GAO-12-304R Thermal Burn Countermeasures

United States Government Accountability Office

Washington, DC 20548

February 22, 2012

The Honorable Joseph I. Lieberman

Chairman

The Honorable Susan M. Collins

Ranking Member

Committee on Homeland Security and Governmental Affairs

United States Senate

Subject: National Preparedness: Countermeasures for Thermal Burns

A failed car bomb attempt in New York City in spring 2010 underscored the nation’s 

vulnerability to intentional terrorist threats from explosive devices, such as 

conventional explosives, radiological “dirty bombs,” and nuclear weapons.1 The blast 

and subsequent fires from such weapons could inflict serious thermal burns; in the 

case of a nuclear detonation, these injuries could affect hundreds to thousands of 

people.2 In such an attack, stabilizing individuals with burns and other injuries would 

be an immediate priority. Medical care for thermal burns in a mass casualty incident 

would require the ready availability of large quantities of medical countermeasures, 

such as pain medications, wound dressings, and intravenous fluids, both on-site and 

in emergency treatment facilities.

The Department of Health and Human Services (HHS)3 is the federal agency 

primarily responsible for identifying and supporting the development and acquisition 

of the medical countermeasures needed to prevent or mitigate potential health 

effects from exposure to chemical, biological, radiological, and nuclear (CBRN) 

agents and other terrorist threats.4

 

1

A dirty bomb, or radiological dispersal device, is a mix of explosives, such as dynamite, with 

radioactive material. When the dynamite or other explosives are set off, the blast carries radioactive 

material into the surrounding area.

In addition to identifying these countermeasures, 

including those for thermal burns, HHS also has responsibility for engaging with 

industry to research and develop them and, ultimately, for acquiring them for the 

2

Thermal burns, as distinguished from chemical and electrical burns or injury to the skin from 

radioactive isotopes, are caused by intense light and heat.

3

For a full list of abbreviations, see enc. I. 

4

For a list of previous GAO products relevant to this topic, see Related GAO Products at the end of 

this report.
 2 GAO-12-304R Thermal Burn Countermeasures

U.S. Strategic National Stockpile (SNS), if appropriate.5 The Project BioShield Act of 

2004 authorized the establishment of a procurement fund for these 

countermeasures. Specifically, the act authorized the appropriation of about 

$5.6 billion over the 10-year period from fiscal year 2004 through fiscal year 2013 for 

the Project BioShield Special Reserve Fund to acquire certain medical 

countermeasures for the SNS.6

Multiple organizations have raised concerns about HHS’s ability to work with 

industry to successfully develop and acquire medical countermeasures to respond to 

CBRN incidents and other terrorist threats, and since 2004 congressional 

committees have held several hearings to assess HHS’s medical countermeasure 

development and acquisition efforts.7 You requested that we examine whether HHS 

has developed and acquired medical countermeasures that address thermal burn 

injuries that would result from conventional explosives or radiological or nuclear 

devices. Our review addresses (1) the medical countermeasures in the SNS that 

would address thermal burns, (2) the steps HHS has taken to obtain information 

about and inform industry of its interest in additional countermeasures for thermal 

burns, and (3) the medical countermeasures in the pipeline for development and 

acquisition into the SNS that could serve to address thermal burns.

To identify the medical countermeasures in the SNS that would address thermal 

burns, we reviewed relevant HHS documents, such as risk assessments, 

requirements papers, documentation of the contents of the SNS and related gap 

analyses, and other HHS information about the types of medical countermeasures 

needed and the department’s prioritization of countermeasures for thermal burns. 

We interviewed HHS officials from the Office of the Assistant Secretary for 

Preparedness and Response (ASPR), the Biomedical Advanced Research and 

Development Authority (BARDA), the Centers for Disease Control and Prevention 

(CDC), the Food and Drug Administration (FDA), and the National Institutes of 

Health (NIH) to obtain information on the types and status of medical 

countermeasures in the SNS that are available to treat thermal burns. We also 

interviewed burn experts, such as officials from the American Burn Association and 

the Department of Defense, to gain a better understanding of thermal burns and the 

care and treatment of these injuries. Finally, we interviewed state and local 

 

5

The SNS is a national repository of medications, medical supplies, and equipment for use in a public 

health emergency. SNS items may be stored in dedicated warehouses, preplaced in local or state 

jurisdictions, or managed by pharmaceutical and medical device manufacturers if needed for use in a 

public health emergency. In addition, HHS may have agreements in place with hospitals or other 

facilities to make use of certain products in the event of a public health emergency.

6

The Project BioShield Act of 2004 authorized the appropriation of funds for the Special Reserve 

Fund for the acquisition of certain medical countermeasures using the authorities granted under that 

law. 6 U.S.C. § 321j. Prior to enactment of this law, the Department of Homeland Security

appropriations act for fiscal year 2004 appropriated the amount of the Special Reserve Fund. Pub. L. 

No. 108-90, 117 Stat. 1137, 1148 (2003).

7

For example, see Senate Committee on Appropriations, Subcommittee on Labor, Health and Human 

Services, Education, and Related Agencies, Defending Against Public Health Threats, 111th Cong., 

2nd sess., 2010; Senate Committee on Homeland Security and Governmental Affairs, Six Years after 

Anthrax: Are We Better Prepared to Respond to Bioterrorism? 110th Cong., 1st sess., 2007; and 

House Committee on Homeland Security, Subcommittee on Emerging Threats, Cybersecurity, and 

Science and Technology, Can BioShield Effectively Procure Medical Countermeasures That 

Safeguard the Nation? 110th Cong., 1st sess., 2007.
 3 GAO-12-304R Thermal Burn Countermeasures

government disaster management officials to obtain a better understanding of the 

issues related to deployment of thermal burn countermeasures.

To identify the steps HHS has taken to obtain information about and inform industry 

of its interest in additional countermeasures for thermal burns, we reviewed HHS’s 

medical and public health consequence assessments and countermeasure 

requirements, and documentation and reviews of the contents of the SNS. We also 

reviewed HHS’s requests for information, notices, and any other information HHS 

made publicly available from 2010 through 2011 to determine how HHS 

communicated its thermal burn countermeasure needs to industry and other 

partners. We chose this period because it reflects HHS’s most recent activities for 

countermeasure development and acquisition. We interviewed HHS officials to 

obtain information on how the department determined the need for thermal burn 

countermeasures and the extent to which HHS has provided information to industry 

about its thermal burn countermeasure needs. We also contacted experts

knowledgeable about HHS’s medical countermeasure activities, including officials at 

the Institute of Medicine and officials from five pharmaceutical and medical device 

companies varying in size and product mix that have experience working with HHS 

on countermeasure development or acquisition, to obtain their perspectives on the 

extent to which HHS has provided information to industry and other relevant 

stakeholders about its thermal burn countermeasure needs.

To identify the medical countermeasures in the pipeline for development and 

acquisition into the SNS that could serve to address thermal burns, we reviewed 

BARDA and NIH data on medical countermeasure investments for CBRN and 

related incidents. This review helped us to determine which investments could serve 

to address needs for thermal burn countermeasures and to analyze NIH data on 

countermeasures currently in the pipeline that could address thermal burns. We 

interviewed HHS officials to obtain information on how they identify candidate 

products in the pipeline that have the potential for use as countermeasures for 

thermal burns.

We conducted this performance audit from October 2011 to January 2012 in 

accordance with generally accepted government auditing standards. Those 

standards require that we plan and perform the audit to obtain sufficient, appropriate 

evidence to provide a reasonable basis for our findings and conclusions based on 

our audit objectives. We believe that the evidence obtained provides a reasonable 

basis for our findings and conclusions based on our audit objectives.

Results in Brief

The SNS contains supportive care items for thermal burns, such as bandages, pain 

medications, intravenous fluids, and topical antimicrobial cream needed for the 

immediate treatment of burn injuries to reduce the risk of infection and stabilize 

injured individuals. HHS officials told us that the goal of the SNS is to supplement 

state and local supplies used for immediate care in the initial response—identified as 

within 72 hours of sustaining injury. CDC compiled supplies needed for the 

immediate treatment of burn injuries into kits in 2002 and 2003, based on 

information provided at that time by burn experts about needed items. Because most 
 4 GAO-12-304R Thermal Burn Countermeasures

medical countermeasures for thermal burns can be found in local hospitals, 

countermeasures in the SNS would be used to supplement local supplies and 

inventories, with kits deployed within 24 to 48 hours of notification. The SNS does 

not contain other countermeasures that may be available for both the immediate 

care and the longer-term treatment of burn injuries. However, HHS is currently 

considering whether to acquire some additional countermeasures, including those 

for longer-term treatment of burn injuries.

HHS has taken several steps since 2010 to obtain information about thermal burn 

countermeasures, such as conducting interviews and site visits with burn experts, 

clinicians, and industry officials, which also signaled to industry HHS’s interest in 

these products. HHS has issued two formal notices to solicit information from 

industry about the types of countermeasures that may be available specifically to 

treat thermal burns in a mass casualty incident. For example, these notices solicit 

information about products for immediate care of thermal burns, such as bandages

with antimicrobial barriers that could be used for several days without needing to be 

changed, and products for longer-term burn care, such as temporary skin 

substitutes. HHS officials stated that in response to these notices and consistent 

with the Federal Acquisition Regulation (FAR), HHS has also had e-mail, telephone, 

and in-person discussions with interested companies. In addition, HHS has 

discussed with industry the department’s interest in these additional 

countermeasures at regional meetings held in 2011.

NIH has some medical countermeasures that are currently in the development and 

acquisition pipeline that could serve to address thermal burns. The National Institute 

of Allergy and Infectious Diseases (NIAID), the NIH institute tasked with developing 

a research program to identify and develop new medical countermeasures for use in 

radiological and nuclear incidents, is funding research on candidate 

countermeasures, such as topical creams and antibiotics. NIAID is also funding 

basic research on the effects of burns and radiation injuries to skin and other tissue. 

NIH’s National Institute of General Medical Sciences is currently funding research on 

potential or improved burn care treatment. According to HHS officials, NIH’s National 

Institute of Arthritis and Musculoskeletal and Skin Diseases is also funding research 

on such treatment.

Background

Care of Thermal Burns Following a Mass Casualty Incident

Thermal burns from fires, conventional explosives, or radiological and nuclear 

weapons are treated similarly in the first days and weeks of injury.8

 

8

For burns sustained from radiological or nuclear detonations, once initial burn care has begun, 

affected individuals would be monitored for radiation exposure and short- and long-term health effects 

of such exposure in the weeks and months after an incident.

Immediate 

treatment of thermal burns may require medical countermeasures such as 

intravenous pain medications and fluids, wound dressings, and intubation if an 

airway is obstructed by swelling resulting from the burns. In addition, individuals with 

thermal burns sustained in a mass casualty incident may require topical 
 5 GAO-12-304R Thermal Burn Countermeasures

antimicrobial cream or antimicrobial barrier bandages and dressings to prevent or 

mitigate infection and stabilize patients. Antimicrobial barrier bandages and 

dressings may include those that are impregnated with silver as the antimicrobial 

agent and do not need frequent changing for patients who may not be able to be 

cared for immediately or may need to be transferred to specialized burn centers.

Longer-term treatment for serious burns may require surgical removal of damaged 

skin and grafting of temporary skin or skin substitutes until permanent skin grafting 

using the patient’s own skin can be performed. Typical products used for temporary 

coverage include cadaver or pig skin. For prolonged periods of time beyond the 

acute or initial phase of the medical response, care for serious thermal burns also 

requires additional specialized staff, resources, and equipment. These additional 

needs make the overall response to a mass casualty incident complicated. For 

example, the number of health care providers with significant burn care expertise 

may be in short supply locally, and care for severely burned individuals beyond the 

initial response requires complex, expensive, resource-intensive care, such as skin 

grafts. There are approximately 1,850 burn beds in 126 burn units across the United 

States. The American Burn Association estimates that 700 to 800 of these beds may 

be occupied at any given time. To respond to a mass casualty incident such as a 

nuclear detonation—in which HHS estimates the number of individuals requiring 

specialized burn care could be over 10,000—burn patients would need to be 

transferred to specialized burn centers throughout the country because there may be 

relatively few dedicated burn beds available in the region. In addition, patients may 

need to be treated in other care sites, such as trauma centers, if specialized burn 

centers are filled to capacity.

Federal Roles and Responsibilities Related to Medical Countermeasures

In 2006, HHS established the Public Health Emergency Medical Countermeasures 

Enterprise (PHEMCE), a federal interagency body responsible for providing 

recommendations to the Secretary of HHS on medical countermeasure priorities, 

development and acquisition activities, and strategies for distributing and using 

medical countermeasures held in the SNS.9 PHEMCE’s working groups and senior 

council serve as the primary means of communication between HHS and 

participating federal departments on medical countermeasure issues. As required by 

the Pandemic and All-Hazards Preparedness Act of 2006, PHEMCE also conducts 

annual reviews of the contents of the SNS.10

Within HHS, several agencies and offices have specific responsibilities for medical 

countermeasure development and acquisition.

 

9

PHEMCE is composed of officials from several HHS offices and agencies that have specific 

responsibilities for countermeasure development and acquisition. PHEMCE also includes officials 

from other federal departments and offices, including officials from the Departments of Agriculture, 

Defense, Homeland Security, and Veterans Affairs. See GAO, National Preparedness: Improvements 

Needed for Acquiring Medical Countermeasures to Threats from Terrorism and Other Sources, 

GAO-12-121 (Washington, D.C.: Oct. 26, 2011).

10PHEMCE conducts these reviews on behalf of the HHS Secretary. 42 U.S.C. § 247d-6b(a)(1).
 6 GAO-12-304R Thermal Burn Countermeasures

• ASPR leads PHEMCE and the medical and public health response to potential 

mass casualty incidents, including strategic planning, medical countermeasure 

prioritization, and support for developing and acquiring medical 

countermeasures.

• Within ASPR, BARDA—established by the Pandemic and All-Hazards 

Preparedness Act—oversees advanced development and acquisition of some 

medical countermeasures into the SNS.11

• NIH’s NIAID leads the agency’s CBRN countermeasure programs and, as such, 

conducts and funds basic and applied research needed to develop new or 

enhanced medical countermeasures and related medical tools to protect the 

nation against threats posed by CBRN agents.

• CDC maintains the SNS and supports state and local public health departments’ 

efforts to detect and respond to public health emergencies, including providing 

guidance and recommendations for the mass distribution and use of medical 

countermeasures from the SNS.

• FDA assesses the safety and effectiveness of medical countermeasures and 

regulates their development, approval or licensure, and postmarket surveillance 

as part of its overall role to assess the safety and effectiveness of medical 

products.12 FDA also provides technical support for the creation of tools to 

support medical countermeasure development and may authorize the emergency 

use of medical products that have not yet been approved or licensed or were 

approved or licensed only for other uses.

Medical Countermeasure Research, Development, Acquisition, and Support

HHS’s and PHEMCE’s medical countermeasure acquisition strategy is based on a 

multistep process that includes assessing the threat and public health consequences 

of CBRN agents, determining the type and quantity of needed medical 

countermeasures, evaluating the public health response capability, and developing 

and acquiring countermeasures for the SNS. The Project BioShield Act requires 

HHS to assess the public health consequences of exposure to CBRN agents that 

the Department of Homeland Security (DHS) determines are material threats to the 

nation13

 

1142 U.S.C. § 247d-7e(c). The act also gave BARDA the authority to make advance and milestonebased payments to vendors prior to product delivery to the SNS. 42 U.S.C. § 247d-7e(c)(5)(C), (D).

and to determine for which of these agents medical countermeasures are 

12Under federal law and FDA regulations, vaccines and other biologics are “licensed,” drugs are 

“approved,” and devices may either be “approved” or “cleared.” See 42 U.S.C. § 262, 21 U.S.C. 

§ 355, 21 U.S.C. §§ 360e, 360(k).

13As part of its responsibilities under the Project BioShield Act, DHS develops material threat 

assessments to assess the threat posed by given CBRN agents or classes of agents and the 

potential number of human exposures in plausible, high-consequence scenarios. DHS uses the 

material threat assessments to determine which CBRN agents pose a material threat sufficient to 

affect national security. See GAO, National Preparedness: DHS and HHS Can Further Strengthen 

Coordination for Chemical, Biological, Radiological, and Nuclear Risk Assessments, GAO-11-606

(Washington, D.C.: June 21, 2011).
 7 GAO-12-304R Thermal Burn Countermeasures

necessary to protect the public’s health.14 HHS’s public health consequence 

modeling reports use the exposure information from DHS’s material threat 

assessments to calculate the number of individuals who may become ill, be 

hospitalized, or die based on a specific scenario or set of scenarios. HHS then 

evaluates the public health response capability based in part on the availability of 

desired medical countermeasures. Because desired medical countermeasures may 

not be developed to a point where they are available for acquisition, NIH and 

BARDA oversee and support countermeasure research and development, which is 

conducted in several stages: (1) basic research, (2) applied research, (3) early 

development,15 and (4) advanced development.16 (See fig. 1.) NIH and NIAID 

typically provide federal funding for basic and applied research and early 

development. BARDA typically funds advanced development of medical 

countermeasures. If a medical countermeasure is not FDA approved or licensed,17

its acquisition into the SNS is typically funded by the Project BioShield Special 

Reserve Fund.18 If a countermeasure is FDA approved or licensed, CDC may 

purchase the countermeasure for the SNS.

 

1442 U.S.C. § 247d-6b(c)(2)(B).

15This early, or basic, research seeks to better understand the effects of illness and injury sustained 

from CBRN incidents and the response of the host organism to illness and injury through the study of 

the cellular and molecular biology and physiologic processes. Applied, or translational, research 

builds on basic research by validating and testing concepts in practical settings to identify potential 

products. Successful concepts move from the applied research stage into the early development 

stage, in order to demonstrate basic safety, reproducibility, and ability to be used in humans.

16In the advanced development stage, potential medical countermeasures are further evaluated to 

demonstrate safety and effectiveness for preventing, diagnosing, or treating disease. Successful 

products are then available for development and acquisition. In addition, BARDA determines whether 

manufacturing, scale-up production, and licensing of countermeasures can be achieved in a timely 

and reliable manner.

17In addition to approving or licensing medical countermeasures, FDA works with researchers 

throughout the development stages to review safety and effectiveness test results and provide 

technical assistance to help ensure that research meets FDA’s regulatory requirements.

18The Project BioShield Act provides that the Special Reserve Fund may be used to acquire 

countermeasures for which the HHS Secretary determines the scientific research supports a 

reasonable conclusion that the product will qualify for FDA approval or licensing within 8 years.

42 U.S.C. § 247d-6b(c)(1)(B)(i)(III)(bb).
 8 GAO-12-304R Thermal Burn Countermeasures

Figure 1: Processes for Medical Countermeasure Development and Acquisition

a

In addition to approving or licensing medical countermeasures, FDA works with researchers throughout the development 

stages to review safety and effectiveness test results and provide technical assistance to help ensure that research meets 

FDA’s regulatory requirements.

The SNS Contains Supportive Care Items for the Immediate Treatment of 

Thermal Burns, Such as Bandages and Pain Medications

The thermal burn countermeasures in the SNS include supportive care items for 

thermal burns compiled in kits that include sterile bandages and dressings, pain 

medications, intravenous fluids, and topical antimicrobial cream needed for the 

immediate treatment of burn injuries to reduce the risk of infection and stabilize 

injured individuals. According to HHS officials, the goal of the SNS is to supplement 

state and local supplies used for immediate care in the initial response—within 

72 hours of sustaining injury. In addition to the items needed specifically for burns, 

CDC officials told us that the SNS contains certain multiuse products that could be 

helpful for treating patients with thermal burns. For example, the SNS contains 

airway management supplies such as ventilators and intubation supplies, as well as 

ancillary supplies for this equipment, which would be needed for individuals with 

compromised airways.19

 

19According to CDC officials, the thermal burn countermeasures are for treating heat-related injuries 

regardless of heat source and may be of some use in treating radiation or chemical injuries. Airway 

management and ancillary supplies may also be used in treating the health effects of exposure to 

other CBRN agents and infectious diseases, such as pandemic influenza, and in treating injuries 

other than burns.

Most of the thermal burn countermeasures in the SNS were 

initially acquired in 2002 and 2003. HHS officials told us that CDC acquired the 

supplies for the burn kits after consulting with burn clinicians about needed products. 

For example, officials from burn centers as well as the American Burn Association 

provided CDC with a list of recommended products for the immediate treatment of 

burns, which included topical antimicrobial creams and other supplies to prevent 

infection and stabilize individuals. CDC officials told us that most medical 

countermeasures for immediate treatment of thermal burns can typically be found in 

local hospitals and community medical care sites. Therefore, in an incident requiring 

thermal burn care, countermeasures in the SNS could be used to supplement local 

supplies and inventories. According to CDC officials, the thermal burn 

countermeasure kits can be deployed to an affected area within 24 to 48 hours of 

notification.
 9 GAO-12-304R Thermal Burn Countermeasures

The SNS does not contain other countermeasures that may be available for thermal 

burns, but HHS is currently considering whether to acquire additional 

countermeasures for immediate and longer-term burn care. In September 2010, 

HHS established the PHEMCE Thermal Burns Product Coordination Team, which is 

specifically responsible for assessing available medical countermeasures for the 

treatment of thermal burns that might be sustained during a nuclear detonation. 

According to HHS officials, this coordination team has discussed the possibility of 

acquiring additional products and supplies for both the immediate care and the 

longer-term treatment of burn injuries. As part of this process, in October 2011, HHS 

completed an analysis of the number and types of thermal burns that would 

potentially be sustained in a nuclear detonation and the resources and capabilities 

needed to care for injured individuals. HHS officials told us that this analysis 

provided HHS and PHEMCE with an estimate of the demand for thermal burn 

products and helped identify what may currently be available in the market to close 

any gaps in available supplies. The analysis also included HHS’s requirements for 

needed types and quantities of additional thermal burn countermeasures. Although 

HHS has not yet made any decisions about whether to add specific products to the 

SNS, burn clinicians and burn experts told us that countermeasures that ideally 

should be in the SNS for immediate care of burns within the 72-hour window after 

injury include supplies such as silver-impregnated antimicrobial barrier bandages 

and dressings, topical antimicrobial creams, intravenous fluids, and pain 

medications. Some burn clinicians and experts indicated that silver-impregnated 

antimicrobial barrier bandages and dressings, which are not currently in the SNS, 

could be useful for stabilizing patients until they could be transported to a burn 

center, where specialized personnel could care for them. Clinicians and experts told 

us that these products, which are available from several different manufacturers, 

may be beneficial since the dressings may not need to be changed for several days, 

can be stored at room temperature, and require less specialized skill to apply than 

topical antimicrobial creams. This could be helpful in a mass casualty incident in 

which immediate access to burn clinicians may be limited. Local and state 

government disaster management officials agreed that countermeasures needed in 

the SNS for the immediate care of thermal burn injuries would include topical 

antimicrobial creams, silver-impregnated antimicrobial barrier dressings, and other 

supplies that would allow first responders to conduct burn first aid and stabilize 

patients until they could be treated in a burn center.

The SNS also does not contain, and HHS is not currently stockpiling, 

countermeasures for longer-term care, such as artificial skin and other skin 

therapies. Burn clinicians and experts we spoke with were uncertain about the 

benefit of stockpiling products for longer-term care in the SNS for several reasons. 

First, burn clinicians and experts emphasized that even if there were existing 

stockpiles of skin products and available burn beds, the availability of clinicians with 

the appropriate expertise to administer these therapies would be the limiting factor, 

because artificial skin or skin substitutes require application by skilled burn 

surgeons. Second, burn clinicians and CDC officials told us that biological products 

such as artificial skin have very short shelf lives. For example, some artificial skin 

products have a shelf life of 18 to 24 months. CDC officials pointed out that if HHS 

stockpiles more of these products than are used in the United States on a routine 

basis, HHS may need to dispose of expired and unused excess quantities. Third, 
 10 GAO-12-304R Thermal Burn Countermeasures

burn clinicians and experts also told us that products for longer-term care, such as 

artificial skin and skin therapy products, must be kept refrigerated at very low 

temperatures. This storage need may also complicate the transport of these 

products to care sites.

HHS Met with Experts and Industry Representatives and Issued Notices of 

Interest to Solicit Information about Thermal Burn Countermeasures

HHS has taken several steps to obtain information about thermal burn 

countermeasures, which also signaled to industry its interest in these products. To 

obtain information about existing and needed countermeasures for thermal burns, 

HHS and the PHEMCE thermal burns coordination team that was established in 

September 2010 conducted outreach to potential end users of these products, 

including physicians, burn experts, and first responders. For example, HHS officials 

conducted interviews with representatives from the American Burn Association, 

clinicians at local and regional burn centers, and Department of Defense burn 

researchers and experts. HHS and PHEMCE participants visited burn centers and 

attended meetings with burn experts. HHS also conducted interviews with industry 

representatives to obtain information about potential products in development.

HHS has issued several notices to solicit information from industry about thermal 

burn countermeasures,20

• In December 2010, BARDA issued a request for information (RFI) for thermal 

burn countermeasures to solicit information from manufacturers about the types 

of products that may be in development or available to treat thermal burns 

resulting from a mass casualty nuclear detonation.

which also informed industry about HHS’s interest in 

additional thermal burn countermeasures.

21 The RFI also sought 

information on the degree to which potential products would require specialized 

expertise or specialized resources, the capability of manufacturers to “surge” 

production—or increase their usual rates of production and supply—and 

alternate strategies for stockpiling potential products.

• In August 2011, BARDA issued a “sources sought” notice for information on 

thermal burn countermeasures for a mass casualty nuclear detonation incident.22

 

20In addition to the notices specifically for thermal burn countermeasures, in March 2011, HHS also 

renewed its 2009 Broad Agency Announcement soliciting advanced research and development for 

the range of medical countermeasures for CBRN agents that PHEMCE is interested in acquiring. 

According to HHS, proposals for the development of thermal burn countermeasures are within the 

scope of the Broad Agency Announcement. 

The sources sought notice expanded on the previous RFI to solicit additional 

21An RFI may be issued when an agency requires technical, scientific, or business information, or a 

combination of these, and input from the marketplace for project planning purposes regarding the 

availability of existing or potential solutions. The notice and the information received are not to be 

used to determine how well respondents can perform a requirement, which can only be evaluated in 

response to a solicitation. 48 C.F.R. § 315.201.

22The primary purpose of a sources sought notice is to identify all potential sources, regardless of 

organizational type and size classification, and determine their capabilities to fulfill a potential 

government requirement. Like an RFI, the notice and the information received are not to be used to 

determine how well respondents can perform a requirement, which can only be evaluated in response 

to a solicitation. 48 C.F.R. § 305.205.
 11 GAO-12-304R Thermal Burn Countermeasures

detail about products that could be used by first responders in the field for 

immediate care and for products that could be used by clinicians in medical 

settings for longer-term burn care. Desired products for immediate care include 

bandages with antimicrobial barriers that could be used for several days without 

needing to be changed and other bandages or dressings that would require 

minimal changing. Desired products for longer-term care include temporary skin 

substitutes and products that use an individual’s own skin cells to form skin 

substitutes or replacements. HHS officials told us that because the department 

did not limit the notices to either immediate or long-term care products, it 

received information on a mix of products, some of which reflect advances in 

products since the burn kits in the SNS were assembled. For example, the SNS 

contains silver-based antimicrobial cream that must be applied to burns, covered 

with a bandage, and reapplied at least once every 24 hours; newer products 

include bandages impregnated with antimicrobial silver that only require applying 

the bandage and can be changed less frequently.

HHS officials told us that consistent with the FAR, HHS has also discussed its 

interest in thermal burn countermeasures through e-mail, telephone, and in-person 

discussions with industry representatives and at the department’s regional medical 

countermeasure meetings. HHS officials told us that once the department posted the 

thermal burns RFI, HHS held a number of technology meetings and had telephone 

and e-mail conversations with industry representatives. In addition, in January, June, 

and October 2011, BARDA held regional “industry days” for countermeasure 

manufacturers during which HHS officials discussed the department’s interest in 

thermal burn countermeasures. According to HHS officials, the technology meetings 

and regional meetings allowed HHS to obtain additional information from industry 

about potential thermal burn countermeasures in development.

Some Medical Countermeasures in Development Could Address Thermal 

Burns

NIH has some medical countermeasures in the development and acquisition pipeline 

that could address thermal burns. NIAID, the institute at NIH that coordinates CBRN 

countermeasure research and development for injuries caused by radiation 

exposure combined with other injuries such as thermal burns, informed us that the 

countermeasures for thermal burns in the pipeline include topical creams and 

antibiotics, such as a topical formula using amino acid peptides. In addition, NIAID is 

funding basic research to determine how burns and radiation-related injuries affect 

skin and other tissue on a molecular level.23

Within NIAID, medical countermeasures that could address thermal burns are a 

secondary focus of most of its research, according to officials. NIAID’s research 

primarily concentrates on radiation injury combined with burns and other injuries. In 

addition, NIAID officials told us that the research on these combined radiation and 

thermal burn injuries and potential countermeasure candidates is still in the early 

 

23According to NIH officials, as part of its CBRN countermeasure work, NIAID routinely works with 

NIH’s National Cancer Institute to determine whether its countermeasure research may be applicable 

to radiation-induced injuries.
 12 GAO-12-304R Thermal Burn Countermeasures

stages. Therefore, NIAID officials did not provide us with an estimate of how long it 

could take HHS to acquire any of these candidate countermeasures, if successful, 

for the SNS.24

In addition to the research being funded by NIAID, other NIH institutes are also 

funding burn research. For example, NIH’s National Institute of General Medical 

Sciences funds academic research centers and training programs in trauma, burn, 

and wound healing. This institute is currently funding research on potential burn care 

treatments, which may be helpful in developing future countermeasures for thermal 

burns. For example, one research study is examining the effects of certain white 

blood cells in burn healing, burn excision, and skin grafting for the purposes of 

potentially developing therapeutics for burn patients. According to HHS officials, 

NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases is also 

funding research on such treatment.

Agency Comments

We provided a draft of this report to HHS, and its comments are reprinted in 

enclosure II. In its comments, HHS stated that the report provides a fair and 

balanced presentation of HHS’s efforts to prepare for a mass casualty incident that 

could result in a large number of individuals with thermal burns. HHS discussed its 

thermal burn countermeasure development and acquisition activities, including 

stockpiling supportive care products for the immediate treatment of thermal burns 

and exploring the development of new and improved products for longer-term burn 

care. HHS also described other BARDA and PHEMCE activities beyond 

countermeasure development and acquisition that could help the department 

respond to a mass casualty incident, such as the National Disaster Medical 

System’s detailed roster of available personnel who could support state and local 

authorities’ medical response efforts. In addition, HHS provided technical comments, 

which we incorporated as appropriate.

– – – – – 

We are sending copies of this report to the Secretary of HHS and interested 

congressional committees. In addition, the report is available at no charge on the 

GAO website at http://www.gao.gov. 

 

24The federal government faces a variety of challenges in developing and acquiring medical 

countermeasures. One scientific challenge is that as with other medical products, the failure rate for 

development of certain CBRN medical countermeasures can be higher than 80 percent for those 

drugs, vaccines, and diagnostic devices in the early development stage, with an increasing probability 

of success as the product moves further through development. In addition, HHS estimates that the 

period from scientific discovery to product licensure or approval of successful countermeasures can 

be as long as 20 years. See GAO, Public Health Preparedness: Developing and Acquiring Medical 

Countermeasures Against Chemical, Biological, Radiological, and Nuclear Agents, GAO-11-567T

(Washington, D.C.: Apr. 13, 2011).
 13 GAO-12-304R Thermal Burn Countermeasures

If you or your staff members have any questions about this report, please contact 

me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page of this 

report. GAO staff who made key contributions to this report are listed in enclosure III.

Marcia Crosse

Director, Health Care

Enclosures – 3 
Enclosure I 

14 GAO-12-304R Thermal Burn Countermeasures

Abbreviations

ASPR Office of the Assistant Secretary for Preparedness and Response

BARDA Biomedical Advanced Research and Development Authority

CBRN chemical, biological, radiological, and nuclear

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

FAR Federal Acquisition Regulation

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIAID National Institute of Allergy and Infectious Diseases

NIH National Institutes of Health

PHEMCE Public Health Emergency Medical Countermeasures Enterprise

RFI request for information

SNS Strategic National Stockpile
Enclosure II 

15 GAO-12-304R Thermal Burn Countermeasures

Comments from the Department of Health and Human Services
Enclosure II

 16 GAO-12-304R Thermal Burn Countermeasures
Enclosure II

 17 GAO-12-304R Thermal Burn Countermeasures
Enclosure III

18 GAO-12-304R Thermal Burn Countermeasures

GAO Contact and Staff Acknowledgments

GAO Contact

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

Staff Acknowledgments

In addition to the contact named above, key contributors to this report were: 

Sheila K. Avruch, Assistant Director; Shana R. Deitch; Tracey King; Carolina M. 

Morgan; Roseanne Price; and Jessica C. Smith.
19 GAO-12-304R Thermal Burn Countermeasures

Related GAO Products 

Chemical, Biological, Radiological, and Nuclear Risk Assessments: DHS Should 

Establish More Specific Guidance for Their Use. GAO-12-272. Washington, D.C.: 

January 25, 2012.

National Preparedness: Improvements Needed for Acquiring Medical 

Countermeasures to Threats from Terrorism and Other Sources. GAO-12-121. 

Washington, D.C.: October 26, 2011.

National Preparedness: DHS and HHS Can Further Strengthen Coordination for 

Chemical, Biological, Radiological, and Nuclear Risk Assessments. GAO-11-606. 

Washington, D.C.: June 21, 2011.

Public Health Preparedness: Developing and Acquiring Medical Countermeasures 

Against Chemical, Biological, Radiological, and Nuclear Agents. GAO-11-567T. 

Washington, D.C.: April 13, 2011.

Measuring Disaster Preparedness: FEMA Has Made Limited Progress in Assessing 

National Capabilities. GAO-11-260T. Washington, D.C.: March 17, 2011.

National Security: Key Challenges and Solutions to Strengthen Interagency 

Collaboration. GAO-10-822T. Washington, D.C.: June 9, 2010.

Combating Nuclear Terrorism: Actions Needed to Better Prepare to Recover from 

Possible Attacks Using Radiological or Nuclear Materials. GAO-10-204. Washington, 

D.C.: January 29, 2010.

Emergency Preparedness: State Efforts to Plan for Medical Surge Could Benefit 

from Shared Guidance for Allocating Scarce Medical Resources. GAO-10-381T. 

Washington, D.C.: January 25, 2010.

Homeland Defense: Planning, Resourcing, and Training Issues Challenge DOD’s 

Response to Domestic Chemical, Biological, Radiological, Nuclear, and High-Yield 

Explosive Incidents. GAO-10-123. Washington, D.C.: October 7, 2009.

Interagency Collaboration: Key Issues for Congressional Oversight of National 

Security Strategies, Organizations, Workforce, and Information Sharing. 

GAO-09-904SP. Washington, D.C.: September 25, 2009.

Project BioShield Act: HHS Has Supported Development, Procurement, and 

Emergency Use of Medical Countermeasures to Address Health Threats. 

GAO-09-878R. Washington, D.C.: July 24, 2009.

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