for Microbiology, U.S. Congress, House Committee on Energy

and Commerce, Subcommittee on Oversight and Investigations, hearing on Creating the Department of Homeland

Security: Consideration of the Administration’s Proposal, 107th Cong., 2nd sess., June 25, 2002.

CRS Report RL33907, Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for

Congress, by (name redacted).

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Secretary to develop and publish a strategic plan to guide HHS countermeasures research,

development, and procurement.74

The BioShield program has experienced numerous problems over the years, and many have been

resolved. 75 Key issues that remain are (1) the clarity of the shared roles of DHS and HHS; and (2)

whether HHS can define contract terms that are perceived by product developers as sufficiently

clear and lucrative to be worth their investment. The first concern appears to have improved over

time, partly as a result of successive directives from Congress and the Bush Administration.

Given the program’s limited history of successful procurements, the second concern may persist

and continue to be of interest to the 111th Congress.

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.76

Liability and Compensation

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, distribution, and use of covered countermeasures. 77 In October 2008,

HHS Secretary Leavitt made several such emergency declarations with respect to

countermeasures for smallpox, anthrax, botulism, and acute radiation sickness, and amended a

prior declaration for pandemic flu countermeasures. 78 Each declaration is in effect through 2016,

unless amended.

The law also establishes, in the U.S. Treasury, a “Covered Countermeasure Process Fund” to

compensate those who may be harmed by a covered countermeasure. As of FY2009, the fund has

not received an appropriation. No funding was requested in the annual budget submissions of the

Bush Administration.

Expired Program Authorities

The 111th Congress may consider reauthorization of expired preparedness and response

programs. 79 These include authority for HHS health professions programs, which expired in 2002.

In July, 2007, HHS published a draft plan. It has not been finalized. See HHS, Biomedical Advanced Research and

Development Authority (BARDA), Draft BARDA Strategic Plan for Medical Countermeasure Research, Development,

and Procurement, Washington, DC, July 5, 2007, http://www.hhs.gov/aspr/barda/documents/draftbardaplan.pdf.

See, for example, U.S. Government Accountability Office, Project Bioshield: Actions Needed to Avoid Repeating

Past Mistakes, GAO-08-208T, October 23, 2007, http://www.gao.gov.

CRS Report RL32917, Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security, by

(name redacted) and (name redacted); and CRS Report RL33159, Influenza Antiviral Drugs and Patent Law Issues,

by (name redacted).

CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation, by (name redacted)

and (name redacted).

Office of the Secretary, Department of Health and Human Services, 73 Federal Register 58239, October 6, 2008; and

73 Federal Register 61861-61873, October 17, 2008.

An inventory of expired and expiring authorities, organized by congressional committees of jurisdiction, is provided

(continued...)

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Public Health and Medical Preparedness and Response: Issues in the 111th Congress

These programs, in Title VII of the Public Health Service Act, aim to address underserved areas

and populations, and have not focused on emergency preparedness and response in the past.

However, the last reauthorization in 1998 preceded heightened concerns regarding this matter

since 2001.80 Also, although authority for the Strategic National Stockpile of countermeasures

was amended since the terror attacks of 2001, general program authority expired at the end of

FY2006 and has not been extended. 81 In addition, as discussed earlier, authority for the Select

Agent program to regulate biological pathogens expired at the end of FY2007.

Author Contact Information

(name redacted)

Specialist in Public Health and Epidemiology

[redacted]@crs.loc.gov, 7-....

(...continued)

in Congressional Budget Office, Unauthorized Appropriations and Expiring Authorizations, Washington, DC, January

2009, http://www.cbo.gov/doc.cfm?index=9960.

CRS Report RL32546, Title VII Health Professions Education and Training: Issues in Reauthorization, by (name re

dacted).

Public Health Service Act § 319F-2; 42 U.S.C. § 247d-6b. See CRS Report RL33589, The Pandemic and AllHazards Preparedness Act (P.L. 109-417): Provisions and Changes to Preexisting Law, by (name redacted) and (name

redacted), for amendment to the program by the PAHPA.

Congressional Research Service

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