Biodefense and Homeland Security Technology Development:

Biodefense and Homeland Security
Technology Development:
Analysis of U.S. Policies and Process of
Selection
David Clifford and Nicholas S. Vonortas
Center for International Science and Technology Policy
The George Washington University
Report
To
International Access Corporation (IAC)
For
Ministry of Economy, Trade and Industry
JAPAN
March 12, 2007
Table of Contents
Chapter
Page
1. Introduction
2. Program Overviews, Budget Plans
2.1. Federal Government Agencies
2.1.1. Department of Homeland Security
2.1.1.1. NBACC
2.1.2. Department of Defense
2.1.2.1. DTRA
2.1.2.2. USAMRIID
2.1.3. Department of Health and Human Services
2.1.3.1. NIAID
2.1.3.2. CDC
2.1.4. United States Department of Agriculture
2.1.4.1. APHIS
2.1.4.2. ARS
2.1.5. Food and Drug Administration
2.1.6. Department of Energy
2.1.7. National Science Foundation
2.2. New Programs & Advanced Research and Development
2.2.1. Homeland Security Advanced Research Projects Agency
2.2.2. Defense Advanced Research Projects Agency
2.2.3. National Institutes of Standards and Technologies:
Advanced Technology Program
2.3. Interagency Coordination
2.4. Cooperating with the Private Sector
1
2
4
4
5
6
7
7
9
11
13
14
15
16
17
18
19
19
19
20
22
3. Determining Priorities
3.1. Agents
3.2. Scenarios
3.3. Modeling
3.4. Monitoring
26
26
28
29
35
4. Business Development
4.1. Methods to Encourage Technology Development
4.1.1. Regional Incentives
4.2. Standards Development
4.2.1. Case Study: DoD Standards Development in Assays
4.2.2. Case Study: DHS Anthrax
4.3. Public-Private Partnerships
4.4. Trade Committees and Organizations
36
36
38
40
40
41
41
43
ii
22
24
Table of Contents
Chapter
Page
5. Procurement
5.1. Homeland Security Contracting Methods
5.2. Program Management and Oversight
5.3. History of Funding Distribution Across Federal Agencies
5.4. State Funding
48
48
49
51
53
6. Future Plans, Trends, and Homeland Security Outlook
6.1. State Involvement: Illinois – A Case Study in State Response
6.2. New Government Agencies Involved in Homeland Security:
The Pandemic and All Hazards Preparedness Act
6.3. Other Planned Activities
6.4. Emerging Areas
59
59
61
7. Conclusion
65
Appendix 1
Appendix 2
History of Federal Funding Distribution
On Biodefense
Glossary of Terms
iii
63
64
68
71
List of Figures
Figure
Page
2.1. Changes in Federal Funding for Biodefense 2001-2007
2.2. FY2007 Funding for Biodefense by Federal Agency
2.3. FY2001-FY2007 Total Funding for Biodefense by Federal Agency
3.1. Los Alamos Model: Simulated Infection Rate Per 1000 People
3.2. UASI Risk/Effectiveness Model
3.3. Score Composition in UASI Model 2007
4.1. Regional Coverage by NIH Centers of Excellence
3
3
4
30
32
34
39
A1.1. FY2001 Funding for Biodefense by Federal Agency
A1.2. FY2002 Funding for Biodefense by Federal Agency
A1.3. FY2003 Funding for Biodefense by Federal Agency
A1.4. FY2004 Funding for Biodefense by Federal Agency
A1.5. FY2005 Funding for Biodefense by Federal Agency
A1.6. FY2006 Funding for Biodefense by Federal Agency
68
68
69
69
70
70
iv
List of Tables
Table
Page
2.1. Unclassified Research Relating to Chemical-Biodefense
8
Funded by DTRA
2.2. DHHS Bioterrorism Funding
10
2.3. Areas of Major Progress by NIAID
12
2.4. Select List of Diseases Reportable to the World Organization
15
For Animal Health
2.5. Major DOE Labs Involved in Biodefense and Their Areas of Focus 18
3.1. Agents on CDC’s Threat List
27
3.2. Categories of Risk and Effectiveness Used by UASI
33
3.3. Five Largest Funding Increases as a Result of Model Implementation 33
3.4. Five Largest Funding Decreases as a Result of Model Implementation 33
3.5. CDC Disease Outbreak Data on Observed Infectious Diseases:
35
2001-2004
4.1. Three Biodefense Contracts
37
4.2. Major Non-Governmental Organizations Involved in Biodefense
43
And Biosecurity
5.1. Unobligated Funds Awarded Under the Public Health Preparedness 54
And Response for Bioterrorism Program (HHS-CDC)
5.2. States with the Highest Percentage of Unobligated Funds
55
5.3. Changes in Federal Funding for State and Local Bioterrorism
56
Preparedness FY 2005-2008
v
1.
INTRODUCTION
In “Plagues and Peoples”, William McNeil very impressively demonstrated the
astounding impact of viral diseases on human history and culture.1 This is a well known
story on the American continent, of course, given the demise of Amerindians by
unknown diseases carried over the Atlantic by the European new arrivals. The European
invaders themselves at that point still had relatively fresh memories from their own major
disruptions by widespread diseases in the Middle Ages, the better known one being the
Black Plague. Epidemics in the Far East have been quite frequent during the past several
centuries.
Take the example of influenza. Influenza viruses have been a constant threat to the health
of human (and animal) populations. Their diversity and propensity for mutation result
periodically in pandemics due to newly emerging virus strains that has the ability to
infect and be passed from individual to individual. As in the case of the hapless
Amerindians before, since humans have little immunity to the new virus, a pandemic
(worldwide epidemic) can ensue. Three human influenza pandemics have occurred in the
20th century, each infecting about one-third of the world population and terminal illness
in 0.2 percent to 2 percent of those infected. Current models of disease transmission
project that a modern pandemic could lead to the deaths of 200,000 to 2 million people in
the United States alone.2
American vulnerability to biological attack became directly apparent beginning on
October 15th, 2001, when a letter containing anthrax spores was discovered in a
Senator’s office. In the weeks following, the government mail service was shut down,
the United States Capital was closed for decontamination, and thousands of doses of
ciprofloxacin (“Cipro”) were given to mail carriers and government employees. The
attack resulted in 23 cases of anthrax infection and eleven deaths.
There is little argument that the danger of pandemics is real. While the naturally
occurring “Asian flu” has attracted a lot of attention, there is another very worrisome
aspect of this: the deliberate engineering of viruses and release into the general populace
with malicious intent. While an old technique to annihilate enemies, one is nowadays
more familiar with the Tokyo subway attacks. Only that the attack experts have in mind
is at a much, much larger scale. Countries are preparing to face either one of these two
versions of a possible pandemic.
This report concentrates on the current efforts of the United States of America.
1
2
William H. McNeill, Plagues and Peoples, 1998, New York: Anchor Books (Random House Inc.)
Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan, May 2006.
1
2. PROGRAM OVERVIEWS, BUDGET PLANS
Within the US federal government, biodefense and biosecurity is a broad issue.
Therefore, many government agencies have stakes in addressing various aspects of it,
including:

DHS: Department of Homeland Security: national strategy for domestic defense.

DOD: Department of Defense

HHS: Department of Health and Human Services
o CDC: Center for Disease Control and Prevention - monitor outbreaks and
conduct surveillance and testing on known and emerging pathogens
o NIH: National Institutes of Health - coordinates research and development
o NIAID: National Institute of Allergy and Infectious Disease
o FDA: Food and Drug Administration - ensure that food remains free of
contaminants or intentionally introduced diseases.

USDA: Department of Agriculture: protect the food supply through agricultural
biodefense research.

FDA: Food and Drug Administration

DOE: Department of Energy: DOE laboratories are used to conduct biodefense
research on behalf of DHS. Also, DOE has a role in the safety of nuclear material,
therefore they are involved in non-proliferation aspects.

NSF: National Science Foundation

EPA: Environmental Protection Agency

State: Department of State

Other agencies: Department of Commerce, U.S. Post Office, and the Veterans
Administration
There have been significant changes in both the volume and the structure of federal
funding for biodefense during the current decade. These have accompanied equally
significant changes in the organization of activities within the various agencies with the
most important one being the creation of the Department of Homeland Security.
2
Figure 2.1 shows the funding trends for biodefense in federal government.
Figure 2.1. Changes in Federal Funding for Biodefense 2001-2007 ($ m.)
The most recent breakdown by Agency is shown in Figure 2.2 below.
Figure 2.2. FY2007 Funding for Biodefense by Federal Agency ($ m.)
The average throughout the seven-year period by Agency is indicated in Figure 2.3. It
must be emphasized that a core player, The Department of Homeland Security, appears
on the scene only in 2003.
3
Figure 2.3. FY2001-FY2007 Total Funding for Biodefense by Federal Agency ($m.)
2.1. FEDERAL GOVERNMENT AGENCIES
2.1.1. Department of Homeland Security
The Department of Homeland Security (DHS) is the most recent addition to the
Executive Branch of the federal government at the Secretary level. The main role of the
Department is the prevention of any domestic security incidents and the preemption and
deterrence of terrorist activities. Importantly, the Department of Homeland Security is
responsible for ensuring that emergency situations are properly managed in the case of a
catastrophe. In addition, DHS has assumed the interdiction role previously held by the
Department of Commerce through the Customs Agency and the Coast Guard. Finally,
DHS is responsible for securing travel and transportation conduits as well as
immigration.
The DHS Office of Health Affairs (OHA) has requested 118 million dollars as part of the
President’s FY2008 budget. OHA serves as the principal advisor to the Federal
Emergency Management Agency (FEMA) and leads the Department’s biodefense
activities. Part of these activities are the National Biosurveillance Initiative and oversight
of the BioWatch program. In addition, a new Office of Animal and Agro-Defense will
develop the expertise to advise the Secretary on zoonotic and foodborne pathogens. The
Chief Medical Officer of the Department of Homeland Security operates in the Office of
Health Affairs and is responsible for coordinating the National Disaster Medical System,
DHS activities on Project BioShield, and the construction of working groups and
planning in response to the threat of pandemic influenza.
4
In addition, the President’s budget for FY2008 allocates 228.9 million dollars to DHS’
Science and Technology Directorate for chemical and biological defense. These funds
will be used to create effective measures for deterrence, detection, and mitigation.
Included in this funding profile is the transfer of an additional 84.1 million to implement
the BioWatch monitoring system in thirty cities (Box 1).
Box 1. BioWatch is an early warning system for metropolitan areas to alert the
Department of Homeland Security of the release of aerosolized pathogens. DHS
has a management and oversight role in a Memorandum of Agreement structure
that exists between DHS, the Environmental Protection Agency (EPA) and the
Centers for Disease Control (CDC). The program was first established in an 80
day period in 2003, and follow-up reviews were conducted in 2004 and 2005.
Although initial after-action reviews in 2003 indicated successful outcomes,
these later studies showed a slow deterioration in day-to-day affairs. 84 percent
of laboratories improperly transferred filters from the field to the laboratory. 74
percent of all filters were transported in improperly cleaned chain-of-custody
bags, exposing them to possible cross-contamination. Furthermore, DHS was lax
in obtaining monthly and quarterly reports from its partners in the EPA and CDC,
to whom it administers funds.
DHS management responded to a January 2007 audit by claiming that year-toyear changes in grades were not indicative of performance. In addition, within
30 days of the issuance of the report on problems with the BioWatch program,
DHS had issued corrective policy guidelines. As this program provides essential
capabilities for early detection and response to the release of a threat agent, it is
critical that problems of potential cross-contamination and improper attention to
standards are appropriately rectified.
2.1.1.1. NBACC
One critical element in the Department of Homeland Security’s attempts to provide for
biosecurity and biodefense is the National Biodefense Analysis and Countermeasures
Center (NBACC). Planning on this institution began in FY2003. The facility will be
located on the National Interagency Biodefense Campus at Fort Detrick, Maryland, and
although some scientists began research on the Fort Detrick grounds early on in 2007, the
facility will not formally open until 2008. It will share grounds with offices of the
National Institute for Allergy and Infectious Disease (NIAID), the Department of
Agriculture’s Agricultural Research Service (ARS), and the U.S. Army Medical Research
Institute of Infectious Disease (USAMRIID).
These Agencies will share overlapping missions:

NBACC: Investigate a comprehensive understanding of biological agent
characteristics
5

NIAID: Elucidate the disease process

ARS/USAMRIID): Develop products to reduce risk to human health and
agricultural productivity
NBACC’s core mission will be characterization and forensics. The Presidential Directive
“Biodefense for the 21st Century” designates the National Bioforensic Analysis Center as
the lead facility in technical forensic analysis in the aftermath of a biological attack.
Complementary to this, the Biological Threat Characterization Center will conduct
laboratory studies to improve risk analysis, identify gaps in current knowledge on
potential threat agents, and provide information to determine priorities and set standards
in the development of sensors and countermeasures.
The construction and management of NBACC was awarded to the Battelle National
Biodefense Institute (BNBI). The total contract award for facilities construction and
management was awarded in December of 2006 and consists of 250 million dollars over
five years with an option for five one-year extensions totaling another 250 million. It
should be stressed that Battelle also manages or co-manages five Department of Energy
laboratories and, thus, brings a history of expertise in chemical and biological
countermeasures development.
Although NBACC will conduct classified research, it will not be a weapons development
facility, as critics of the program alleged early on. While NBACC experts will be
encouraged to conduct “red team” exercises in order to generate possible scenarios used
by enemies of the state, these tasks will only be used to identify weaknesses and prepare
for threats. The DHS director of the NBACC program, Bernard Courtney, has stated that
counter-force research will only be done in the case of a credible bio-threat, and that
these exercises will comply with the Biological and Toxic Weapons Convention in scope
and detail.
2.1.2. Department of Defense
In 2001, the Department of Defense viewed chemical and biological defense as a problem
it was uniquely situated to handle. Congressional testimony by the Deputy Director of
Defense Research and Engineering identified modeling the dispersal of chemical and
biological weapons as a “hard” problem that would require the leveraging of a significant
amount of resources to create tractable action. The Deputy Director identified four major
areas critical to warfare: detection of biological and chemical agents, diffusion and
dispersal models for predicting hazards, improved understanding of agent toxicity, and
increased comprehension of chemical and genetic composition.
While tailored to the battleground, many of these issues have applications for the civilian
population as well. Hence, even though homeland biosecurity is the specific charge of
the Department of Homeland Security, the potential payoff of dual-use (civilian and
6
military) technologies encourages incorporation of an overview of Department of
Defense biodefense efforts into this review.
2.1.2.1. DTRA
One agency of the Department of Defense that deals with threats to biodefense and
biosecurity is the Defense Threat Reduction Agency (DTRA). DTRA was originally
created to deal, mainly, with issues of counter-proliferation following the collapse of the
Soviet Union. Much of its mission is the containment and monitoring of weapons of
mass destruction. In addition, DTRA provides counter-weapons of mass destruction
capabilities to the combatant on the tactical and operational level. DTRA models
weapons effects for weapons of mass destruction and establishes protocol in the event of
such an attack on American forces. Technologies developed by DTRA seek to safeguard
the lives of American soldiers should they be exposed to a chemical, biological, nuclear,
or radiological weapon.
While DTRA’s mission largely focuses on the development of systems that are directly
relevant to the combatant, as with other DOD programs, these technologies can be used
in the case of a weapons of mass destruction attack on civilians.
In FY 2007, DTRA’s budget contained several items dealing with chem.-bio defense
(Table 2.1).
2.1.2.2. USAMRIID
The DOD also funds biological warfare countermeasures through the U.S. Army Medical
Research Institute of Infectious Diseases (USAMRIID). Its main goal is providing
protection to combatants against biological threats. USAMRIID vaccines have also been
used in civilian emergencies, providing international allies with vaccines for outbreaks of
equine encephalitis (Venezuela, 1971), Rift Valley fever (Egypt, 1977), tularemia (Italy,
1980s), as well as diagnostic support for foreign allies during the outbreak of Severe
Acute Respiratory Syndrome (SARS). In addition, USAMRIID plays an important role
in American civilian biodefense, providing information for clinicians on medical
management in mass casualty events.
USAMRIID funds extramural research through the US Army Medical Research and
Material Command’s open competition as well as through technology transfer processes
such as cooperative research and development agreements (CRADAs). The CRADA
mechanism allows for commercial entities to be able to leverage off of military personnel
and facilities that are properly cleared for the testing of biological warfare agents. In
addition, USAMRIID patents can be licensed for commercial development.
7
Table 2.1. Unclassified Research Relating to Chemical-Biodefense Funded by DTRA
Program
Basic Research for WMD
Knowledge Gaps
FY 2007
Amount*
5,000,000
Weapons Effects
Technologies
76,462,000
Small Business Innovative
Research
2,411,000
Detection Technology
8,744,000
Counterforce
76,849,000
Description
Broad scientific and technology basic
research in critical assets for
mitigating current, emerging, and
future WMD threats. Incl. physics,
materials science, structure, biology,
chemistry, detection technology
Basic and applied research on
weapons for purposes of defeat, deny,
disrupt WMDs. Provides DOD-wide
weapons effects models including
hazardous release into atmosphere.
Includes development and validation
of chemical/biological weapon
disruptiveness models
Includes efforts on
chemical/biological agent
denial/defeat
Develop technologies to monitor,
detect, identify strategic conventional
and unconventional weapons incl.
biological/chemical sensor
technology
Includes system capability to perform
combat assessment relevant to
deployment of chemical and
biological weapons on existing
combat assessment platforms (such as
Unmanned Aerial Vehicles). Also
includes tools to enable warfighters to
engage in operations against chemical
and biological weapons facilities.
Includes tools to neutralize weapons
in real-time
8
Some patents developed by USAMRIID include3:




Ricin vaccine and methods of manufacture and use
High throughput assays for neurotoxins
A novel anthrax vaccine
Antibodies against type A botulinium neurotoxin
Under Patent License Agreements (PLA), domestic industries and small businesses pay
royalties to the institution, which passes some of the funding through to the inventor.
This encourages USAMRIID employees to make steps not only for overall mission
benefit to the agency, but for commercial benefit to themselves.
2.1.3. Department of Health and Human Services
The Department of Health and Human Services administers many of the programs related
to biosecurity. The National Institute of Allergy and Infectious Disease (NIAID) takes on
much of the responsibility for ensuring progress on basic and applied research and
development for pathogens of interest. The Centers for Disease Control (CDC) ensures
that public health officials at the state and local level are informed and prepared to
respond in the case of a biological threat incident. In addition, the CDC is the lead
agency on implementation of a surveillance system to monitor and detect biological
threat events.
The President’s budget for FY2008 recommends a 4.3 billion dollar appropriation to the
Department of Health and Human Services in order to address bioterrorism issues (Table
2.2). A portion of this will go to pandemic influenza vaccine development. Because
H5N1 influenza is an avian strain there are difficulties in producing the vaccine through
the regular methods of incubating the virus via chicken egg. As a result, HHS is pushing
development of cell-based vaccine capabilities, and in May 2006 provided an initial 1
billion dollars in funding. This initial award was made to five firms, GlaxoSmithKline
(274.5 million dollars), MedImmune (169.46 million dollars), Novartis Vaccines &
Diagnostics (220.51 million dollars), DynPort Vaccine (40.97 million dollars), and
Solvay Pharmaceuticals (298.59 million dollars).
3
USAMRIID. 2006. “Issued Patents Available for Licensing”.
https://technologytransfer.amedd.army.mil/patents.asp?SearchText=RIID&SortBy=uspto
9
Table 2.2. DHHS Bioterrorism Funding
Program/Agency
FY2008
Request
Change:
FY2007-2008
698
-125
88
137
--581
+10
---14
+90
National Institutes of Health
Biodefense Research
1,628
+18
Food and Drug
Administration
Food Defense
Vaccines/Drugs/Diagnostics
Physical Security
178
57
7
+23
+2
+.024
38
+34
13
48
+4
+33
53
+6
414
-60
---
-21
189
+135
22
9
+22
+.04
2
-.36
CDC
Upgrading State and Local
Capacity
Biosurveillance Initiative
Upgrading CDC Capacity
Anthrax Research
Strategic National Stockpile
Office of the Secretary
Revitalization of the
Commissioned Corps
Assistant Secretary for
Preparedness and Response
Operations
Preparedness and
Emergency Operations
National Disaster Medicine
System
Hospital Preparedness
Grants
Training and Curriculum
Development
Advanced Research and
Development
BioShield Management
International Early Warning
Surveillance
Media/Public Information
10
2.1.3.1. NIAID
The National Institute of Allergy and Infectious Disease controls the majority of the
research dollars allocated to the National Institutes of Health for biodefense research, and
in 2006 were responsible for 1.7 billion dollars of a 1.79 billion dollar budget. The
NIAID determines research priorities on Category A, B, and C threat agents (see Chapter
3) and oversees both intra-mural and investigator initiated research that is responsive to
their overall priorities. Priorities are determined on a pathogen by pathogen basis.
High priorities include:











High titer/concentrated Vaccinia Immune Globulin (VIG) or replacement
product based on monoclonal antibodies (Mabs)
Botulinum antitoxin including: safe and effective alternatives to toxoid
vaccine, monoclonal antibodies, and polyclonal antibodies
Development of an alternative vaccine against smallpox that could be
delivered to those at high risk of serious complications to the current
vaccinia vaccine (e.g., MVA)
Second generation anthrax vaccines (e.g., rPA)
Ebola and Marburg hemorrhagic fever vaccines
Tularemia vaccines
Plague vaccines
Rift Valley Fever vaccines
Cell culture (e.g. Vero cells) based vaccines for influenza
Antivirals for smallpox and viral hemorrhagic fevers
Arenavirus and specific viral encephalitis vaccines (e.g., Tickborne
encephalitis viruses, West Nile virus, Eastern equine encephalitis virus,
Western equine encephalitis virus)
In 2006, the NIAID completed a review of research and development addressing
Category A bioagents.4 Overall they were able to report progress in addressing the
threats posed by some of these threat pathogens, and demonstrate success in many areas
since the previous report was issued in 2003. The report highlights seven areas where
NIAID had made major progress (Table 2.3).
4
NIAID. 2006. NIAID Biodefense Research Agenda for CDC Category A Agents.
11
Table 2.3. Areas of Major Progress by NIAID
Area
Next Generation Vaccines for Anthrax and Smallpox
Multiplex Diagnostics: Rapid Detection of Emerging
Pathogens
Dengue Vaccine Development
Botulism
Decoding Anthrax
Innovative Therapeutics Against Smallpox
Fast-Acting Ebola Vaccine
Progress

Recombinant protective antigen vaccine for
anthrax tested rabbits and primates and clinical
human cohort

Post-exposure prophylaxis scenario developed
for administration of anthrax vaccine

Modified vaccinia Ankara vaccine to counter
smallpox developed, manufactured, and moved
to Phase II clinical trials

Novel smallpox vaccine developed based on
sub-units of the virus and tested in mice and
non-human primates

Animal models developed for smallpox
infection and inoculation

Methods developed capable of rapidly
screening for the presence of several pathogens

Platform capability exceeds 20 biothreat agents

Methods determined to weaken live, attenuated
virus for use in vaccine

Tetravalent dengue vaccine slated for clinical
trial in near future

Multi-monoclonal antibody approach
determined for manufacture and use in animal
models

Demonstration of previously unknown
similarities between various strains of anthrax

Strain differentiation and diagnosis
demonstrated through genomic sequencing

Two poxvirus therapeutics developed and
could potentially be used in concert with one
another

Lipid enhanced cidofivr can be orally
administered and does not accumulate in the
kidneys

ST-246 therapeutic against separate viral
target; safe preclinical toxicity profile

Vaccines offer capability to treat currently
untreatable disease

Prime-boost method successfully tested on
primates exposed to infection
Many of these activities were conducted under the auspices of Project BioShield. While
the majority of funding for Project BioShield is for procurement of vaccine stockpiles,
NIAID manages the portion of funding allocated for research and development tasks.
NIAID is able to use expedited authorities granted by the Project BioShield legislation to
fund problems which respond to urgent needs.
The 2006 annual report on Project BioShield highlights the decision to expedite research,
stating:
12
“NIAID first considered using the normal NIH review and award process;
however, because this process averages 18 months from the conception of an
initiative to award, the NIAID rejected this option. Instead, because the
Project BioShield mechanism shortens the award process timeframe to
approximately nine months, NIAID elected to utilize Project BioShield
authorities to expedite these high-priority programs.”
2.1.3.2. CDC
The Centers for Disease Control support biodefense by providing information on
incidents and outbreaks of threat pathogens of interest and coordinating public health
readiness and preparedness efforts. In addition, the CDC confirms the presence of
pathogens in a given biological sample should an outbreak occur. The CDC also
educates the public on public health awareness issues. Further, as previously discussed, it
is the CDC that takes the lead in determining the levels of threat posed by various
pathogens.
The CDC manages federal funding for state and local readiness programs through a
cooperative agreement process. Under this cooperative agreement, the CDC supports
efforts to implement the CDC Preparedness Goals and the National Preparedness Goal.
The National Preparedness Goal is a cross-agency standard framework for actors at
multiple levels of the public health system.
The CDC Preparedness Goals include:

Prevent: Increase the use of interventions known to prevent human illness
from chemical, biological, radiological agents, and naturally
occurring health threats

Detect and Report: Decrease the time necessary to classify events as
terrorist or naturally occurring; Decrease the time needed to detect
and report chemical, biological, or radiological agents in tissue,
food, or environmental samples; Improve the timelines and
accuracy of communications regarding the public’s health

Investigate: Decrease the time to identify causes, risk factors, and
appropriate interventions for those affected by threats to the
public’s health

Control: Decrease the time needed to provide countermeasures and
guidance to those affected by threats to the public’s health
13

Recover: Decrease the time needed to restore health services and
environmental safety to pre-event levels; increase the long-term
follow-up to those affected by threats to the public’s health

Improve: Decrease the time needed to implement recommendations from
after-action reports following threats to the public’s health
There is little room for discretionary funding in the cooperative agreement process. All
states will receive a minimum amount of funding of 3.91 million dollars (last available
year), and additional amounts based on proportional share of the national population.
The District of Columbia, Chicago, Los Angeles, and New York City receive an
additional 5 million dollars. However, expenditure of funds is restricted by CDC
guidance, and the CDC retains the right to terminate funding. In addition, funding
provided through the cooperative agreement process cannot be used to support research.
The CDC also funds the Early Warning Infectious Disease Surveillance (EWIDS)
program through the cooperative agreement program (Box 2).
Box 2. EWIDS is an initiative that attempts to improve epidemiological
capabilities for cross-border states in order to prevent the incursion of foreignborne or emerging pathogens. States along the U.S.-Mexico border have begun
to implement an additional system that will allow coordination between public
health data collection agencies in the United States and those in Mexico. Award
size is determined by the number of border crossings.
In addition, the CDC maintains information for interested parties on various
characteristics of biological threat agents. Through the Clinician Outreach and
Communication Activity (COCA) and the Clinician Registry for Terrorism and
Emergency Response Updates and Training Opportunities, the CDC attempts to ensure a
baseline level of awareness for interested medical practitioners.
Finally, the CDC conducts verification tests on biological samples for state and local
public health officials. By publishing guidelines and providing a final verification
measure on the severity of a potential threat, the CDC can act as a single standard for the
presence or absence of a threat agent.
2.1.4. United States Department of Agriculture
The Department of Agriculture plays several roles in ensuring biodefense and
biosecurity. The USDA is responsible for monitoring the spread and outbreak of
zoonotic diseases, several of which can pose severe threats to biosecurity (avian
influenza, bovine spongiform encephalopathy). Further, the USDA ensures the safety of
agricultural products for consumption and attempts to place safeguards to prevent
tampering at the pre-market stages.
14
Roles are divided into several sub-services. The Animal and Plant Health Inspection
Service (APHIS) is responsible for monitoring animal and plant populations. The
Agricultural Research Service (ARS) leads the development of technical solutions and
research programs targeted at major areas of concern.
2.1.4.1. APHIS
The data collected by the Animal and Plant Health Inspection Service on animal-animal
transmissions of a virus assists the Centers for Disease Control in their ability to track
and react to the spread of disease. It was in this capacity that APHIS played a part in
observing the outbreak of the West Nile encephalitis, a mosquito-borne disease that is
fatal in humans, from 1999 to 2001, with their data on horse populations informing
researchers into areas of likely outbreak. As this disease was novel in the United States,
APHIS played a critical role in informing epidemiological modelers, who then were able
to better educate the public as well as contain the disease by introducing measures to
limit mosquito populations.
APHIS also has a role in interdiction. On average, 38,000 animals enter the United States
per day. These animals may be carrying one of 150 zoonotic diseases foreign to
populations in the United States, some of which have potential for serious disruption if
introduced into existing flocks. The World Organization for Animal Health (OIE), an
international animal health monitoring organization, maintains a list of reportable
diseases for its members. A number of the diseases of concern to the OIE also appear on
the CDC list of biological threat agents.
Table 2.4. Select List of Diseases Reportable to the World Organization for Animal
Health
Disease
Anthrax
Tularemia
Brucellosis
Glanders
Q Fever
Viral encephalitis
Nipah virus
Animal
Multiple Species
Multiple Species
Multiple Species
Equine
Multiple Species
Multiple Species
Swine
CDC Classification
A
A
B
B
B
B
C
Bioterrorism in animal and plant populations may not be conducted solely for the
purposes of damages to human populations. Plant or animal pathogens may be
introduced into populations in order to cause economic disruption. The structure
(concentration) of modern agro-business in the United States enables such outbreaks to
be potentially devastating.
15
While the United States has a diverse agricultural production base, often production of a
given crop is geographically homogenous. Over 90 percent of all grape production is
located in California. Around 75 percent of citrus is produced in Florida. By introducing
a plant-specific agent into these concentrated agricultural zones, a group could feasibly
eliminate the ability to produce a certain crop. Naturally occurring wheat seed blights in
the 1990s caused nearly $3 billion in damages and led to agricultural sanctions against
the United States from 50 nations. A directed attack could lead to magnitudes greater
damage.
In animal populations the modern farm is especially vulnerable. Poultry farms can
contain hundreds of thousands of birds, all of whom may need to be culled if exposed to
pathogen. Feedlots for cattle can hold up to 300,000 head. Introduction of zoonotic
diseases into such facilities could cause global fluctuations in the price of beef.
Clearly, monitoring and surveilling animal populations for the introduction of foreign
disease or intentional infection becomes a priority in an environment where biological
terrorism and bio-security are major concerns.
2.1.4.2. ARS
The Agricultural Research Service enhances the abilities of APHIS to monitor animal
populations by continuing to research and refine new methods and models for disease
detection. While they traditionally focus on therapeutics development, vaccines, and
diagnostics for naturally occurring outbreaks, biodefense has moved up on their priority
list in recent years. Under National Program 103 (NP 103) the ARS has structured a plan
for future engagement in animal health research.
In the area of biodefense, foreign animal diseases were identified as the lead concern by
the beef and poultry industry at a 2005 stakeholder meeting conducted by the USDA.
The leading strategy of control, disease eradication by elimination of the animal, would
both lead to immediate economic losses and potential future repercussions in the form of
closure of foreign and domestic markets. This was deemed as unacceptable by the
stakeholders, who also found current methods to monitor and prevent disease
transmission as inadequate. In addition, the potential damage caused by an emergent
disease was also seen as a high risk. The ARS determined the following outputs would
be necessary goals for future research and program management:






Better anticipation of introduction of foreign animal diseases
Researcher advisory roles in the regulatory process
Increased capability to produce effective control and elimination products
Real-time detection of agents across differing types of farms
Searchable genomic and proteomic databases for major known foreign
animal disease agents
Discovery of effective biotherapeutics and candidate vaccines that would
allow differentiation of infected and vaccinated animals
16






Predictors of emerging livestock diseases
Identification of pathogens associated with emerging disease
Methods to detect and characterize the etiology of new disease
Development of predictors of outbreak
Establishment of early warning systems
Tools and expertise to implement countermeasures to disease outbreaks
By monitoring the outbreak and spread of disease and interdicting potentially devastating
foreign animal diseases, the USDA attempts to ensure biosecurity in the production
capability of the food supply. Through working together with stakeholders on identifying
areas of major concern to producers, the USDA attempts to guide research funding to
enable the greatest impact. In doing so, the USDA bolsters economic security against
potential threat and strengthens the safety and well-being of the American population
from food-borne and zoonotic pathogens.
2.1.5. Food and Drug Administration
The Food and Drug Administration (FDA) is responsible for ensuring the safety of the
food supply as well as for regulatory oversight of biotherapeutics and vaccines.
Therefore, the FDA plays a number of roles in biodefense by both ensuring that food
supplies are not tampered with through the introduction of a pathogen and by ensuring
that necessary countermeasures to a potential biological attack are available.
In its role in ensuring the safety of biological products, the FDA requires commercial
products to undergo lengthy and rigorous clinical trials to demonstrate safety and efficacy
for their intended use. In the case of agents that have applications in countering potential
bioterrorist agents, the FDA has considered using expedited review processes to ensure
adequate stockpiles are available to the public. The difficulty in properly testing such
agents is compounded by the difficulty in conducting validation studies, as human studies
are not typically feasible, and it is not clear how useful animal data is without clear
human correlates. The FDA operates under the recognition that something is better than
nothing, and that the American public expects some type of response to be available.
The FDA has an office of Counter-Terrorism Policy and Planning that works in
partnership with the Departments of Health and Human Services (incl. NIH and CDC),
Defense, and Homeland Security to identify gap areas where there is a critical need for
countermeasures. Some leading areas of concern are in the development of vaccines for
anthrax and smallpox, Botulinum anti-toxin, and vaccinia and anthrax immune globulins.
In addition, the FDA attempts to ensure the development of assays capable of resolving
and validating the efficacy of these agents. Commercial sector entities are encouraged to
contact the FDA early and often to ensure that their product receives proper treatment,
and more attention is spent on agents that are responsive to the higher priority concerns.
This process was used in 2005, when the FDA expedited the review of two products
which lessened the impact of complications caused by smallpox vaccines.
17
2.1.6. Department of Energy
Historically, one of the charges of the Department of Energy has been Nuclear Security,
with a number of programs in this policy area administered by the National Nuclear
Security Administration (NNSA). Over time, the reach of the NNSA grew to incorporate
countermeasures against other weapons of mass destruction. In 1997, the Defense
Against Weapons of Mass Destruction Act authorized the creation of the Chemical and
Biological National Security Program under the auspices of the NNSA’s Office of Nonproliferation Research and Engineering. This program operates between researchers at
various Department of Energy laboratories with a focus on countering domestic threats
against civilians.
The DOE laboratories are Federally Funded Research and Development Centers
(FFRDCs), each laboratory is managed either by a university or by an industrial firm.
FFRDCs are not subject to the same labor regulations that apply to the rest of the civil
service. This flexibility allows an FFRDC to more directly focus on sets of core
competencies, and various FFRDCs have become known for their areas of specialization.
Table 2.5. Major DOE Labs Involved in Biodefense and Their Areas of Focus
Laboratory
Idaho National Laboratory
Managed By
Bechtel BWXT Idaho, LLC
Sandia National
Laboratories
Lockheed Martin Corp.
Argonne National
Laboratory
Lawrence Livermore
National Laboratory
Los Alamos National
Laboratory
University of Chicago
Oak Ridge National
Laboratory
Pacific Northwest National
Laboratory
UT-Battelle, LLC
University of California
University of California
Battelle Memorial Institute
18
Focus
Biological threat detection,
agricultural threat agent
countermeasures
Biological countermeasures,
sensors, decontamination,
modeling and simulation,
non-proliferation
Molecular and cell biology
for therapeutics
Pathogen detection and
identification, bio-forensics
Modeling and simulation,
vaccine development,
pathogen detection and
analysis, bio-forensics
Biological sensors, chem.bio countermeasures,
Biological sensors, systems
biology modeling, early
warning systems for
pathogen detection
2.1.7. National Science Foundation
The National Science Foundation also has an interest in homeland security and
biodefense. Specifically, the NSF attempts to leverage against its access to core
communities in information technology and computing sciences in order to bolster robust
responses to biodefense. In 2002, the NSF expressed an interest in a National Biodefense
Information Service.
Early detection in the case of a biodefense attack is dependent on correct identification.
In 2002, the system architecture was such that relevant data was not captured by the
system. In order to identify an attack, clinicians would have to observe relevant
symptoms in their local practices and identify these symptoms as anomalous. Then, these
clinicians would contact local public health agencies, who would filter data upwards to
state agencies, and finally to the CDC. Identification in an early stage would require
patients presenting to clinicians at early time points following an attack, and many
potential agents could be transmissible prior to the appearance of symptoms. A large
portion of the data relevant to a biological attack would simply fall through the cracks of
the system
Given these limitations, the NSF proposed an alternative system with many more points
of data capture. The “National Biodefense Information System” would track data such as
absenteeism from work, pharmacy purchases, laboratory and clinical information, calls to
emergency services, and potential other relevant pieces of information. This system
would serve as a constant anomaly detector. Such a detector would require high
specificity and sensitivity to maintain accuracy while preventing false alarm.
2.2. NEW PROGRAMS & ADVANCED RESEARCH AND DEVELOPMENT
New agencies and new programs in biodefence and homeland security are the subject of
Sections 6.2-6.4 in this document. We refer the reader to those Sections.
The remainder of this Section is devoted to advanced research and development.
2.2.1. Homeland Security Advanced Research Projects Agency
The Homeland Security Advanced Research Projects Agency (HSARPA) was formed as
part of the Department of Homeland Security’s research and development portfolio.
HSARPA was modeled after the Defense Advanced Projects Agency (DARPA).
However, while DARPA is charged exclusively with producing and sponsoring cuttingedge research, HSARPA includes acquisition of near-market products essential to
Homeland Security in its portfolio.
19
HSARPA has used the Broad Agency Announcement (BAA) system for most of its work
in chemical and biological defense solicitations. Published solicitations have, for
example, included the following subjects:

Detection Systems for Biological and Chemical Countermeasures
(HSARPA RA-01): Develop, field-test, and transition next-generation
biological and chemical detectors for counter-WMD

Bioinformatics and Assays Development Program (HSARPA BAA04-03):
Extend existing detection and forensics assays; develop next-generation
assays and tools for assay development

Instantaneous Bio-Aerosol Detector Systems (HSARPA BAA04-18):
Develop, test, transition next-generation rapid bio-aerosol sensors for use
in “Detect-to-Protect” architectures

Food Biological Agent Detection Sensor (HSARPA BAA05-06): Highconfidence microbial detection systems capable of rapid throughput and
implementation at food manufacturing facilities

Low-Cost Bio-Aerosol Detector Systems (HSARPA BAA05-08):
Specifically aimed at enhancing Detect-to-Protect architecture by
implementation of < $1000 sensors
RA-01 serves as the backbone for the BioWatch system, developing the sensors integral
to the “Detect-to-Protect” architecture. As this program began in 2003 and the first
sensors were implemented later in the same year, BioWatch clearly has a very aggressive
research and development pathway. The majority of other efforts by HSARPA are also
in the field of sensor and detection technologies.
HSARPA also coordinates with the Technical Support Working Group (TSWG) on a
variety of projects. The Technical Support Working Group is a counter-terrorism
working group that assists the federal agencies in coordinating interagency efforts.
TSWG has coordinated with HSARPA and DHS on implementing, developing, and
testing some of the sensors and methods resulting from HSARPA’s biodefense programs.
2.2.2. Defense Advanced Research Projects Agency
Founded in 1958 in response to the Soviet launch of Sputnik, the Defense Advanced
Research Projects Agency (DARPA) has been tasked with ensuring that America avoids
strategic surprise on the battlefield and that the technological capabilities of the fighting
force are unparalleled. Through sponsored research, DARPA has made notable
achievements that have seen use in both the civilian and military sectors including the
development of the Global Positioning System, the Unmanned Aerial Vehicle, the Titan
20
missile, stealth technology, titanium steel, and, most famously, the Internet. DARPA
programs challenge existing paradigms and attempt to push the boundaries of innovation.
Organizationally, DARPA is split up into six program offices, each with a distinct
portfolio. The Defense Sciences Office (DSO) establishes and manages programs in the
realm of biodefense and biosecurity as part of its Biological Sciences mission. Currently,
the agency has an interest in the following areas:

Accelerated Manufacture of Pharmaceuticals (AMP) – Provide essential
therapeutics on demand in response to a pathogen outbreak

Intestinal Fortitude – Utilizing beneficial bacteria in the intestinal tract to
prevent the acquisition of enteric disease from foodborne pathogens

Rapid Vaccine Assessment (RVA) – Assess the viability of vaccines at
early stages of development through the use of simulated environments

Self Decontaminating Surfaces - Create biocidal coatings that are selfcleaning and renewable based on their surface morphology
In addition, the DSO is investigating areas such as pre-symptomatic disease detection and
rapid vaccine production.
These programs are all funded through the Broad Agency Announcement (BAA) process
and have specific milestones and metrics provided in the solicitations. Performers can
also apply to the open BAA which highlights areas of general interest to the office.
Proposals funded under the open BAA generally must provide fundamental shifts in
understanding of their respective topic; the office rarely considers technology or research
that would provide an incremental advance, or technology that is near-market in terms of
viability. Such tasks are outside of what DSO sees as its essential mission profile, that of
being the office in the agency that explores the far side of scientific investigation.
Other program offices in DARPA that deal with biodefense do so inside their specific
mission profile. The Strategic Technology Office, charged with innovation in generating
technologies that have theatre-wide impact, sponsors the Threat Agent Cloud Tactical
Intercept and Countermeasure (TACTIC) program, which seeks to notify commanders in
the field of a chemical or biological warfare agent attack and provide capability to
neutralize the attack. Additionally, DARPA uses DOD’s Small Business Innovation
Research program (SBIR) and the Small Business Technology Transfer program (STTR)
to make further awards in biodefense and biosecurity.
Many DARPA programs have eventual dual-use applications in the civilian sector, and
technology developed by DARPA for the military can be applied by other agencies for
homeland defense. While methods for countering pathogens are designed to ensure the
viability of our fighting force, these technologies could be put to clear use in maintaining
strategic stockpiles of counter-agent.
21
2.2.3. National Institutes of Standards and Technology: Advanced Technology
Program
The National Institute of Standards and Technology (NIST) is also interested in the hightechnology research and development. Through their Advanced Technology Program
(ATP), NIST engages in cost-sharing agreements on programs that are high-risk and
high-reward that have potential payoffs for the overall public good. During 2001-2004,
NIST had expended 164 million dollars on biotechnology applications.
ATP programs are generally concerned with two major areas, scientific and technological
merit and potential for broad-based economic benefits. Each area is equally weighted in
the decision process and consists of three major criteria. Scientific and technological
merit is judged on the basis of technical innovation, technical risk with evidence of
scientific feasibility, and technical plan. Potential for broad-based economic benefits is
measured by national economic benefits, need for ATP funding, and how difficult the
pathway is to realizing those economic benefits.
Each proposal goes through four gates:

Gate 1: Detailed information addressing scientific and technical merit
selection criteria and preliminary information address the potential
for broad-based economic benefit

Gate 2: Detailed information addressing the potential for broad-based
economic benefit and submission of a budget narrative

Gate 3: Oral review and submission of additional information per request
of ATP

Gate 4: Final selection
ATP does not fund basic research or very applied research such as Phase II through Phase
IV clinical trials. While funding is available for general biotechnology research, there are
no programs specifically related to biodefense or biosecurity. However, this does not
prevent ATP from funding efforts in that program area, should the proposer meet the
various other criteria generated by ATP.
2.3. INTERAGENCY COORDINATION
A good deal of interagency coordination is conducted at the strategic planning level by
the office of the President.
One example of this approach to coordinated response can be seen in the National
Strategy for Pandemic Influenza. The National Strategy for Pandemic Influenza
22
document outlines specific metrics and milestones for each of the federal agencies
involved with coordinating and mobilizing a response to pandemic flu. The
Implementation Plan for the National Strategy was first published in May of 2006, and
requires follow-up every six months. Many of the efforts covered under the National
Strategy for Pandemic Influenza also build biosecurity and biodefense infrastructure in
the case of an outbreak of a man-made agent.
Six months later (December 2006) progress was observed on numerous inter-agency
milestones, including:

Travel notifications on avian and pandemic influenza outbreaks
coordinated by the Department of State and the Department of Health and
Human Services

Transportation and border-related pandemic planning was conducted
through the Departments of Transportation, Homeland Security, Health
and Human Services, and Agriculture through a review of grants and
federal funding programs

Workforce educational materials for airline crews and passengers as well
as Travel Industry employees were generated by the Departments of
Labor, Transportation, Health and Human Services, and Homeland
Security

Screening of cargo and travelers from affected was improved through
coordination between the Department of Homeland Security, the
Department of Health and Human Services, the Department of State, and
the Treasury

The Department of Homeland Security, the Department of Health and
Human Services, the Department of Justice, the Department of
Transportation, and the Department of Defense fulfilled 70 percent of all
submitted training requests for incident response to pandemic influenza
In addition, a working group on bioterrorism has been mandated by Sec. 108 of P.L. 107188, the Public Health Security and Bioterrorism Preparedness and Response Act of
2002. This working group consists of the DHHS and DOD Secretaries, as well as other
agency leaders. Interagency guidance is provided by the Homeland Security Council.
Furthermore, Memorandums of Agreement such as the one covering BioWatch are also
used to implement policy in areas of overlap between agencies. However, evidence from
the BioWatch program shows that such programs are often difficult to properly
implement. Although the Department of Homeland Security was in control of the
funding for the Environmental Protection Agency and the Department of Health and
Human Services on that program, they were unable to properly ensure that those agencies
carried out their tasks in the appropriate fashion.
23
Distinct from the operational level of strategic planning is the level of coordination on
mandate tasks at the operational level. For example, while the Department of Homeland
Security is directed to take the lead in the Medical Countermeasure Development, they
are expected to take advantage of overlap with other departments and agencies that have
similar goals. Frequently, these opportunities arise not from formal direction on the part
of management in the federal agencies, but from discussion between program managers
at government agencies assigned with responsibility in a specific program area.
2.4. COOPERATING WITH THE PRIVATE SECTOR
Coordination for research and development in the public interest is done in a variety of
ways. Apart from direct dialogue between funding agencies and potential performers,
some organizations have been established in order to better facilitate cooperation.
Entities like research parks receive subsidies in order to provide low- or no-cost facilities
to entrepreneurial researchers, often from local universities. Scientific incubators provide
a clearinghouse for research and development firms with common interests and goals,
offering contacts with venture capitalists or well-developed contacts with federal funding
agencies.
One of the most interesting examples of business incubators with an edge on national
security (including biodefense) is the Chesapeake Innovation Center (CIC), located in
Maryland’s Anne Arundel County.5 Characterized as a “business accelerator”, the CIC
was established by the Economic Development Corporation of the County to focus
entrepreneurial talent on security-related opportunities. The CIC maintains partnerships
with both public and private sector entities. It sources and screens early stage technology
companies and connects them to networks of large industrial companies. In addition to
playing the role of active network gateway, the CIC operates incubation facilities where
selected early stage technology companies are mentored and provided with a menu of
services typical to incubators of small high-tech companies including customer contracts,
funding, staffing, subject matter experts, clearances, government contracting issues, and
office facilities.
In 2005 the CIC joined forces with six other partners, each from a different state, to form
the Technology Acceleration for National Security (TANS) network of high-tech
business incubators (Box 3).
5
See http://www.cic-tech.org/index.html.
24
Box 3. The Technology Acceleration for National Security (TANS) is an
example of a technology business incubator focusing on security issues,
including biodefense. Launched in 2005, TANS is headed up by the Chesapeake
Innovation Center (CIC) and incorporates partner business incubators from
Alabama, Colorado, Georgia, Maryland, New York, and Texas. At the time of
launch, the network encompassed over 100 small businesses and planned to grow
into several more states.
One of the partners is the Georgia component of TANS is the Advanced
Technology Development Center (ATDC). ATDC is affiliated with the Georgia
Institute of Technology and is located proximal to Atlanta, Georgia. Its
membership includes firms with expertise in wound healing, pharmaceutical
quality control, and treatment of central nervous system diseases and disorders.
ATDC also maintains close relationships with Georgia Tech Entrepreneur
Services, a company affiliated with the State of Georgia in creating partnerships
for technology development that assists small companies through the SBIR
process.
Another partner is the Texas Research & Technology Foundation (TRTF), itself a
partnership of organizations whose work involves various stages of complex drug
development process. Yet a third partner is the Watervliet Innovation Center
(WIC), a modern business incubation program focused on accelerating the
growth of emerging homeland defense and security technology
companies.
The interesting aspect of TRANS is the envisioned large network of hightech business incubation facilities and programs, some of them more
explicitly focused on security issues than others, which may create the
critical mass to harness entrepreneurial ingenuity to resolve some of the
pressing problems in homeland security.
25
3. DETERMINING PRIORITIES
3.1. AGENTS
One common standard for the classification of biological warfare threats comes from the
Centers for Disease Control. The CDC maintains a list of potential threat agents based on
several criteria, including:
• ease of dissemination
• mortality rates
• potential for social disruption
• capability for public health actors to readily respond
The CDC standards are used throughout the government as a common point of reference.
For instance, the National Institute for Allergy and Infectious Diseases uses it to allocate
funding for pathogen research and countermeasures by severity of threat agent, with
proposals dealing with Category A agents receiving priority for funding. The list is
maintained by the CDC’s Preparedness and Response Office.
The origins of CDC’s list of potential threat agents can be traced back to a meeting in
June of 1999 which established basic criteria for inclusion and categorization. The panel
was composed of cross-section of civilian, military, and intelligence experts. The threat
agents considered for assessment were drawn from a variety of unclassified sources,
including the Select Agent Rule list, the Australian Group List for Biological Agents for
Export Control, the unclassified military list of biological warfare agents, the Biological
Weapons Convention List, and the World Health Organization Biological Weapons List.
Those individuals with security clearances reviewed classified intelligence information
relevant to the threat agents of interest. However, no information was provided on the
likelihood of use of one agent over another. The Inclusion criteria included:

Public health impact based on illness and death

Potential delivery methods based on agent stability, ability to mass
produce, and potential person-to-person transmission

Public perception related to fear and potential disruption

Special preparedness requirements based on diagnostic needs, stockpile
requirements, or enhanced surveillance
26
The list contains three categories of diseases/threat agents: category A, category B and
category C.
Category A Diseases/Agents:

Transmission: Can be easily transmitted from person to person

Mortality: Have a high mortality rate potential for “major” public impact

Social effects: May cause public panic/social disruption

Infrastructure: Require special attention to public health preparedness
Category B Diseases/Agents:

Transmission: Are moderately easy to disseminate

Mortality: Result in low mortality but high morbidity

Infrastructure: Require CDC’s diagnostic capability and disease
surveillance
Category C Diseases/Agents

Emerging threats and pathogens that may be easy to disseminate, readily
available, and have the potential for high mortality/morbidity
Table 3.1. Agents on CDC’s Threat List
Category
Category A
Category B
Category C: Emerging Infectious Diseases
Disease
Anthrax
Botulism
Plague
Smallpox
Tularemia
Viral hemorrhagic fevers (incl. filoviruses
such as Ebola, Marburg and arenaviruses
such as Lassa and Machupol)
Brucellosis
Epsilon toxin of Clostridium perfringens
Food safety threats (Salmonella, E. Coli)
Glanders
Meliodosis
Psittacosis
Q Fever
Ricin toxin from Ricinus communis (castor
beans)
Typhus fever
Viral encephalitis
Water safety threats (Vibro cholorae,
Cryptosporidium parvum)
Nipah Virus
Hantavirus
27
3.2. SCENARIOS
One type of analysis utilized by policy makers interested in bio-defense is scenario based
forecasting. In these exercises, actors from a variety of relevant backgrounds in public
sector management, health care, and clinical and scientific expertise gather and discuss
potential outcomes from given events. Through role-playing, these groups are able to
determine gaps in capability that they may have otherwise overlooked.
In 1999, the CDC, along with Johns Hopkins University, examined two possible
scenarios of a Category A agent attack on a fictional United States city. The two
scenarios, using anthrax and smallpox, highlighted shortcomings in disaster preparedness
pre-September 11th. Both scenarios demonstrated potential catastrophe (Box 4).
Box 4. The anthrax scenario investigated the acute and chronic response to
deployment via aerosol spray onto a major sports stadium during a game,
targeted from a nearby highway. Symptoms would begin to emerge two days
later, appearing as flu-like symptoms. At the point at which the appropriate
cause, anthrax, would be diagnosed, hospitals across the city would be beyond
capacity. Treatment for anthrax must be administered pre-symptomatically in the
event that care is unavailable in the early stages of the disease, and without the
ability to trace the attack back to a common event, the football game, there would
almost certainly be improper distribution of an already limited supply of
countermeasure. By the seventh day following attack, 2,400 onlookers, of
16,000 exposed in the initial attack, will have died, city morgues will have filled
up far beyond capacity, and most city employees responsible for maintaining
infrastructure and civic order will not be attending work. 1,600 more will die in
the chronic phase of illness, and 250,000 will receive antibiotics. The area
around the stadium will have to be decontaminated at the cost of millions to the
city, and property values will plummet. Economic damages will range in the
billions, both from treatment cost and lost man hours6.
Since the 1999 exercise, additional information can be gathered from the anthrax attack
that did occur. In October 2001 a still unidentified individual mailed anthrax specimens
to the U.S. House of Representatives and U.S. Senate. In the months that followed the
Illinois Department of Public Health received 1,500 samples for testing, at a location
remote from the initial attacks. Potential overflow of the alertness system with false
alarms such as these could present a complication in the case of an actual attack7.
6
. Inglesby, T. V. July 1999. “Anthrax: A Possible Case-History”, Emerging Infectious Diseases, 5(4): 556560.
7
. Dworkin, M., Ma X., and R. G. Golash. April 2003. “Fear of Bioterrorism and Implications for Public
Health Preparedness,” ”, Emerging Infectious Diseases, 9(4): 503-505.
28
The economic damage and loss of life posed by an anthrax attack are limited in
comparison with the potential damage of smallpox (box 5). Unlike anthrax, which
requires inhalation of the spores, smallpox transmits from individual to individual as an
aerosol.
Box 5. The 1999 smallpox scenario explored the chain of events following
initial exposure on a crowd of people gathered to support a political candidate,
the vice president, on a campaign stop. One thousand people are gathered to
watch the vice president speak.
Eleven days after initial exposure, patient zero, a 20 year old male, presents to
the emergency room with fever, paleness, and a rash. An initial diagnosis of
Dengue is made. The appropriate diagnosis is made fourteen days after initial
exposure, and the hospital where the first appropriate diagnosis is made is
quarantined. Over the following two days thirty-five more individuals test
positive for smallpox at eight emergency rooms in the area, and ten more
individuals test positive in an adjoining state. One week later, the disease has
spread to another major urban center one week over. Three days following that,
over 700 cases have been reported worldwide. All patients have been
quarantined as soon as the virus has been identified. Two months after initial
exposure the virus has spread out across the country. Smallpox, a disease once
thought eradicated, has returned. Civic life has ground to a halt in many parts of
the country, and foreign travel is limited. By the end of the year, endemic
smallpox is present in fourteen countries8.
Exercises such as this allow policy makers to highlight weak points in preparedness for
biological attack using discrete and relevant outcomes in constrained systems. While
they are imperfect, in that conclusions are generated based on suppositions and estimates,
they still provide a feasible range of events. Measurable terms such as virulence, length
of incubation, and initial number of individual exposed provide a statistical backbone.
3.3. MODELING
In addition to determining the level of threat through scenario type exercises, some
agencies will attempt to create discrete models of potential damage caused by a
biological agent. Los Alamos National Labs created one such model in an attempt to
measure the potential damage caused by pandemic influenza (H5N1). In their model they
assumed that a small group of individuals would arrive in the Los Angeles Airport
carrying the virus. Following initial exposure, individuals would follow travel advisories
and limit long-range travel. By mathematically representing such factors as rate of travel,
incubation time, and viral spread, the researchers were able to model how a biological
agent could be transmitted if prophylaxis and vaccine measures were not readily taken9.
8
O’Toole, T. July 1999. “Smallpox: An Attack Scenario,” Emerging Infectious Diseases, 5(4): 540-546.
Germann, T, Kadau, K, Macken, C, and I Longini Jr. 2005. Pandemic Flu.
http://www.lanl.gov/news/images/avianflu.shtml
9
29
Figure 3.1. Los Alamos Model: Simulated Infection Rate per 1000 People.
30
Blue: < 1 person infected per 1,000 people
Green: 50-100 infections per 1,000 people
Red: > 100 infections per 1,000 people
Rates of infection peak at the 90 day mark
Models such as this can be created for a variety of other biological agents, and provide
clear demonstration of risks involved to populations. Census and labor statistics are
used, in this example, in order to determine population flows. The introduction of other
variables such as quarantine measures, school closures, or outright travel bans can be
measured vis a vis successful containment.
While epidemiological models of potential virulence, such as that composed by Los
Alamos, serve as indicators of severity of illness, policy makers also use risk analysis in
order to determine where best to allocate resources. The Urban Areas Security Initiative
(UASI) is a Department of Homeland Security program that allocates funding to states
and municipalities based through the Homeland Security Grant Program. After early
criticism that some of its funding was allocated along political lines rather than need, the
DHS implemented risk analysis models in order to determine where funding was most
appropriately directed.
In Fiscal Year 2006 this model was constructed in a three part process. Initially, risk
analysis models were used to compute an overall risk score. Following this, peer review
determined the relative effectiveness of proposed solutions. A combination of the risk
and effectiveness scores was used to create a risk/effectiveness matrix.
31
Figure 3.2. UASI Risk/Effectiveness Model
The risk model was constructed by measures of threat, vulnerability, and consequence.
In addition, geographic and asset-based risk scores for a given urban area were calculated
independently. Geographic risk was computed based on counts of suspicious incidents,
numbers of visitors from countries of interest, and overall population. Asset-based risk
was generated using a variety of “attack scenarios” on targets of value such as chemical
plants, dams, or commercial airports. In computing the final score, geographic risk was
weighted twice as heavily as asset-based risk. This score determined the minimum risk
that an urban area required before it could apply for funding.
The effectiveness analysis was a new requirement for the FY 2006 funding period.
Proposers were required to identify sets of solutions to homeland security needs that were
defined during the strategic planning process. The Department of Homeland Security
then assembled seventeen panels composed of cross-sections of stakeholders that
attempted to be representative of required expertise as well as levels of government.
Proposals were scored based on relevance to National Preparedness Goals, potential
impact, state, local and regional needs, implementation of investment, and sustainability
of proposed investment.
These scores then were used to prioritize funding amounts by separating proposals into
four categories, with all forty-six urban areas deemed relevant by the initial risk analysis
receiving some amount of funding (Table 3.2).
32
Table 3.2. Categories of Risk and Effectiveness Used by UASI
Category
Category I
Category II
Category III
Category IV
Description
High risk, high effectiveness
High risk, low effectiveness
Low risk, high effectiveness
Low risk, low effectiveness
Approximately seventy percent of all funding was granted to Category I and II Urban
areas. Risk was preferable to effectiveness, as the risk score comprised two-thirds of the
determinant for funding. Use of this process resulted in, in several cases, drastic changes
to funding profiles for some metropolitan areas (Tables 3.3, 3.4).
Table 3.3. Five Largest Funding Increases as a Result of Model Implementation
Metropolitan area
NJ – Jersey
City/Newark
NC – Charlotte
GA – Atlanta
WI – Milwaukee
FL – Jacksonville
Fiscal Year 2005
Allocation
19,172,120
Fiscal Year 2006
Allocation
34,330,000
Percentage change
5,479,243
13,117,499
6,325,872
6,882,493
8,970,000
18,660,000
8,570,000
9,270,000
+64%
+42%
+35%
+35%
+79%
Table 3.4. Five Largest Funding Decreases as a Result of Model Implementation
Metropolitan area
CO – Denver
LA – New Orleans
PA – Pittsburgh
TX – Dallas/Fort
Worth
OH – Columbus
Fiscal Year 2005
Allocation
8,718,395
9,305,180
9,635,991
24,335,870
Fiscal Year 2006
Allocation
4,380,000
4,690,000
4,870,000
13,830,000
Percentage change
7,573,005
4,320,000
-43%
-50%
-50%
-49%
-43%
For the UASI process in Fiscal Year 2007, the Department of Homeland Security
proposed further changes in the model. In order to make the process more easily
understood to stakeholders, DHS simplified the risk model into a single hundred point
score mechanism. Additionally, the model focused on consequences of a serious attack
33
and eliminated differential vulnerability assessments, choosing to view all areas as
equally vulnerable. Further, decision-makers at DHS were able to draw from historical
threat information compiled by the intelligence services. For purposes of the 2007
model, threat was assigned a 20 point value, and consequences of an attack were assigned
80 points. A breakdown of the composition of the score is shown in Figure 3.3 below.
Figure 3.3. Score Composition in UASI Model 2007
(DIB: Defense Industrial Base)
Infrastructure assets were grouped into two tiers. Tier I infrastructure assets were those
which, if attacked, would result in losses similar to scale as those generated by the attacks
of September 11th and the natural devastation of Hurricane Katrina. Tier II assets were
defined as assets which, if attacked, would have national and regional impact. In the
analysis, Tier I assets were scored with three times the weight of Tier II assets.
In the 2007 process, the effectiveness analysis remained the same. However, an addition
was added for computation of final score. A five to eight percent multiplier was granted
to those plans that included investments that would assist more than one region. The
2007 process also implemented a mid-year review which would allow interested areas to
submit proposals for review and comment before submission of a final proposal.
A GAO audit of this process completed in February of 2007 provided several areas which
DHS can continue to improve:
34
•
The risk modeling that DHS currently uses in the process could be bolstered by
the inclusion of standards on uncertainty modeling developed by the Office of
Management and Budget. OMB guidelines, specifically, attempt to capture
outcome sensitivity to various sources of uncertainty.
•
DHS does not seem to fully understand the effect of modifications to its modeling
processes on policy outcomes. While changes in funding levels have resulted
from changes to modeling, it is unclear as to which factors, specifically, resulted
in these outcomes.
•
The modeling process relies on expert judgment for computing several factors,
which, while preferred to an uninformed model, is still somewhat arbitrary.
3.4. MONITORING
Another tool used by policy-makers to determine priorities when dealing with potential
biological threat agents is monitoring existing information on disease outbreak. The
CDC, through the National Notifiable Diseases Surveillance System conducts weekly
updates on identified cases of some threat agents of interest. This information is
voluntarily provided to the CDC by actors at the state level, and is not comprehensive for
all potential agents of interest. However, such information can be used to inform policymakers as to “normal” levels of these agents in the wild, with large deviations from the
baseline serving as markers of abnormal occurrence. Through observing this data it
becomes clear, for example, that the Anthrax outbreak resulting from the introduction of
the disease into the US Senate offices in 2001 was a clear deviation from the norm.
Table 3.5. CDC Disease Outbreak Data on Observed Infectious Diseases: 2001-2004
2001
2002
2003
2004
Total
Anthrax
Botulism,
Foodborne
Botulism,
Other
Brucellosis
Cholera
23
2
0
0
25
39
28
20
14
101
116
90
109
124
439
136
125
104
114
479
3
2
2
5
12
Encephalitis,
western
equine
66
2840
2866
1142
6914
Plague
Tularemia
2
2
1
3
8
129
90
129
134
482
Monitoring and surveillance of disease can be improved past current capabilities.
Voluntary reporting by state agencies may not be the preferable solution in order to
gather information in a timely manner. Emerging infectious diseases such as Marburg or
Nipah, or eradicated diseases such as smallpox, may be incorrectly identified initially at
the local level whereas an aggregate view of disparate data from numerous states may
indicate that an outbreak is taking place. Nevertheless, monitoring and surveillance
provides a continuous background against which new information can be validated for
deviance from a trend.
35
4.
BUSINESS DEVELOPMENT
4.1. METHODS TO ENCOURAGE TECHNOLOGY DEVELOPMENT
The Federal government uses a variety of methods to encourage technology development.
Each federal agency involved in research and development approaches the topic slightly
differently, but most agencies use either grants or contracts. At some Agencies, such as
the NIH, a large portion of the research is investigator-initiated based on broad
solicitations on a given topic. Other Agencies, such as the DOD or the DHS, tend to use
contractual agreements that originate from solicitations that include specific milestones
and deliverables.
One common method for funding research and development is the NIH R01 Grant.
These are investigator-initiated grants along a given topic line. The National Institute for
Allergy and Infectious Disease uses the NIH parent R01 (PA-07-070), generic to all of
the National Institutes, and does not use a specific solicitation to handle R01 Grants on
biodefense topics, although they do have a separate R01 for non-biodefense related
emerging infectious diseases (PA-07-246). However, there is a specific P01 grant, or
“program project” grant, for multi-investigator research in the area of biodefense. All
grants over $500,000 per year must be approved by the NIH prior to submission.
Review of NIH grants is conducted via peer review. A council of experts on a given
subject is convened by the NIH several times throughout the year to discuss proposal
submissions in a “study section”. At study section, three reviewers, a primary,
secondary, and tertiary reviewer each provide an overview of the merits and drawbacks
of a program vis a vis current progress in the field. The panel then assigns a score to the
proposal, and proposals are funded based on these scores. Typically, an investigator can
expect to wait up to eighteen months following submission of their application prior to
hearing back from reviewers. Responses are generally detailed, and provide areas for
improvement should the investigator be interested in resubmitting. Information on
membership of various study sections is available to the public, and study sections can
either be standing or convened due to special emphasis in a given area.
Separate from grants, the NIH also funded three contracts in FY2006 in the area of
biodefense for a total of 129.72 million dollars. These contracts were for the specific
development of therapeutic strategies for Category A, B, or C biological threat agents
(Table 4.1).
36
Table 4.1. Three Biodefense Contracts
Proposer
SRI International
Alnylam Pharmaceuticals
NexBio, Inc.
Topic
Services for Pre-Clinical
Development of
Therapeutic Agents
Development of
Therapeutic Agents for
Select Viral Diseases
Development of
Therapeutic Agents for
Select Viral Diseases
Amount (Millions)
56.89
23.02
49.81
The DOD and DHS, on the other hand, prefer contractual mechanisms to grants as their
research and technology development portfolio tends to be objectives and mission-driven.
A variety of DOD and DHS agencies contract out for research and technology
development in biodefense, and most contracts are awarded through the Broad Agency
Announcement (BAA) process.
In FY2006, several BAA calls relevant to biodefense were open for submission. These
included:

The second phase of a DHS program to develop assays and informatics
systems capable of detecting biological threat agents (HSARPA
BAA 06-01)

A biological weapons countermeasures program for accelerated
development of medical therapeutics (DTRA BAA 06-01)

Methods to diagnose an individual infected with a pathogen prior to
emergence of symptoms (DARPA BAA 06-19 Addendum 4)

The Medical Chemical and Biological Defense Research Program (Joint
Science and Technology Office for Chemical and Biological
Defense USAMRMC BAA 06-01 Supplemental)
These contracts are often performed phase by phase, with individual phases rarely
exceeding two years. However, few BAA solicitations provide guidelines for total
budget amounts, and it is up to the sponsoring agency to determine whether or not the
applicant has appropriately rationalized their proposed budget. Unlike NIH grants, which
go through a process of peer review, BAA proposals are reviewed by governmentemployed experts from a variety of fields and agencies.
37
In addition to grants and contracts, the federal government also uses Small Business
Innovation research (SBIR) and Small Business Technology Transfer (STTR) awards in
order to administer R&D funds to encourage small-business growth as well as
cooperation between academia and the private sector. By statute, two-and-a-half percent
of all federal funding for extramural research is earmarked for SBIR programs. An
additional three-tenths of a percent set aside for STTR programs which involve
cooperative agreements between academia and industry.
The SBIR program is authorized until September, 2008, by the Small Business
Reauthorization Act of 2000 (P.L. 106-554), and P.L. 107-50, the Small Business
Technology Transfer Program Reauthorization Act of 2001, authorizes the STTR
program until 2009. These programs are often high-risk high-reward programs that
larger companies may not be agile enough to engage in. Awards are set at $100,000 for
the first six to twelve months of performance, with a potential second phase of up to
$750,000 over two years. Proposers can also apply for a third, unfunded, phase specific
for application/commercialization.
Examples of SBIR and STTR development projects related to Biodefense include:

An in-situ gelling nasal vaccine delivery platform (NIAID, awarded to
Delsite Biotechnologies, Inc.);

Microfluidic Controlled Gel-Drop Microarrays for Biothreat Diagnostic
Devices (NIAID, awarded to Akonni Biosystems, Inc.);

Chem/Bio Sensor Network Design Tool (SNDT) (DHS, awarded to
Applied Nanotech, Inc.);

A Computational Framework for Interpreting Metabolomics Data (DOE,
awarded to Genomatica, Inc.);

TIGER Biosensor for Broad Viral Detection and Genetically Engineered
Microbes (DOD, Isis Pharmaceuticals)
4.1.1. Regional Incentives
The most prominent regional development is done through the CDC's EWIDS program
(see Section 2.1.3). This program funds biosurveillance capabilities for states at the U.S.
Canada and U.S.-Mexico border. Further funding is available through the CDC's
cooperative agreement program for U.S.-Mexico border states.
In addition, the NIH funds ten Regional Centers of Excellence for Biodefense and
Emerging Infectious Diseases Research. An initial eight institutions shared 350 million
dollars in funding over eight years beginning in 2003. They included: Duke University,
Harvard Medical School, New York State Department of Health, University of Chicago,
38
University of Maryland, University of Texas Medical Branch (Galveston), University of
Washington and Washington University in St. Louis. In 2005 the University of
California, Irvine, and Colorado State University, Fort Collins, were added and received
80 million dollars in four-year grants. Regional coverage can be seen on Figure 4.1.
Figure 4.1. Regional Coverage by NIH Centers of Excellence
The mission of the Regional Centers of Excellence is to provide research on Category AC pathogens (see Section 3.1) and specifically to:
•
Support investigator-directed research
•
Train researchers and other personnel for biodefense research activities
•
Create and maintain supporting resources, including scientific equipment
and trained support personnel, for use by the RCEs and other researchers
in the region
•
Emphasize research focused on development and testing of vaccine,
therapeutic and diagnostic concepts
•
Make available core facilities to approved investigators from academia,
government, biotech companies and the pharmaceutical industry
39
•
Provide facilities and scientific support to first responders in the event of a
national biodefense emergency
4.2. STANDARDS DEVELOPMENT
In biodefense, a number of agencies have developed standards in terminology, to ensure
that discussion is conducted with a similar set of principles, standards in quality of
biological agent, to ensure that countermeasures are efficacious against a given pathogen
threat, standards in bioassays, to ensure that detection and verification methods for threats
are similar, and standards in product development, to ensure that treatments are both
functional and safe. Standards in categorization of bio-agent according to threat are
composed by the CDC and are discussed in Section 3.1. Standards in quality of pathogen
countermeasure and bioassays used for threat detection are discussed below in Section
4.2.1 on DOD assay development. Standards in product development are controlled by
the FDA, discussed in Section 2.1.5. Finally, the importance of standards was underlined
in a recent report by GAO (Section 4.2.2).
4.2.1. Case Study: DOD Standards Development in Assays
One set of standards applicable to commercial research and development is used by the
Department of Defense in regular operation of biodefense laboratories. These standards
are developed not for agent identification and classification, but rather for construction
and development of assays used in detection of bio-agents. The majority of the
biological detection assays are manufactured by a disparate group of DOD labs
underneath a joint directorate, the Chemical Reagents Program. CRP kits were used to
identify the Anthrax used in the attacks on the US Senate in Oct of 2001 as well as the
ricin toxin deployed against the Senate in 2004.
Prior to September 11th there was a low need for these assays DOD-wide. They were, in
essence produced in low quantities on a relatively as-needed basis. As the threat of
bioterrorism went from an on-the-horizon threat to a current and continuing threat,
several laboratories began producing assays for stockpile. However, different labs
produced different types of assays, without a uniform-standard developed. Each armed
service operated independently of the others to set criteria. Each lab collected data and
established benchmark metrics on their own per the demands of their “customer”, the
service which they were attached to.
In response, the DOD conducted a total overhaul of the system of development and
acquisitions. Rather than focus on development on a service by service basis, the DOD
organized production of assays into six core areas. Data relevant to the development of
these assays was standardized across the services under a 12.4M fund managed by the
Defense Threat Reduction Agency (DTRA). Development of standard criteria would
also inform the transition of some bioassay development into the commercial realm
through the Joint Biological Agent Identification and Diagnostic System, which would
40
manage deployment of FDA approved devices for DOD use. By unifying data across
laboratories it will be easier for DOD labs to identify gaps that can be covered through
commercial development, or for which off-the-shelf technology options do not exist.
Moreover, DOD labs now work from a shared set of cell cultures. All laboratories
receive portions of batches of biological agents in order to control the number of
unknown factors. Information on each cell line is used to supplement repositories of
information on characteristics of threat agents such as the Genomics Repository in
Washington, DC (DNA/RNA information) and the Antigen Repository in Utah (inactive
agent repository). These repositories provide information that allows researchers in
academia and private firms to conduct research on biothreats without a need for direct
access to the bioagent.
Lessons learned from this process were presented to other government agencies,
including the US Department of Agriculture, the Department of Homeland Security, and
the National Institutes of Health. The Department of Homeland Security and the
National Institutes of Health also use CRP-generated reference materials. Some of the
lessons included the need to standardize language and create memorandums of agreement
between researchers which allowed them to maintain control over the IP. An additional
area of concern was the ability to replicate results generated by the CRP, as difficulties
arose in verification of characteristics or detection of bioagents when the threat agent was
compromised by various additives.
4.2.2. Case Study: DHS Anthrax
In May of 2006, the GAO published a comprehensive report analyzing the ability of the
Department of Homeland Security to respond to the threat of Anthrax. An 877.5M
contract was put out in 2004 by DHS in order to acquire 75 million doses of vaccine. As
of 2006, the vaccine produced was inadequately tested and studied.
The GAO pointed out that to that point there were no standards regarding optimum
number of doses, no studies of long-term effects, and minimal data on short term
reactions. Further, there was no single standard model for determining the presence of
anthrax contamination. Overall, the GAO recommended that the Department of
Homeland Security establish a clean roadmap that delineated specific interagency
responsibilities and the contribution that individual agencies would provide to anthrax
detection and vaccine validation.
4.3. PUBLIC-PRIVATE PARTNERSHIPS
In 2004, the U.S. Congress legislated the creation of Project BioShield in order to acquire
and develop vaccine stockpiles in response to potential biological threats. This program
authorized 5.593 billion dollars of funding for the acquisition of vaccines for a range of
biological threats. Out of this total authorization, 3.418 billion was obligated for
41
FY2004-FY2008. A portion of this funding was used in development of the Anthrax
vaccine that the GAO found to be inadequate (previous section).
When interviewed, one problem cited by researchers was that Project BioShield did not
appropriately account for the risk that pharmaceutical companies are exposed to during
the development process. The government essentially provided funding for the
acquisition of vaccine through Project BioShield, and for development of vaccines at
early stages through other funding opportunities administered by agencies such as
NIAID, DTRA, or DARPA. The government rarely provided funding during clinical
trials, a period at which pharmaceutical companies can pay over $26,000 per patient
enrolled. This provides a disincentive for companies to provide new and more
efficacious vaccines, and can result in stagnation in vaccine development for emerging
pathogens.
In 2005, Dr. Philip Russell, former Army Medical Corps Officer and senior advisor to the
Department of Health and Human Services from 2001 to 2004 on acquisition of medical
countermeasures testified as to the shortfalls of the BioShield legislation in
countermeasure capacity building. While he recognized the important initial
accomplishments of the NIAID in basic research on countermeasures, he stated:
“Whether the potential products are eventually developed depends on
whether funding is available for industrial product development to the
point where they are considered viable candidates for a BioShield
acquisition.”
Continuing, he highlighted that most of the products in the acquisition process under
Project BioShield had received government funding through mid-level development and
observed that:
“When adequate government support of early and mid level development
is lacking, products will not progress to the point where they can be
purchased under BioShield. The present process does not fully meet the
needs of the government as evidenced by the slow development of anthrax
treatment products to the point where they are eligible for BioShield
procurement. Most small biotech companies with promising products need
government support in the preclinical and early clinical phases of the
R&D. Many large companies need government funding to share the risk of
initial development for products where the government is the only market.
This transition between laboratory research and early industrial
development is one of the more serious and controversial problem areas
in the current federal program for developing and acquiring medical
countermeasures.”
Recognizing the shortfall between intent and action, in December 2006, Congress made
changes to the acquisition process for vaccines and created the Biomedical Advanced
Research and Development Authority (BARDA). BARDA would be able to serve as a
42
venture capitalist, of sorts, and could fund the development of vaccines between initial
research and procurement, which occurs at the end of clinical trials. By doing this, the
federal government would be able to limit the potential risks in development for
commercial firms. While providing the funds up front increases risk to the federal
government, there would also be stringent reporting and oversight requirements.
4.4. TRADE COMMITTEES AND ORGANIZATIONS
Several standing bodies advise the U.S. government on trade issues. One of these is the
Industry Trade Advisory Center (ITAC) comprised of several Advisory Committees each
dealing with a section of industry (sixteen plus one committee of the sixteen committee
chairs). The system of ITACs are jointly administered by the Department of Commerce
and the United States Trade Representative (USTR). The ITACs provide a public-private
forum to ensure industry has a voice in formulating the trade policy of the United States.
They act as a mechanism to allow stakeholders in a given industry direct input on
legislation and trade agreements that may positively or adversely affect them. The
industry advisors serving on the ITACs provide valuable input as the Administration
advances its trade agenda to improve economic opportunities for America’s businesses,
workers, and consumers. ITAC 3 represents the Chemicals, Pharmaceuticals, and
Health/Science Products and Services.
Moreover, a number of experts on chemical and biological defense work outside the
government in non-profit organizations. Some of these organizations advise on matters
of policy, others represent professional or academic interests. Table 4.2 lists of some of
the major organizations with involvement in biodefense and biosecurity, along with brief
descriptions of their major policy focus.
Table 4.2. Major Non-Governmental Organizations Involved in Biodefense and
Biosecurity
Organization
American Society of
Microbiology
The National Academies
Arms Control
Association
Center for Arms Control
and Non-Proliferation
Type
Academic association
Activity
Professional education, workshop
and conference organization,
standards governance and journal
publication
Academic Organization Brings together committees of
experts. Engaged in broad array of
counter WMD studies in the area of
biodefense
American NGO
Promotes public education and
research on arms control policies
American NGO
Program on Biological and
Chemical Weapons Control and
Scientists Working Group reinforce
43
Center for Strategic and
International Studies
norm against development of
chem/bio-weapons and enhance
prevention and defense through
working papers, policy
recommendations, and briefings to
Congress
Biotechnology and Public Policy
Initiative: seeks to clarify
intersections of science and policy
to increase benefits and avoid
dangers.
American NGO
Homeland Security Program:
Advance policies, practices,
partnerships to keep America safe
and secure at home and abroad
Research organization with focus
on chem/bio-defense.
Chemical and Biological
Weapons Control
Institute
Council for Responsible
Genetics
American NGO
American NGO
Public education about social,
environmental, educational aspects
of genetics. Biowarfare program
works to end development and use
of bioweapons as well as research
for defense purposes that could
have offensive applications
Federation of American
Scientists
American NGO
Henry L. Stimson
Center
American NGO
Mitretek Systems
American NGO
Organization of American scientists
chiefly concerned with security and
non-proliferation issues. The
Biological and Chemical Weapons
Security Project seeks to raise
awareness among scientists of their
ethical responsibilities and potential
misuse of their research
Analysts with national security
focus. Chemical and Biological
Weapons Nonproliferation and
Response Project is concerned with
WMD capabilities, counter-WMD
capabilities, proliferation controls,
and likelihood of deployment
National center of expertise on
chemical/biological defense
systems. Supports US Armed
Services in disposal of stockpile
44
National Memorial
Institute for the
Prevention of Terrorism
American NGO
Potomac Institute for
Policy Studies
American NGO
RAND Corporation
American NGO
Trust for America’s
Health
American NGO
American Association
for the Advancement of
Science
British-American
Security Information
Council
International NGO
Carnegie Endowment
for International Peace
International NGO
International Coalition
of the Red Cross
International NGO
Nuclear Threat Initiative
International NGO
International NGO
45
Founded in wake of Oklahoma City
bombing. Funded by Congressional
appropriation. Conducts research
on social and political causes of
terrorism and the development of
counter-WMD technologies
Promotes discussion and debate on
key issues. In the area of biodefense, the Institute holds
numerous workshops and publishes
their findings
Research and advisory role on
scientific and technological issues.
Specific expertise in security policy
Public health advocacy
organization. Specific policy
recommendations relevant to biodefense
Advocacy on behalf of science in
the public interests
Independent analysis and advocacy
on global security issues; strategic
goal of bioweapons program is to
“increase public awareness in the
United States and Europe of the
problems and dangers of
bioweapons proliferation and the
opportunities for developing
national, regional, and global
responses”
Non-proliferation project that
provides authoritative information
on WMD proliferation
ICRC initiative on Biotechnology,
Weapons, and Humanity seeks to
reduce risk of biotechnology being
used against humanity. Seeks to
educate public as to risks, rules, and
responsibilities related to scientific
advancement
Global Health and Security
Initiative primarily focused on areas
of disease surveillance, early
detection, and rapid response as
well as promoting science security
Pugwash Conferences
International NGO
The Sunshine Project
International NGO
Alfred P. Sloan
Philanthropic
organization
Philanthropic
Organization
John D. and Catherine
T. MacArthur
Foundation
Ploughshares Fund
Philanthropic
Organization
American Biological
Safety Organization
Association of Public
Health Laboratories
Professional
association
Professional
association
Infections Diseases
Society of America
Professional
Organization
International Council for
the Life Sciences
Professional
Organization
Promotes meetings between
military and scientific communities.
Specific aim is to prevent
catastrophic threat from WMDs
Non-proliferation through public
education. Seeks to strengthen
international agreements and bolster
norms against deployment and
development of bioweapons
Program area in bioterrorism
Funds a Science, Technology, and
Security Initiative in counterproliferation and mitigation of
WMD threat
Supports efforts in non-proliferation
as well as improving security of
existing dangerous chemicals and
pathogens, standards creation for
responsible research, international
conventions against chemical and
biological weapons, destruction of
existing stockpiles, and reduction of
risk created by research for biodefense
Advocacy and education for
biosafety professionals
Advocacy and collaboration
between public health laboratories;
focus on preparedness
Represents scientists, clinicians,
physicians involved in the study or
treatment of infections disease.
Lobbying organization capable of
mobilizing 7,500 members
Represents scientists with interests
in the life sciences. Seeks to
promote global health and security.
Identification of risk and standards
setting.
Representation is not limited to professional organizations, academic organizations, or
public advocacy groups. In addition, commercial firms can hire professional lobbyists in
order to influence decision-making in the area of biodefense. Of these lobbying firms,
the most notable is McKenna, Long and Aldridge (MLA). McKenna, Long, and
46
Aldridge offer comprehensive services for clients interested in government access, with
capabilities ranging from scientific advisory to legislative action and cost proposal
analysis.
McKenna, Long, and Aldridge have been involved in numerous procurement and grantmaking processes. For instance, MLA has negotiated 98 million dollars in funding to
develop cell-based vaccine for pandemic flu, and expanded their business for that client
to 200 million in further treatment for SARS and general pandemic preparedness. They
have negotiated 3.4 million dollars from the NIH for construction of a new biodefense
laboratory. McKenna, Long, and Aldridge has been actively involved in crafting the next
stage of legislation on the BioShield effort. MLA associates frequently testify before
congress on biosecurity and biodefense issues. In addition, they leverage their network to
bring venture capitalists into the development process, providing transition partners for
government-sponsored research.
Further, MLA serves as an international liaison for various governments and overseas
businesses. MLA has extensive offices in Canada and represents several EU-biodefense
firms interested in blood product substitutes and vaccine development. They also liaise
to the media, and MLA associates are experts for major television news networks and
newspaper and print media.
Organizations such as MLA wield tremendous influence across sectors of American
business and public life. They can craft the public debate through media access as well
as negotiate specific contracts. They testify before Congress as experts, and at the same
time, lobby for the interests of specific clients in authorization bills. The role of lobbyists
in the American political process is pervasive, and McKenna, Long, and Aldridge
illuminates the extent of this practice in the biodefense and biosecurity policy area.
47
5. PROCUREMENT
5.1. HOMELAND SECURITY CONTRACTING METHODS
The Department of Homeland Security was only created in 2003 as an amalgam of
Agencies which previously existed under other branches of the executive government.
Because each of the constituent parts imported their own culture and way of doing
business when they joined DHS, the Department has yet to create a distinct culture.
The Department of Homeland Security was seen as a showcase for more efficient
government practices. The Department sought expediency and flexibility through
bringing modern business practices to federal bureaucracy. It has had, however, to
confront the different cultures of its constituent parts.
In response to the Global War on Terrorism, Agencies involved in Homeland Security
have been given additional acquisition authorities outside of the standard competitive
acquisitions process. Both the Homeland Security Act (P.L. 107-296) and the Defense
Department Authorization Act of 2004 (P.L. 108-136) increase the maximum award
allowable under a non-competitive contract and increase the micro-purchase maximum
for essential capabilities building activities. By simplifying the process, bureaucratic
oversight is reduced.
One addition to the Department of Homeland Security’s capabilities is the IndefiniteDelivery Indefinite-Quantity (IDIQ) contract. These contract vehicles allow for an open
line between the Department of Homeland Security and a proven performer outside of the
regular procurement process. If DHS has an IDIQ with a given performer and would like
to expand their statement of work to allow for additional material, more labor hours, or
increased services, it can add additional funding onto the contract and modify the
statement of work accordingly. There have yet to be any IDIQ awards by DHS
specifically for work relating to biodefense.
The biggest change in contracting methods used for biodefense was the establishment of
Project BioShield. Prior to 2001, there were few commercial opportunities for marketready vaccines for CDC Category A threat agents (Chapter 3), as the majority of them
were relatively unseen in the United States. Smallpox, for example, had been eradicated
from the United States for several decades. Federal Acquisition Procedures for
procurement required that biological countermeasure purchases be limited to $100,000
increments and undergo full and open competition. Commercial companies were
discouraged from making major research investments without a clear pathway to market.
48
Project BioShield relaxed many elements of the acquisition process and implemented
mechanisms to assist companies developing necessary countermeasures:

Increases of contract award under simplified acquisition procedures from a
100,000 dollar to a 25 million dollar ceiling

Expedited peer review in awards of 1.5 million or less by approval of the
Secretary of Health and Human Services

Guaranteed path to market and acquisition to the Strategic National
Stockpile eight years prior to commercial readiness in cases where the
Secretary of Health and Human Services and the Secretary of Homeland
Security find a concurrent need for a product
In addition, rather than year-to-year appropriations by Congress, appropriations under
Project BioShield are guaranteed until Congress decides to rescind funding.
Although it has encouraged some development activities, Project BioShield has come
under criticism since the legislation was enacted for not going far enough to encourage
research and development. Critics have alleged that it does not adequately shield
companies from litigation, should a therapy be approved for emergency use or be
acquired before fully tested through emergency measures and deployed in response to a
threat pathogen. In addition, Project BioShield does not fund basic research, nor does it
fund high-risk, high-reward research of the type engaged in by entities such as DARPA.
Recently, the Pandemic and All-Hazards Preparedness Act (S. 3678) was signed into law.
This bill establishes several new mechanisms for the acquisition of biological threat agent
countermeasures. For more information on estimated outcomes of the Pandemic and AllHazards Preparedness Act, please see discussion in Chapter 6.
5.2. PROGRAM MANAGEMENT AND OVERSIGHT
Program management and oversight differs from agency to agency and varies according
to the type of program and the mechanism of funding. Contracts are generally reviewed
regularly, with performers required to submit monthly or quarterly reports. Grants are
generally reviewed on the completion of the award period if the performer is seeking
additional funding. Cooperative agreements are continually monitored to assess whether
or not partners with the federal government, such as the states and municipalities in the
case of CDC’s programs, are meeting their obligations.
In research and development contracts and SBIR awards, performers must typically
demonstrate the ability to meet benchmark milestones in order to receive continued
funding. In a high-risk research and development agency such as DARPA, programs
which do not meet early milestones are terminated in their first phase with no opportunity
for additional funding. At other agencies, such as Homeland Security, the need for
49
capability building may allow for performers to slip on milestones as long as they deliver
a completed product.
However, the DHS has come under repeated scrutiny for allowing abuse and waste
through a lax oversight process that relies heavily on mechanisms outside of the normal
full competition process. In 2003, when DHS was created, 655 million of 3.5 billion
dollars in total contracts were awarded outside of the full competition process. By 2005,
this amount had increased to 5.5 billion out of a total pool of 10 billion dollars in funding.
In addition, DHS was accused to have major problems in its contracting organization,
frequently losing files and, in some cases, approving contracts with unjustified cost
proposals. While some of these problems stem from the fact that the DHS is an
amalgamation of new programs and previously existing agencies, major reform is often
argued to be necessary, and DHS officials have recognized the need to implement change
in their oversight processes. Project BioShield is operated through fixed-price contracts,
so there are no opportunities for overruns that typify some other major acquisitions.
In addition, there is a standard oversight process across all Federal Agencies. Internally,
Federal Agencies have an Office of Inspector General, responsible for auditing programs
and attempting to reduce waste. Externally, agencies are responsive to the Office of
Management and Budget (OMB) and the Government Accountability Office (GAO).
Additionally, there is Congressional oversight through the budget process and subpoena
before committee or subcommittee.
The Office of Management and Budget operates a standards and metrics program known
as Program Assessment Rating Tool (PART) that measures how various government
programs are performing. Programs are rated as:
•
Effective (well-managed, will approve efficiency)
•
Moderately effective (ambitious goals, well-managed, need to improve
problems with efficiency or design)
•
Adequate (need to develop more ambitious goals, improve accountability,
or strengthen management)
•
Ineffective (unable to achieve results due to lack of clarity regarding
program purpose/goals, poorly managed, or some other significant
weakness)
•
Results not demonstrated (unable to develop acceptable goals or collect
performance data).
Assessed programs must then create action plans on how to improve performance
regardless of what performance category they were placed in.
In 2006, the OMB evaluated the Department of Homeland Security’s Preparedness and
Medical Coordination program using PART and found that results could not be
determined for a variety of reasons. While the Program received a high score on purpose
and design (meeting eighty percent and eighty-three percent of benchmarks), the program
received poor scores on strategic planning and program results and accountability
(scoring thirty-eight percent and twenty percent respectively). The Program was
determined to be well designed and free of flaws, but it was unclear whether activities
50
under Project BioShield were directed at problems of greatest threat, risk, or
vulnerability. In addition, the Program was said to lack ambitious targets and specific
annual performance measures and did not establish baselines for performance. Individual
evaluations were not occurring in sufficient scope or quality and budget requests were
independent of program goals. The Program was determined to not demonstrate
adequate progress in achieving these goals both annually and in the long-term, and was
not demonstrating efficiency or cost effectiveness.
The GAO conducts similar audits of program effectiveness, although where the OMB has
a tendency to be focused on efficiency vis a vis the bottom line, the GAO evaluates
programs for responsiveness to the public good. The GAO Strategic Plan outlines its
aims and strategic goals. In the area of biodefense, these include:

Assessment of federal homeland security management, responsibility,
effectiveness, and achievement of mission goals;

Identification of means to strengthen strategies related to homeland
security and implementation;

Evaluation of homeland security resource priorities, costs, and approaches
to stimulate investments;

Assessment of effectiveness of U.S. and international efforts on nonproliferation of WMD technology
Through repeated assessment of federal capabilities against these strategic goals, the
GAO assists law-makers in identifying gaps in current implementation of programs by
the executive agencies.
5.3. HISTORY OF FUNDING DISTRIBUTION ACROSS FEDERAL
AGENCIES
Funding for biodefense and biosecurity has steadily increased since FY2001 as the nation
attempts to build capability to countermeasure potential biological threats. Funding grew
rapidly as programs initially were implemented, increasing over three-fold between 2001
and 2002. Research and development budgets for biodefense doubled between 2001 and
2002, and again between 2002 and 2003. Some agencies received single large influxes of
funds in order to deal with a specific threat, and the Department of Homeland Security
established itself as a cabinet level agency.
For the discussion in this section we draw on Chapter 2 and, in particular, Figures 2.1-2.3
and Appendix Figures A1.1-A1.6.
In FY2001, the majority (64%) of the 1.624 billion dollars for biodefense was allocated
to the Department of Defense. Procurement made up 470 million dollars of DOD’s
51
activities, and Research and Development comprised 522 million dollars of the
remainder. The DOE allocation of 46 million dollars was expended by the National
Nuclear Security Agency programs. The 175 million dollars allocated to the United
States Postal Service was entirely spent on response to the Anthrax attacks of the fall of
2001. Of the State Department’s 39 million, 35 was spent on counter-proliferation
efforts. DHHS expended 80 million on public health response and preparedness, 53
million on NIH research, 182 million by the CDC to build the Strategic National
Stockpile, upgrade state, local, and CDC capacity, and basic and applied research.
In FY2002, the budget for biodefense had increased to 5.3 billion dollars and HHS
replaced DOD as the major recipient of federal expenditures. Approximately 1 billion
dollars of the total 2.98 billion was allocated to the CDC to improve stockpile capabilities
for Anthrax and smallpox. In addition, the CDC expended 940 million through the
cooperative agreement program to improve state and local preparedness. The research
budget of NIH quadrupled, from 53 to 198 million. Expenditures at the FDA for food
safety and defense increased from 1 million to 98 million. Also notable in 2002 is the
587 million received by the United States Postal Service in order to improve protection
and screening capabilities. Last, the USDA expended 143 million to develop a
biohazards laboratory at Ames, Iowa.
In FY2003, the Department of Homeland Security received its first allocations for
biodefense. While exact budget numbers are unclear, it is estimated that the DHS
expended approximately 114 million dollars on biological countermeasures. The budget
for biodefense at HHS increased by another billion dollars, while the NIH was the
recipient of 1.5 billion dollars for biodefense research, a five-fold increase from the
previous year. NIH spent 373 million dollars on the construction of extramural facilities
and another 370 million on improving internal security. The CDC’s expenditures on the
Strategic National Stockpile and development of smallpox countermeasures were cut in
half, and this was the last year that smallpox received a supplemental appropriation. Year
2003 marks the beginning of budget transparency for the cooperative threat reduction
program by the Department of Defense and the program received a three-fold increase in
biodefense non-proliferation funding.
In 2004, the Department of Homeland Security received slightly more funding for
biodefense than the Department of Defense. The Department of Homeland Security
received a 480 million dollar appropriation for the Federal Emergency Management
Agency (FEMA). Project BioShield began in 2004 allocating an additional 885 million to
the Department of Homeland Security for acquisition of vaccines. In addition, 88 million
dollars was allocated for the development of NBACC, and 455 million was allocated for
biodefense research and development. The Department of Health and Human Services
had their first budget decrease for bioweapons funding since 2001, with specific cuts to
the Metropolitan Medical Response System, and a zeroing out of funding for extramural
laboratory development.
In Fiscal Year 2005, the overall budgets of the Federal Agencies and the programs which
funding was allocated to remained relatively static. The decrease in the DHS budget for
52
2005 was largely due to a decrease in acquisition activities through Project BioShield.
The United States Postal Service received another allocation for screening and
prevention. The CDC re-established control of the Strategic National Stockpile in 2005,
after an experiment with Department of Homeland Security oversight the previous year.
In addition, the budget for biodefense at FEMA decreased to 63 million after initial
capacity building. The Department of Health and Human Services resumed funding for
extra-mural laboratory construction with approximately 150 million dollars in funding.
Installation force protection, hardening military bases to a bio-weapons attack, received
an initial 105 million in DOD funding.
In Fiscal Year 2006, the Department of Homeland Security expended 870 million dollars
through Project BioShield. Funding for biosurveillance initiatives at the CDC increased
from 79 million in FY2005 to 133 million in FY2006. DOD funding for installation
force protection nearly doubled, receiving 202 million dollars. In addition, DOD basic
research in biodefense increased from 52 million in 2005 to 94 million in 2006.
While no formal budget was passed in 2006, continuing resolutions for 2007 placed most
federal agencies at approximately the same levels of programmatic funding for FY2007
as they were for FY2006. The most major changes to 2007 estimated budgets were in
installation protection by the DOD, where funding was cut in half, and a 176 million
dollar increase in Project BioShield funding.
5.4. STATE FUNDING
In FY2002, the CDC budget for state and local programs to ensure preparedness in case
of a bioterrorism attack increased from 49.9 million dollars to 918 million dollars, a
nearly twenty-fold increase. These funds were allocated to states for research and
development, build-up of necessary infrastructure and emergency response capability,
and training of medical personnel. The program was administered by the Centers for
Disease Control, which provided funding to the states and major municipalities and
served as a coordination center and clearinghouse for knowledge.
While this program, overall, was considered successful, large amounts of funding
provided to the states under the program were never expended or obligated. Out of nearly
one billion dollars in FY05 funds, 157 million remained unspent at the end of the period
(Tables 5.1, 5.2). A large portion of these funds were reclaimed by the CDC and
distributed to labs and other programs.
One possible explanation for the success of Kansas in obligating all of its allocated funds
can be derived from their metrics-driven approach to program administration. Kansas,
unlike many other states, utilized a CDC developed survey in order to measure changes
in preparedness from 2002-2003 and index capacity at the local and state levels. The
Kansas Health Institute worked closely with the Kansas Association of Local Health
Departments in developing priorities and appropriate levels of response to shortfalls.
53
Table 5.1. Unobligated Funds Awarded Under the Public Health Preparedness and
Response for Bioterrorism Program (HHS-CDC)10
State
Washington D.C.
Nebraska
Los Angeles
Oregon
Nevada
Chicago
New Hampshire
South Dakota
North Carolina
Indiana
Delaware
Vermont
South Carolina
Arizona
Louisiana
Texas
Maryland
Wisconsin
North Dakota
Illinois
Wyoming
Massachusetts
Alabama
New Mexico
New Jersey
New York
Pennsylvania
Mississippi
Idaho
Kentucky
Ohio
New York City
Rhode Island
Alaska
Tennessee
Minnesota
Colorado
West Virginia
Florida
Virginia
Michigan
Connecticut
Maine
Arkansas
Montana
Missouri
Oklahoma
Hawaii
Utah
California
FY05 Award11
$20,032,292
7,513,167
28,414,156
16,048,213
13,077,219
14,615,376
8,725,305
7,794,491
21,288,709
17,998,528
9,673,981
7,209,406
16,091,145
20,020,724
20,235,952
67,170,118
14,806,853
17,361,517
5,631,748
25,569,678
7,719,940
28,553,869
17,079,781
11,826,157
30,516,430
34,254,995
50,776,737
14,303,036
8,485,043
15,632,906
39,091,923
25,875,515
6,561,276
5,412,040
15,929,481
15,129,116
16,084,461
9,529,605
43,704,396
21,790,488
30,704,353
15,839,873
6,892,377
12,123,140
7,635,483
17,324,425
14,394,566
6,752,866
8,964,779
68,819,980
Unobligated Funds
$12,227,280
3,057,592
10,198,192
5,239,116
3,943,518
4,299,727
2,534,624
2,222,848
6,068,396
5,097,866
2,593,009
1,918,590
4,100,247
5,012,352
4,375,905
13,825,974
3,014,538
3,490,789
991,825
4,304,396
1,187,200
4,059,361
2,389,461
1,647,489
4,026,766
4,353,356
6,448,560
1,806,822
1,021,810
1,839,894
4,588,466
3,000,218
755,783
575,633
1,676,313
1,516,784
1,546,554
835,198
3,471,791
1,727,866
2,294,482
1,147,914
485,954
848,721
527,821
1,039,976
843,468
346,003
316,908
1,882,804
10
Percent Unobligated
61.0%
40.3
35.9
32.6
30.2
29.4
29.0
28.5
28.5
28.3
26.8
26.6
25.5
25.0
21.6
20.6
20.4
20.1
17.6
16.8
15.4
14.2
14.0
13.9
12.2
12.7
12.7
12.6
12.0
11.8
11.7
11.6
11.5
10.6
10.5
10
9.6
8.8
7.9
7.9
7.5
7.5
7.1
7.0
6.9
6.0
5.9
5.1
3.5
2.7
Audit of unobligated balances of funds awarded under the Public Health Preparedness and Response for
Bioterrorism Program. HHS Office of the Inspector General. December 2006.
11
Includes carryover from previous awards
54
Washington
Kansas
Georgia
Iowa
Total
19,684,947
9,504,019
***
***
$995,726,586
429,550
0
***
***
$157,125,715
2.2
0
***
***
15.8%
Table 5.2. States with the Highest Percentage of Unobligated Funds
State
Washington D.C.
Nebraska
Los Angeles
Oregon
Nevada
FY05 Award12
$20,032,292
7,513,167
28,414,156
16,048,213
13,077,219
Unobligated Funds
$12,227,280
3,057,592
10,198,192
5,239,116
3,943,518
Percent Unobligated
61.0%
40.3
35.9
32.6
30.2
The CDC commended the approach that Kansas took in administering these funds,
commenting on a report in Morbidity and Mortality Weekly Report, one of the CDC’s inhouse journals by saying:13
“While determining the optimal level of preparedness capacity for LHDs
[local health departments] in Kansas was not an objective of this study,
the findings suggest that when attention and funds are allocated,
preparedness capacity improves in specific and measurable ways.
Investments in such a critical field as public health preparedness should
be accompanied by consistent evaluation methods. For this purpose, CDC
is shifting attention from assessment of public health capacity to
evaluation of actual public health performance that can be expected as a
result of the increased capacity. These findings also demonstrate that
when the same measurable indicators are used repeatedly, important
information can be obtained regarding successes and areas in need of
further improvement.”
However, an HHS audit of the overall CDC program discussed shortfalls on accounting
practices on the state and federal level which led to many of the failures in ensuring that
funds were properly expended:14
“Although CDC had methods in place to monitor the obligation and
expenditure of funds, many awardees did not fully execute their
expenditure plans or submit timely financial status reports. Thus, CDC did
12
Includes carryover from previous awards
CDC. 2005. “Improvement in Local Public Health Preparedness and Response Capacity --- Kansas,
2002-2003,” MMWR WeeklyReport 54 (18): 461-462.
14
Levinson, Daniel R. 2006. “Audit of Unobligated Balances of Funds Awarded Under the Public Health
Preparedness and Response for Bioterrorism Program.” HHS Office of the Inspector General. December 5,
2006.
13
55
not always receive the information needed to encourage the expenditure of
funds and to minimize unobligated balances. In addition, CDC officials
did not offset (reduce) new- year awards by the amount of unobligated
funds carried over from the prior budget year, even though the
Department's "Awarding Agency Grants Administration Manual" (the
Manual) authorizes offsets. Although CDC is not required to implement
the Manual, the use of such offsets could have minimized unobligated
balances and made additional new-year funding available for awardees
with greater needs.”
The audit acknowledged that the CDC had since resolved many of the issues with their
own accounting practices, by standardizing guidance and oversight controls as well as by
allowing states to carry awards forward in order to offset new funding. While the CDC
has begun recommending reform since December of 2004, they agreed to implement the
major suggestions of the report in December of 2006.
Federal funding administered to states for public health preparedness related to
bioterrorism has continually decreased since the FY2005 budget (Table 5.3).
Table 5.3. Changes in Federal Funding for State and Local Bioterrorism Preparedness
FY 2005-2008 ($m)
FY2005
Actual funding
Bioterrorism
Cooperative
agreement
Centers for public
health
preparedness
Advanced practice
centers
All other state and
local capacity
Total
857,337
FY2006
Enacted
appropriation
760,470
FY2007
Continuing
resolution
761,008
FY2008
Proposed budget
698,267
29,425
30,699
30,690
0
5,424
5,342
5,346
0
26,692
26,618
26,630
0
919,148
823,099
823,674
698,267
These cuts alarmed public health advocacy groups, who were particularly troubled that
budgets for entire programs had been zeroed out. Richard Hamburg of the Trust for
America’s Health stated that:
"The reduction of the bioterrorism and public health preparedness
programs is particularly troubling. We are cutting core boots-on-theground support for emergency disaster response, leaving the country at
unnecessary levels of risk."
56
While the GAO had found improvements to state and local public health preparedness in
a 2004 study of programs conducted over 2002-2003, they had also asserted that more
work was yet to be done, as states were continuing to fall short of CDC program goals.15
Out of fourteen critical benchmarks, most states met four, the majority of states
demonstrated capacity to meet eight, but only a few states were responsive to the
remaining two.
Four critical benchmarks were met by most states:

Designation of an executive director of bioterrorism preparedness and
response program

Establishment of a bioterrorism advisory committee

Assessment of epidemiologic capacity and achievement of goal of one
epidemiologist for each major metropolitan area

Coverage of ninety percent of the population by the Health Alert Network
Eight critical benchmarks were met by a majority of states:
15

Assessment of emergency preparedness and response capabilities

Assessment of statutes, regulations, and ordinances that provide for
credentialing, licensure, and delegation of authority for executing
emergency measures

Development of interim plan to receive and manage items from the
Strategic National Stockpile

Development of a system to receive and evaluate urgent disease reports at
all times

Development of a plan to improve working relationships between clinical
and public health laboratories

Development of a communications system the provides for flow of critical
health information at all times

Development of an interim plan for risk communication

Preparation of a timeline to assess training needs
GAO 04-360R. 2004. “HHS Bioterrorism Preparedness Programs.” February 10, 2004.
57
Finally, two benchmarks were met by few states:

Development of a statewide incident response plan for incidents of
bioterrorism and emergencies and provisions for exercising the plan

Development of regional response plan across state borders for incidents
of bioterrorism
In discussing the efforts with state officials, the CDC was able to determine that key areas
of concern were:

Redirection of resources allocated to bioterrorism to the National
Smallpox Vaccination Program

Difficulties in increasing personnel as a result of state and local budget
deficits

Delays caused by state and local management practices
The GAO report concluded by stating that:
“Although states’ progress fell short of 2002 program goals, CDC’s and
HRSA’s cooperative agreement programs have enabled states to make
much needed improvements in the public health and health care capacities
critical for preparedness. States are more prepared now than they were
prior to these programs, but much remains to be accomplished.”
State and local programs have not undergone another formal evaluation by the GAO
since 2004. However, the budgeting issues in FY2004 and FY2005 allocations indicate
that there are still bureaucratic snags in the process. With a decrease to funding for
bioterrorism preparedness and response at the state and local level, it remains to be seen
whether states can meet the fourteen critical benchmarks.
58
6. FUTURE PLANS, TRENDS, AND
HOMELAND SECURITY OUTLOOK
6.1. STATE INVOLVEMENT: ILLINOIS – A CASE STUDY IN STATE
RESPONSE
The State of Illinois can be used as a model for a general state response to public health.
Illinois, demographically, is roughly representative of the nation in total. The state has
municipal and rural areas with distinct priorities, and the state government is not
dominated by a single party. Illinois has a public health agency that closely collaborates
with its emergency management agency, and a homeland security coordinator operates to
ensure optimal inter-agency coordination. In addition, the state public health agency has
been continually led by physicians with experience in the public health sector for the past
two decades, and the state public health agency is professionally operated as a result.
Furthermore, at the local level, ninety four independent health officials contribute their
expertise in jurisdictions that cover ninety nine percent of the state’s population.
The primary vehicle for state funding for public health and biodefense in Illinois is Local
Health Preparedness grants. These grants support preparedness at the community level,
and are based on population and need. In addition, Illinois receives funding from the
CDC for state and local public health preparedness. Prior to 2001, Illinois received
approximately one million dollars per year from the CDC, half of which was allocated to
the Health Alert Network, an information system, and a quarter of which supported the
development of public health laboratories.
Beginning in 2002, the CDC assigned Illinois thirty one million dollars for response to
bioterrorism, twenty seven million of which was allocated for public health preparedness
and response and 4 million allocated directly to hospitals. Chicago received an additional
thirteen million. Funding continued at these levels through 2006. These funds were
guided towards the critical benchmark areas discussed in Chapter 5.
Specifically, Illinois has used the funds to boost the following areas:

Preparedness Planning: Bioterrorism planning is conducted by the Illinois
Emergency Management Agency. Twelve Public Health Regional
Response Planning Areas of 250,000 people are overseen by emergency
response coordinators who are in charge of taking the lead on
implementing community and agency-wide response plans.
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
Surveillance and Epidemiologic Capacity: In 2003, Illinois developed INEDSS as a branch of the National Electronic Disease Surveillance
System. In addition, the state began to hire professional epidemiologists
to fill ten positions in large local health jurisdictions and twelve positions
in the state agency.

Laboratory Capacity: While the state has attempted to push for greater
development in identification of pathogens at the state public health
laboratory level, it is as of yet unable to fill all vacancies due to a lack of
qualified personnel due to a hiring freeze in the state budget. This is a
problem common to many states seeking to improve capacity, as state
budget priorities and federal benchmarks conflict.

Health Alert Network Development: Illinois attained complete coverage of
all public health jurisdictions by 2002.

Hospital Readiness: Hospital Readiness was a major focus of Illinois
officials. By 2002 they had implemented the Illinois Mobile Emergency
Response Team (IMERT), which began as an association of toxicologists
and emergency physicians in 1998. Currently, IMERT is made up of
trained teams from state police, the Department of Nuclear Safety, the
Illinois Environmental Protection Agency, the state health agency, and the
state emergency management agency. IMERT provides Illinois the
capability for indigenous mass decontamination following a chemical or
biological attack. In addition, this network is supported by the Mutual Aid
Box Alarm System (MABAS), which is a consortium of nine tenths of
Illinois fire departments linked to the state emergency plan through a
memorandum of understanding.
In addition, in 2004 Illinois developed the Illinois Public Health Mutual Aid System
(IPHMAS). This system enhances a network by which resources can be shared among
local public health departments in the case of a bioterrorist incident or other disaster.
IPHMAS was patterned after MABAS, and was the first agreement of the kind in the
country, although it had been under discussion for five years. While only thirty three of
the ninety five health departments had signed on in 2004, all public health departments in
the state had become members by late 2005.
In 2003, Illinois created a Department of Homeland Security to coordinate state strategic
planning in counter-terrorism and communicate information to the public. While Illinois
Homeland Security does administer grants, these grants are largely for law enforcement
and emergency personnel. The Illinois Department of Public Health does fund research
grants, but not in the area of bioterrorism, and preparedness funds are available only for
the addition of defibrillators to public schools, parks, universities, and colleges. This is
typical of state response, with a greater burden of interest placed on ensuring
responsiveness rather than conducting investigative research.
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6.2. NEW GOVERNMENT AGENCIES INVOLVED IN HOMELAND
SECURITY: THE PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT
As the Department of Homeland Security continues to assert its role in public policy
formation in the United States, new agencies and organizations are created to address
gaps in capability. In order to fill some of these gaps, the Pandemic and All-Hazards
Preparedness Act (S. 3678) was signed into law. The bill created an Assistant Secretary
position in the Department of Health and Human Services to specifically serve the area of
preparedness response. The bill also created the Biomedical Advanced Research and
Development Authority (BARDA) and its complement the Biodefense Medical
Countermeasure Development Fund, and the National Biodefense Science Board.
BARDA was created to address the shortfall in funding between vaccine discovery and
product development. The Biodefense Medical Countermeasure Development Fund
would serve as a funding source for BARDA’s activity. The National Biodefense
Science Board will serve in an advisory capacity to the Department of Health and Human
Services on specific biodefense issues.
The Pandemic and All-Hazards Preparedness Act reorganizes national public health
planning by authorizing the Assistant Secretary for Preparedness and Response to:

Serve as principal advisor to the Secretary on federal public health and
medical preparedness and response for public health emergencies

Be responsible for logistics, personnel, and supplies in the case of public
health emergency

Oversee development and procurement of countermeasures and
management of the Strategic National Stockpile

Coordinate public health and medical capabilities with state and federal
agencies

Provide leadership in international programs, initiatives and policies that
deal with medical preparedness and response and public health
The Act requires the Secretary of HHS to submit a National Health Security Strategy and
include an assessment of federal, state, and local public health preparedness. The act also
requires the Secretary to build capabilities at the state and local level for real-time
situational awareness in the event of a catastrophic disease outbreak and provides for a
pilot program to provide loan repayment for individuals who serve in a shortage area or
high risk area.
In addition, S. 3678 established BARDA as the single agency in the federal government
for research and development on civilian countermeasures to bioweapons. Specifically,
BARDA was charged to:
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
Coordinate activity to develop advanced research and development on
qualified countermeasures for pandemic and epidemic

Ensure collaboration between components of HHS, other federal agencies,
industry and academia

Promote advanced research and development of countermeasures or
biodefense related technologies

Facilitate interaction between the Food and Drug Administration and
interested commercial entities

Promote innovation which shortens development time for advanced
countermeasures
These activities will be supported by the Biodefense Medical Countermeasure
Development Fund, a 1.07 billion dollar fund that will carry funding from FY2006-2008.
The Biotechnology Industry Organization (BIO), a professional organization representing
biotechnology industry interests, recognized S. 3678 as an essential piece of legislation
for ensuring preparedness and addressing the concerns of industry, stating:
“This bill includes critical BARDA provisions and provisions to
reauthorize bioterrorism grants and is a necessary step toward improving
America’s defense against bioterrorism and pandemic diseases… This
legislation recognizes that the ‘Valley of Death’ remains a barrier to
effective countermeasure product development… Through BARDA,
contracts and grants for advanced research and development will be made
to companies working on products to protect the American people. The
bill also contains important contract reforms that improve upon the
advances made under Project BioShield, by allowing, for example,
milestone payments and surge capacity provisions to improve the viability
and sustainability of biodefense product development and manufacture.”
In addition to providing reform to components of Project BioShield, S. 3678 created the
National Biodefense Science Board to serve in an advisory role to the Department of
Health and Human Services. During his period as Secretary of Homeland Security,
Tommy Thompson established the National Science Advisory Board for Biosecurity. At
this point it is unclear whether this existing board, which has a mandate to guide
biosecurity development, will be replaced by the new National Biodefense Science
Board, or whether it will simply be renamed. Whereas the National Biodefense Science
Board serves in a specific advisory capacity, the National Science Advisory Board for
Biosecurity more generally provides standards to prevent misuse of scientific knowledge
and fosters collaboration for potential dual-use research.
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6.3. OTHER PLANNED ACTIVITIES
With major reform to the Project BioShield program, the 110th Congress is likely to
evaluate several issues of public health preparedness over the next two years:

Federal coordination: In the aftermath of Hurricane Katrina, it was
unclear how DHS and HHS managed their overlapping mandates to ensure
public health security. The 110th Congress will observe reforms to this
process established in S. 3678 to view whether additional legislation is
needed.

HHS Response Capability: With HHS’ scope of responsibility for
disaster management broadened, policy-makers will attempt to determine
whether more effective means can be established to fund disaster relief or
whether current methods are adequate. Currently, the emergency fund of
the HHS Secretary is empty. In addition, mental health counseling
response to disaster may also be investigated.

State Grants: HHS has yet to publish performance evaluations for
recipients of state preparedness grants. As these programs have been
broadened through S. 3678, Congress may become more inquisitive as to
management of these funds.

Biodefense Research and Development: With reform to Project
BioShield complete, Congress may become more interested in research
conducted at NBACC and through the NIH.

Isolation, Quarantine, and Mandatory Vaccination: Increasing threats
of serious pandemic may lead to Congress becoming seriously interested
in various aspects of managing pandemic threats. This could lead to
establishment of federal authority on emergency management in an area
where state and local government have taken the lead.

Rationing of Scarce Resources: In the case of an outbreak of an emerging
pathogen, the mobilization of existing resources may not be sufficient to
deal with a serious biological threat. Congress may need to consider
directing planning for prioritizing of insufficient quantities of
countermeasures.

Expiring Authorities: Program authority for the HHS Select Agent
Program, which deals with potential bioterrorism agents, expires in
FY2007. General program authority for the Strategic National Stockpile
was not extended in FY2006. HHS professions programs expired in
FY2002, and reauthorization may include language to support emergency
preparedness and response.
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6.4. EMERGING AREAS
As new pathogens emerge, governments must be prepared to detect and intercept these
threats. Avian influenza of the H5N1 strain could be an emerging threat in human
populations if the disease mutates to the point where it can pass between human hosts.
Currently, mortality rates for H5N1 when human hosts acquire it are on the order of
mortality rates from the Spanish influenza of 1918, which killed between fifty and a
hundred million people over an 18-month span.
In addition, the NIAID is interested in emerging and re-emerging pathogens, and have
recognized several pathogens discovered or rediscovered in the last two decades as
pathogens of interest for continued study. These include diseases such as Enterovirus 71,
first recognized in 1969 in Brazil. Enterovirus 71 has re-emerged in the last decade in
Asia, with cases found in Singapore, Vietnam, Malaysia, and Taiwan. Traditionally, the
disease travels through a fecal-oral route, but evidence seems to suggest that the latest
strain of the virus may transmit along respiratory pathways. Foreign incursion of serious
disease such as this could lead to rapid spread among a less resistant population.
Further, drug-resistant and treatment resistant bacteria continue to emerge. As bacteria
continue to struggle for survival, the ability to treat them with common antibiotics has
decreased. In a study which isolated Pseudomona aeruginosa between 2000 and 2004,
10.1 percent of all the bacteria isolated were resistant to a single therapeutic agent, while
4.3 percent were resistant to multiple treatment agents.16 If the mechanisms by which
bacteria evolve multiple drug resistance are better elaborated, persons interested in
producing biological agents may be able to leverage off of this. On the other hand, that
same knowledge could lead to capabilities to target pathways along which resistance is
developed when developing countermeasures.
Finally, better understanding of emerging diseases can lead to improved biosecurity and
biodefense. As many of the diseases that could potentially be used as threat agents are
rare in United States populations, detection methods for novel and emerging diseases will
also capture the anomalies presented by biological threats. In addition, capabilities of
mobilization of material and preparedness are essentially the same when dealing with an
unknown and emergent epidemic or an intentional bioterrorism agent.
16
Moniri, R., Mosayebi, Z., Movahedian, AH, and GhA Mossavi. 2006. “Increasing Trend of
Antimicrobial Drug-Resistance in Pseudomona aerudinosa Causing Septicemia,” Iranian Journal of Public
Health 35 (1): 58-62.
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7. CONCLUSION
The United States has invested heavily in improving capability to respond to biological
threats. However, almost six years after the anthrax incident in Congress, the United
States government has a patchwork approach to biodefense and biosecurity research and
development. While the federal government is making steps to unify disparate programs,
there is still a lack of total preparedness at the state and local levels.
There is not a standardized process for addressing biosecurity issues due to the following
factors:
•
There is a large set of government agencies at both the Federal and the
State levels that are tasked with parts of the job making coordination
within the public sector difficult.
•
The new Federal Agency mandated with a coordinating role (DHS) has
had ‘teething’ problems in the past few years. These problems are slowly
receding.
•
The public sector cannot handle the broad solution space on its own;
private sector ingenuity and technology is needed.
•
The private sector can engage in research and development of new
products (such as sensor systems or treatments for diseases) but they need
government funding.
•
Academia needs to be involved in both basic and applied research; as well
as support through training of personnel.
•
Other non-governmental organizations play a role in facilitating
interactions and coordination between these sectors: public, private, and
academic.
In order to ensure that all business and research is carried out towards common goals, the
government attempts to create universal standards. For instance:
•
Common strains of identified threat agents are available to researchers
with proper security clearances.
•
Therapeutics must conform to minimum standards of efficacy and safety.
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•
Assays and sensors for detection of pathogen should be calibrated to
detect specific levels of threat agent.
However, these standards have yet to be adopted by all researchers funded by the various
agencies.
It is as of yet unclear what the future benefits of the large US investments may be. At
least, stockpiles for emergency treatment in case of outbreak exist now that did not exist
in 2001. Currently, programs in the Federal government seek means to rapidly develop
and screen vaccines for safety and efficacy, to monitor millions of livestock for zoonotic
illness, to place sensor grids across metropolitan areas capable of providing early warning
of chemical and biological attack, and to detect disease in an individual before the
development of symptoms. Interagency cooperation and coordination across levels of
government still have room to improve, but policy-makers remain aware of potential
problems and seek rational means for their solution. Industry and academia are involved
at multiple levels, and the government seeks to actively partner with the private sector to
ensure successful outcomes.
With a greater understanding of the risks involved and the mechanisms that will need to
be implemented in case of a response, the federal government has attempted to improve
the quality of preparedness through guided funding. Equally important is ensuring that
response is prepared to the right types of biological threats. There are limited resources
available and the government is attempting to apply those resources in a more efficacious
and directed fashion. In addition, advanced research and development can assist in
attaining strategic advantage against those who would deploy a biological threat agent.
Procurement and oversight continues to be an area of concern for biodefense, and as
investments and acquisition move forward, the government will seek to balance disparate
needs. The government desires the ability to acquire developed and safe drugs without
having to pay for development costs. However, due to the low market need for some of
these drugs, they simply are not available at late-stage development.
Government programs in biodefense have traditionally been unsuccessful at creating and
achieving set milestones and metrics. In order to continue receiving high levels of
funding and ensure that the American people are receiving the appropriate level of
security for the funds expended, programs may need to implement more measurable
milestones and goals. A case in point is the CDC program which directs funding to states
under agreements where the state merely needs to indicate progress towards goals. Such
objectives may need to be reformed.
Finally, as new threats to biosecurity emerge, the government should be prepared to
detect and respond to them. Unifying leadership on pandemic preparedness and funding
the Biomedical Advanced Research and Development Authority is an important first step,
and continued improvement in the response capacity at the state level is essential should
an outbreak occur. As multi-drug resistant diseases and new pandemic illnesses emerge,
lessons learned from treatment of these new threats may be applied to biodefense.
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67
APPENDIX 1
History of Federal Funding Distribution on Biodefense
Funding for biodefense and biosecurity has steadily increased since FY2001. Figures
A1.1-A1.6 show the estimated distributions among agencies.
Figure A1.1. FY2001 Funding for Biodefense by Federal Agency ($m)
Figure A1.2. FY2002 Funding for Biodefense by Federal Agency ($m)
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Figure A1.3. FY2003 Funding for Biodefense by Federal Agency ($m)
Figure A1.4. FY2004 Funding for Biodefense by Federal Agency ($m)
69
Figure A1.5. FY2005 Funding for Biodefense by Federal Agency ($m)
Figure A1.6. FY2006 Funding for Biodefense by Federal Agency ($m)
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APPENDIX 2
Glossary of Terms
AMC: Army Medical Corp
AMP: Accelerated Manufacture of Pharmaceuticals
APHIS: Animal and Plant Health Inspection Service
ARS: Agricultural Research Service
ATDC: Advanced Technology Development Center
ATP: Advanced Technology Programs
BAA: Broad Agency Announcement system
BARDA: Biomedical Advanced Research and Development Authority
BIO: The Biotechnology Industry Organization
BNBI: Battelle National Biodefense Institute
CDC: Centers for Disease Control and Prevention
CIC: Chesapeake Innovation Center
COCA: Clinical Outreach and Communication Activity
CRADAs: Cooperative Research and Development Agreements
CRP: Chemical Reagents Program
DARPA: Defense Advanced Research Projects Agency
DHHS: Department of Health & Human Services
DHS: Department of Homeland Security
DIB: Defense Industrial Base
DOC: Department of Commerce
DOD: Department of Defense
DOE: Department of Energy
DOJ: Department of Justice
DOT: Department of Transportation
DSO: Defense Sciences Office
DTRA: Defense Threat Reduction Agency
EPA: Environmental Protection Agency
EWIDS: Early Warning Infectious Disease Surveillance
FDA: Food and Drug Administration
FEMA: Federal Emergency Management Agency
FFRDCs: Federally Funded Research and Development Centers
GAO: Government Accountability Office
GPS: Global Positioning System
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HHS: Department of Health and Human Services
HSARPA: Homeland Security Advanced Research Projects Agency
IDIQ: Indefinite-Delivery Indefinite-Quantity
IMERT: Illinois Mobile Emergency Response Team
I-NEDSS: Illinois Electronic Disease Surveillance System
IPHMAS: Illinois Public Health Mutual Aid System
ITAC: Industry Trade Advisory Center
LHD: Local Health Department
MABAS: Mutual Aid Box Alarm System
MLA: McKenna, Long and Aldridge
NBACC: National Biodefense Analysis and Countermeasures Center
NBSB: National Biodefense Science Board
NEDSS: National Electronic Disease Surveillance System
NIAID: National Institute of Allergy and Infectious Diseases
NIH: National Institutes of Health
NIST: National Institute of Standards and Technology
NNSA: National Nuclear Security Administration
NSABB: National Science Advisory Board for Biosecurity
NSF: National Science Foundation
OHA: Office of Health Affairs
OIE: World Organization for Animal Health
OMB: Office of Management and Budget
PART: Program Assessment Rating Tool
PLA: Patent License Agreements
RCE: Regional Centers of Excellence
RVA: Rapid Vaccine Assessment
SARS: Severe Acute Respiratory Syndrome
SBIR: Small Business Innovation Research Program
SNDT: Chem/Bio Sensor Network Design Tool
State: Department of State
STO: Strategic Technology Office
STTR: Small Business Technology Transfer Program
TACTIC: Threat Agent Cloud Tactical Intercept and Countermeasure
TANS: Technology Acceleration for National Security
TRTF: Texas Research and Technology Foundation
TSWG: Technical Support Working Group
72
UASI: Urban Areas Security Initiative
UAV: Unmanned Aerial Vehicles
USAMRIID: U.S. Army Medical Research Institute of Infectious Disease
USDA: Department of Agriculture
USPS: U.S. Post Office
USTR: United States Trade Representative
VA: Veterans Administration
VIG: Vaccinia Immune Globulin
WHO: World Health Organization
WIC: Watervliet Innovation Center
WMD: Weapons of Mass Destruction
73