GAO-09-878R, Project BioShield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats


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GAO-09-878R: 

United States Government Accountability Office: 
Washington, DC 20548: 

July 24, 2009: 

Congressional Committees: 

Subject: Project BioShield Act: HHS Has Supported Development, 
Procurement, and Emergency Use of Medical Countermeasures to Address 
Health Threats: 

This report formally transmits the attached briefing in response to 
section 247d-6c of title 42 of the United States Code. (See the 
enclosure.) The statute required the Comptroller General to examine the 
Department of Health and Human Services' (HHS) support for the 
development and procurement of and authority for the emergency use of 
medical countermeasures to address chemical, biological, radiological, 
and nuclear threats to public health, and provide the results to the 
congressional committees by July 21, 2009.[Footnote 1] HHS determines 
priorities for medical countermeasure procurement based on those 
chemical, biological, radiological, and nuclear agents that have been 
identified by the Department of Homeland Security as posing a material 
threat to the U.S. population that could affect national security. We 
provided the briefing to staff of your committees to satisfy the 
mandate reporting requirement on July 20, 2009, and July 21, 2009. 

We are sending copies of this report to the Secretary of HHS, the 
Secretary of Homeland Security, and other interested parties. In 
addition, the report will be available at no charge on the GAO Web site 
at [hyperlink, http://www.gao.gov] . 

If you or your staff have any questions regarding this report, please 
contact me at (202) 512-7114 or bascettac@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this report. Key contributions to this report were 
made by Karen Doran, Assistant Director; George Bogart; Natalie Herzog; 
Amy C. Leone; Roseanne Price; and Rasanjali Wickrema. 

Singed by: 

Cynthia A. Bascetta: 
Director, Health Care: 

Enclosure: 

List of Congressional Committees: 

The Honorable Edward M. Kennedy: 
Chairman: 
The Honorable Michael B. Enzi: 
Ranking Member: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Joseph I. Lieberman: 
Chairman: 
The Honorable Susan M. Collins: 
Ranking Member: 
Committee on Homeland Security and Governmental Affairs: 
United States Senate: 

The Honorable Robert C. Byrd: 
Chairman: 
The Honorable George Voinovich: 
Ranking Member: 
Subcommittee on Homeland Security: 
Committee on Appropriations: 
United States Senate: 

The Honorable Tom Harkin: 
Chairman: 
The Honorable Thad Cochran: 
Ranking Member: 
Subcommittee on Labor, Health and Human Services, Education, and 
Related Agencies: 
Committee on Appropriations: 
United States Senate: 

The Honorable Henry A. Waxman: 
Chairman: 
The Honorable Joe Barton: 
Ranking Member: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Bennie G. Thompson: 
Chairman: 
The Honorable Peter T. King: 
Ranking Member: 
Committee on Homeland Security: 
House of Representatives: 

The Honorable Edolphus Towns: 
Chairman: 
The Honorable Darrell Issa: 
Ranking Member: 
Committee on Oversight and Government Reform: 
House of Representatives: 

The Honorable David E. Price: 
Chairman: 
The Honorable Harold Rogers: 
Ranking Member: 
Subcommittee on Homeland Security: 
Committee on Appropriations: 
House of Representatives: 

The Honorable David R. Obey: 
Chairman: 
The Honorable Todd Tiahrt: 
Ranking Member: 
Subcommittee on Labor, Health and Human Services, Education, and 
Related Agencies: 
Committee on Appropriations: 
House of Representatives: 

[End of section] 

Enclosure: 

Project BioShield Act: HHS Has Supported Development, Procurement, and 
Emergency Use of Medical Countermeasures to Address Health Threats: 

Briefing for the staffs of the: 

Committee on Health, Education, Labor, and Pensions: 
Committee on Homeland Security and Governmental Affairs: 
Subcommittee on Homeland Security, Committee on Appropriations: 
Subcommittee on Labor, Health and Human Services, Education, and 
Related Agencies, Committee on Appropriations: 
United States Senate. 

Committee on Energy and Commerce: 
Committee on Homeland Security: 
Committee on Oversight and Government Reform: 
Subcommittee on Homeland Security, Committee on Appropriations 
Subcommittee on Labor, Health and Human Services, Education, and 
Related Agencies, Committee on Appropriations: 
House of Representatives. 

July 20, 2009, and July 21, 2009. 

Overview: 

Introduction; 
Objectives; 
Scope and Methodology; 
Background; 
Results; 
Agency Comments. 

Introduction: 

The terrorist attacks of September 11, 2001, and the subsequent attacks 
using anthrax-laced letters have raised congressional concerns that the 
United States is vulnerable to threats from chemical, biological, 
radiological, and nuclear (CBRN) agents, including agents responsible 
for naturally emerging infectious diseases that could cause illness on 
a scale that adversely affects national security. 

Members of the Congress have noted the need for the United States to 
have medical countermeasures (MCM), such as vaccines, drugs, therapies, 
and diagnostic tools, to respond to CBRN agents and to adequately 
protect the public from such threats or provide after-exposure 
treatment. 

Members of the Congress and others have attributed the limited 
availability of CBRN countermeasures to a lack of economic incentives 
to invest the millions of dollars required to bring treatments to 
market for uncommon diseases and conditions, such as anthrax. 

To encourage the development of new CBRN medical countermeasures, the 
Project BioShield Act of 2004 (Pub.L.No.108-276), was enacted to, among 
other things, 

* facilitate the creation of a government market by authorizing the 
appropriation of about $5.6 billion from fiscal years 2004 through 2013 
to purchase MCMs, including those that may require additional 
development; 

* under specified conditions, allow the Secretary of the Department of 
Health and Human Services (HHS) to authorize the temporary emergency 
use (through emergency use authorizations, or EUAs) of (1) certain 
medical products that have not yet received Food and Drug 
Administration(FDA) approval or (2) unapproved use of an FDA-approved 
product; and; 

* provide HHS with authorities to facilitate CBRN MCM research-and 
development-related spending, including a streamlined authority for 
hiring experts. 

The Project BioShield Act directs the Department of Homeland Security 
(DHS) to conduct assessments of the threats posed by CBRN agents and to 
issue material threat determinations for CBRN agents that pose a threat 
to the U.S. population that could affect national security. 

Objectives: 

GAO is required to report on the implementation of the Project 
BioShield Act by provisions of the act. This briefing describes the 
status of: 

1. Medical countermeasures supported by the Project BioShield Act that 
are available or being developed to address identified and emerging 
threats to public health from CBRN agents determined by DHS. 

2. HHS’s use of its authority to allow the temporary emergency use of 
medical countermeasures, and whether it developed procedures governing 
such use. 

3. HHS’s use of its streamlined personnel authority under the Project 
BioShield Act. 

Scope and Methodology: 

We reviewed HHS and DHS information and documentation, including: 

* HHS’s annual reports to the Congress on the implementation of the 
Project BioShield Act; 

* HHS’s Public Health Emergency Medical Countermeasures Enterprise 
Strategy (referred to as the HHS Enterprise Strategy); 

* HHS’s Public Health Emergency Medical Countermeasures Enterprise 
Implementation Plan (referred to as the HHS Enterprise Implementation 
Plan), which guides MCM research, development, and procurement; 

* FDA guidance on authorizing the emergency use of MCMs; 

* DHS determinations of CBRN agents that pose threats to the U.S. 
population. 

We interviewed officials from: 

* HHS’s Office of the Assistant Secretary for Preparedness and 
Response(ASPR) and the Biomedical Advanced Research and Development 
Authority (BARDA); 

* Centers for Disease Control and Prevention (CDC); 

* National Institutes of Health (NIH); 

* FDA; 

* DHS. 

We also reviewed: 

* legislation, 
* presidential directives, 
* Federal Register notices and federal agency letters about EUAs, and; 
* documents from the Congressional Research Service. 

We conducted our work from April 2009 through July 2009 in accordance 
with all sections of GAO’s Quality Assurance Framework that are 
relevant to our objectives. The framework requires that we plan and 
perform the engagement to obtain sufficient and appropriate evidence to 
meet our stated objectives and to discuss any limitations in our work. 
We believe that the information and data obtained, and the analysis 
conducted, provide a reasonable basis for any findings and conclusions 
in this product. 

Background: Project BioShield Authorities and Funding: 

The Project BioShield Act of 2004 provides authorities and authorizes 
funding to accelerate the research, development, acquisition, and 
availability of effective MCMs. 

The Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA) 
(Pub.L.No. 109-417) clarified that the scope of the Project BioShield 
Act includes MCMs for biological agents that could cause naturally 
occurring infectious diseases that may cause a public health emergency 
affecting national security. PAHPA also established BARDA as a focal 
point within HHS for the advanced development and acquisition of MCMs. 

The Project BioShield Act authorized the appropriation of $5.593billion 
over 10 years (fiscal years 2004 through 2013) for the procurement of 
MCMs. The Department of Homeland Security Appropriations Act, 2004 
(Pub.L.No. 108-90 (2003)) appropriated $5.593 billion for this purpose. 

Background: Identified CBRN Agents: 

DHS has identified 13 CBRN agents that pose a material threat to 
national security. 

* HHS has incorporated these identified agents in its Enterprise 
Implementation Plan. (See table 1.) 

* HHS’s Enterprise Implementation Plan also includes volatile nerve 
agents, which had not received a DHS material threat determination as 
of July 2009. 

Table 1: 13 CBRN Agents Identified by DHS as Posing a Material Threat 
to National Security, as of July 2009: 

2004: 
Anthrax (Bacillus anthracis); 
Botulism (botulinumtoxins); 
Radiological/nuclear agents; 
Smallpox (variolavirus). 

2006: 
Glanders (Burkholderiamallei); 
Ebola virus (hemorrhagic fever); 
Junin virus (hemorrhagic fever); 
Marburg virus (hemorrhagic fever); 
Melioidosis (Burkholderia pseudomallei); 
Multi-drug-resistant anthrax (MDR Bacillus anthracis); 
Plague (Yersiniapestis); 
Tularemia (Franciscella tularensis); 
Typhus (Rickettsia prowazekii). 

Sources: DHS, HHS Enterprise Implementation Plan, and the HHS Project 
BioShield Annual Report to Congress, August 2006-July 2007. 

[End of table] 

Background: HHS’s Role in MCMs: 

Through the Project BioShield Act, PAHPA, and national planning 
documents, HHS is charged with providing leadership in research, 
development, acquisition, deployment, and guidance for use of MCMs 
through its various components, including: 

* BARDA (within ASPR), which is responsible for providing a 
coordinated, systematic approach to the development and acquisition of 
MCMs; 

* CDC, which maintains MCMs in the Strategic National Stockpile (SNS; 
the federal supply of pharmaceuticals, vaccines, and so forth, for 
critical medical care of high-priority diseases and conditions) and 
acquires some FDA-approved MCMs for the SNS; 

* FDA, which approves pharmaceuticals, licenses biologicals such as 
vaccines, and clears or approves medical devices that could be used as 
MCMs; and; 

* NIH, which has been authorized to expedite and simplify the 
solicitation, review, and award of grants and contracts for the 
development of MCMs. 

Background: HHS’s Role in EUAs: 

The Project BioShield Act also authorizes the HHS Secretary to allow 
the temporary use of certain medical products, such as drugs, vaccines, 
or medical devices, as MCMs. 

These products include: 

* unapproved products (i.e., products not yet approved or cleared by 
FDA) and; 

* unapproved uses of approved products (i.e., unapproved uses of 
approved drugs and cleared or approved devices). 

These products could be used in a declared emergency to diagnose, 
treat, or prevent serious or life-threatening diseases or conditions 
caused by CBRN agents when there are no adequate, approved, and 
available alternatives. 

In using this authority, the HHS Secretary would first declare an 
emergency justifying the temporary use of a product based on a 
determination of an actual or significant potential for one of three 
types of emergency involving specific CBRNs: 

* a domestic emergency determined by the DHS Secretary involving a 
heightened risk of attack, 

* a military emergency determined by the Secretary of Defense involving 
a heightened risk of attack to U.S. military forces, or, 

* a public health emergency determined by the HHS Secretary that 
affects or could affect national security. 

The Secretary has delegated to the FDA Commissioner the responsibility 
for issuing EUAs after the declaration of an emergency. 

The FDA Commissioner may issue an EUA when certain criteria are met. 
For example, 

* the agent specified in the emergency declaration can cause a serious 
or life-threatening disease and, 

* the known and potential benefits outweigh the known and potential 
risks of the product to diagnose, prevent, or treat the condition. 

Background: Streamlined Personnel Authority: 

The Project BioShield Act provides streamlined personnel authority for 
the hiring of professional and technical employees at NIH to perform, 
administer, or support research and development for MCMs. 

This authority allows for: 

* streamlined hiring of up to 30 individuals at NIH at any one time, 

* a flexible pay scale for those employees, and, 

* preference for specific individuals when hiring those employees. 

Results: 

1. Under the Project BioShield Act, HHS has supported development and 
procurement of seven MCMs to address four CBRN agents that are 
identified as threats to public health and has plans for additional 
MCMs that address both identified and emerging threats. 

2. Using its delegated authority from the Secretary of HHS, FDA has 
issued seven EUAs for medical products to address existing threats of 
exposure to the novel influenza A (H1N1) virus and potential threats 
from the intentional use of anthrax. Additionally, FDA has developed 
guidance for issuance of the EUAs. 

3. HHS has used its streamlined personnel authority to hire seven staff 
at NIH as of July 2009. 

1: HHS Has Supported Development of MCMs for Some Threats and Has Plans 
to Address Others: Seven MCMs for Four CBRN Agents Identified as 
Threats: 

Seven MCMs are available or being developed under existing procurement 
contracts to address four CBRN agents that are identified as threats to 
public health. (See table 2.) 

The seven MCMs address the first four public health threats identified 
by DHS in 2004 (anthrax, botulism, radiological/nuclear, and smallpox). 

Two of the four threats have more than one MCM because the MCMs are for 
different uses or have unique characteristics. 

In addition, HHS has announced two requests for proposals to develop 
additional MCMs for: 

* a “next generation” anthrax vaccine using the latest technology and, 

* a smallpox antiviral drug for individuals who may be symptomatic with 
smallpox disease and for whom the current vaccine would be ineffective. 

Status of MCMs for CBRN Agents Identified as Threats: 

Table 2: Status of MCMs Supported by the Project BioShield Act for 
Identified Threats from CBRN Agents: 

CBRN agent: Anthrax; 
MCM: AVA anthrax vaccine; 
MCM use: FDA licensed for prevention before exposure. Prevention after 
exposure in combination with antibiotics; 
MCM unique characteristics: This is the only currently licensed anthrax 
vaccine; 
Status of MCM: Available, FDA licensed for prevention before exposure. 

CBRN agent: Anthrax; 
MCM: Raxibacumab; 
MCM use: Treatment of anthrax disease; 
MCM unique characteristics: An antibody therapy directed against the 
anthrax toxin to treat symptomatic individuals; 
Status of MCM: Under development. 

CBRN agent: Anthrax; 
MCM: Anthrax immune globulin; 
MCM use: Treatment of anthrax disease; 
MCM unique characteristics: A plasma-derived therapy against the 
anthrax toxin to treat symptomatic individuals; 
Status of MCM: Under development. 

CBRN agent: Botulism; 
Heptavalent botulism antitoxin; 
Treatment of botulinum poisoning; 
Antitoxin is the only available treatment for any of the seven 
botulinumtoxins; 
Status of MCM: Under development. 

CBRN agent: Radiological/nuclear; 
MCM: Potassium iodide; 
MCM use: Treatment after exposure to radioactive iodine; 
MCM unique characteristics: This product would be used for children to 
protect the thyroid gland from damage due to radioactive iodine; 
Status of MCM: Available. 

CBRN agent: Radiological/nuclear; 
MCM: Intravenous pentetate calcium trisodium and pentetate zinc 
trisodium; 
MCM use: Treatment after exposure to certain forms of radioactive 
matter (transuranic elements); 
MCM unique characteristics: This product would be used to bind specific 
ingested or inhaled forms of radioactive matter and remove them from 
the body; 
Status of MCM: Available. 

CBRN agent: Smallpox; 
MCM: Modified vaccinia ankara smallpox vaccine; 
MCM use: Prevention before exposure to smallpox; 
MCM unique characteristics: This vaccine is being developed as a 
potentially safer vaccine for certain populations (i.e., immune-
compromised persons); 
Status of MCM: Under development. 

Source: HHS. 

[End of table] 

Plans for MCMs for Identified Threats: 

The HHS Enterprise Implementation Plan covers proposed development and 
procurement through 2013 for MCMs for identified threats. (See table 
3.) 

* Through future Project BioShield Act contracts, HHS proposes to help 
develop and procure additional MCMs to address all of the 13 identified 
threats. 

* An additional class of agents identified in the HHS Enterprise 
Implementation Plan, volatile nerve agents, is not addressed through 
Project BioShield Act contracts; instead, HHS is pursuing development 
and acquisition of these MCMs for volatile nerve agents using other 
funding. 

Planned MCMs for CBRN Agents Identified as Threats: 

Table 3: Planned MCM Development and Procurement through Fiscal Year 
2013 for Identified Threats: 

CBRN agent: Anthrax(Bacillus anthracis); 
Planned MCMs: Broad spectrum antibiotics (effective against a wide 
range of bacteria), diagnostic tools, antitoxin. 

CBRN agent: Botulism (botulinum toxins); 
Planned MCMs: Diagnostic tools. 

CBRN agent: Glanders (Burkholderia mallei); 
Planned MCMs: Broad spectrum antibiotics, diagnostic tools. 

CBRN agent: Ebola virus (hemorrhagic fever); 
Planned MCMs: Antiviral and/or a vaccine, diagnostic tools. 

CBRN agent: Junin virus (hemorrhagic fever); 
Planned MCMs: Diagnostic tools. 

CBRN agent: Marburg virus (hemorrhagic fever); 
Planned MCMs: Antiviral and/or a vaccine, diagnostic tools. 

CBRN agent: Melioidosis (Burkholderia pseudomallei); 
Planned MCMs: Broad spectrum antibiotics, diagnostic tools. 

CBRN agent: Multi-drug-resistant anthrax (MDR Bacillus anthracis); 
Planned MCMs: Broad spectrum antibiotics, diagnostic tools, antitoxin. 

CBRN agent: Plague (Yersiniapestis); 
Planned MCMs: Broad spectrum antibiotics, diagnostic tools. 

CBRN agent: Radiological/nuclear agents; 
Planned MCMs: Bioassay to determine the strength of these agents, 
biodosimetry to assess the likelihood of developing acute radiation 
syndrome, and others. 

CBRN agent: Smallpox (variolavirus); 
Planned MCMs: Diagnostic tools, antivirals. 

CBRN agent: Tularemia (Franciscella tularensis); 
Planned MCMs: Broad spectrum antibiotics, diagnostic tools. 

CBRN agent: Typhus (Rickettsia prowazekii); 
Planned MCMs: Broad spectrum antibiotics, diagnostic tools. 

CBRN agent: Volatile nerve agents; 
Planned MCMs: Not addressed by Project BioShield Act funding. 

Source: HHS Enterprise Implementation Plan. 

[End of table] 

Plans for MCMs for Emerging Threats: 

The HHS Enterprise Strategy and the HHS Enterprise Implementation Plan 
include guidelines and principles for addressing emerging threats, 
which are defined as naturally occurring organisms that are newly 
recognized or anticipated to present a public health threat, such as 
severe acute respiratory syndrome (SARS). 

In addition to plans for developing MCMs specific to individual agents, 
the HHS Enterprise Strategy and the HHS Enterprise Implementation Plan 
contain plans for countermeasures with broader applications to address 
emerging threats, including the following: 

* Developing flexible MCMs to address more than one threat, such as 
broad-spectrum antibiotics to address multiple bacterial agents. 

* Developing “platform technologies” that provide the capability to 
rapidly develop and produce MCMs to address emerging threats. 

2: FDA Has Issued Seven EUAs as of July 2009 and Established Procedures 
for Their Use: 

Using its delegated authority from the HHS Secretary, FDA has issued 
seven EUAs for medical products to address existing threats of exposure 
to the novel influenza A (H1N1) virus and potential threats from the 
intentional use of anthrax: 

* five EUAs for a public health emergency, 

* one EUA for a military emergency, and, 

* one EUA for a domestic emergency. 

Five EUAs for a Public Health Emergency: 

As of July 2009, FDA has issued five EUAs for MCMs used to identify, 
prevent, and treat novel influenza A (H1N1) virus: 

* MCMs: Drugs: Relenza and Tamiflu (two EUAs), diagnostic kits (two 
EUAs), and respirators (one EUA) to identify, prevent, and treat novel 
influenza A (H1N1) virus. 

* Population affected: General public. 

* Authorized use: The EUA allows the MCMs to be administered for 
unapproved uses; for example, Tamiflu is allowed to be given to infants 
under 1 year old, which is younger than previously approved. 

* Effective dates:The EUAs are effective for 1 year with the issuance 
dates ranging from April 27, 2009, through May 2, 2009, unless 
terminated or revoked. 

One EUA for a Military Emergency: 

As of July 2009, FDA has issued one EUA for an MCM used for prevention 
of inhalation anthrax for a military emergency: 

* MCM: Anthrax vaccine adsorbed (AVA) for prevention of inhalation 
anthrax. 

* Population affected: Military individuals deemed by the Department of 
Defense to be at a heightened risk of exposure from an anthrax attack. 

* Authorized use: The EUA allowed use of the MCM to prevent inhalation 
anthrax until the resolution of legal actions that deemed it an 
unapproved use. 

* Effective dates: This EUA was initially effective for 6 months, 
beginning January 27, 2005. The EUA was extended for an additional 6 
months, effective July 22, 2005. 

One EUA for a Domestic Emergency: 

As of July 2009, FDA has issued one EUA for an MCM for prevention of 
inhalation anthrax in response to a determination of a significant 
potential for a domestic emergency: 

* MCM: Doxycyclinehyclate tablets in emergency kits for prevention of 
inhalation anthrax. 

* Population affected: U.S. Postal Service mail carriers eligible to 
deliver antibiotics to homes in selected cities during an emergency, as 
part of the Cities Readiness Initiative Program, and their families. 

* Authorized use: The EUA allows the unapproved use of the MCM because 
the kits include information that was not part of the approved drug 
application. 

* Effective dates: The EUA is effective for 1 year from October 1,2008, 
unless terminated or revoked. 

FDA Has Established Procedures for EUAs: 

FDA established procedures for EUAs in its Guidance: Emergency Use 
Authorization of Medical Products, which was published in July 2007.[A] 

The guidance discusses issues such as: 

* Declaration of emergency; 
* Eligibility for an EUA; 
* Request for consideration for an EUA; 
* Processing of an EUA; 
* Conditions of authorization for an EUA; 
* Revocation or termination of an EUA; 
* Preemption issues when states have existing requirements governing 
dispensing, administration, or labeling of unapproved medical products 
or approved medical products for unapproved uses; 
* Liability protection and compensation under other statutes. 

[A] The guidance was first published in draft form in 2005. 

3: HHS Has Used the Streamlined Personnel Authority to Hire Seven Staff 
at NIH: 

HHS has used its streamlined personnel authority to hire seven staff at 
NIH as of July 2009. 

* HHS officials said NIH has used this authority to fill key positions 
related to product development, including: 

- Associate Director for Biodefense Product Development and; 
- Associate Director for Radiation Countermeasures Research and 
Emergency Preparedness. 

* HHS officials said this authority was helpful because it allowed, 
among other things, the hiring of staff at NIH at competitive salaries. 

* HHS officials noted that the ability to use this streamlined 
personnel authority could be critical if a future large-scale emergent 
threat or terrorist action were to occur. This authority would allow 
NIH to rapidly identify and appoint experts to assist in responding to 
the event. 

Agency Comments: 

To obtain agency comments, we provided a draft of these briefing slides 
to HHS and DHS and discussed the draft with officials from the two 
agencies. The agencies provided e-mail and oral comments. 

The agencies generally agreed with the information presented in the 
draft and also provided technical comments, which we incorporated as 
appropriate. 

In commenting on the draft, HHS noted that Project BioShield is an 
“unprecedented national effort” to procure MCMs against the most 
pressing CBRN threats to public health and said that the effort has 
experienced significant success during its first 5 years of 
implementation. HHS also noted that the Project BioShield Act allows 
HHS not only to procure available MCMs but also to support development 
of MCMs through the agency’s ability to award contracts to acquire MCMs 
as much as 8 years before the MCMs receive FDA approval. HHS also noted 
that it does not expect to be able to support the development and 
procurement of MCMs for all 13 of the CBRN agents that have received 
material threat determinations before 2013, the final year for which 
appropriations are authorized under the Project BioShield Act, because 
of both scientific and financial reasons. 

[End of enclosure] 

Footnotes: 

[1] The Project BioShield Act of 2004 also required the Comptroller 
General to review other issues, such as how HHS has used its Project 
BioShield Act contracting and purchasing authorities to enhance its 
ability to procure medical countermeasures, and the extent to which HHS 
has sufficient internal controls in place to manage and ensure the 
appropriate use of its Project BioShield Act contracting and purchasing 
authorities. We address these issues in a separate report, Project 
Bioshield: HHS Can Improve Agency Internal Controls for Its New 
Contracting Authorities, [hyperlink, 
http://www.gao.gov/products/GAO-09-820] (Washington, D.C.: July 21, 
2009). 

[End of section] 

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