[Federal Register Volume 72, Number 53 (Tuesday, March 20, 2007)]
[Notices]
[Pages 13109-13114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5066]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of the Assistant Secretary for Preparedness and Response; 
HHS Public Health Emergency Medical Countermeasures Enterprise Strategy 
for Chemical, Biological, Radiological and Nuclear Threats

AGENCY: Office of the Assistant Secretary for Preparedness and 
Response, Department of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The United States faces serious public health threats from the 
deliberate use of weapons of mass destruction (WMD)--chemical, 
biological, radiological, or nuclear (CBRN)--by hostile States or 
terrorists, and from naturally emerging infectious diseases that have a 
potential to cause illness on a scale that could adversely impact 
national security. Effective strategies to prevent, mitigate, and treat 
the consequences of CBRN threats is an integral component of our 
national security strategy. To that end, the United States must be able 
to rapidly develop, stockpile, and deploy effective medical 
countermeasures to protect the American people. This HHS Public Health 
Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE 
Strategy) establishes the goals and objectives that HHS will employ to 
ensure that medical countermeasures are available for effective use 
against the highest priority CBRN threats facing the Nation. The HHS 
PHEMCE Strategy considers the full spectrum of medical countermeasures-
related activities, including research, development, acquisition, 
storage/maintenance, deployment, and utilization. The HHS PHEMCE 
Strategy is consistent with the President's Biodefense for the 21st 
Century and aligned with the National Strategy for Medical 
Countermeasures against Weapons of Mass Destruction.

DATES: This notice is effective as of March 14, 2007.

FOR FURTHER INFORMATION CONTACT: Dr. Susan Coller, Policy Analyst, 
Office of Public Health Emergency Medical Countermeasures, Office of 
the Assistant Secretary for Preparedness and Response at 330 
Independence Ave., SW., Room G640, Washington, DC 20201 or by phone: 
202-260-1200.

Introduction

    The United States faces serious public health threats from the 
deliberate use of chemical, biological, radiological, or nuclear (CBRN) 
weapons of mass destruction (WMD) by hostile states or terrorists, and 
from naturally emerging infectious diseases that have the potential to 
cause illness on a scale that could adversely impact national security. 
The type and magnitude of both CBRN and naturally-occurring threats are 
evolving. Chemical exposures can result from accidents as well as 
deliberate releases. Advances in biotechnology support the development 
of new medical treatments, but also make those same tools more widely 
available to adversaries who might use them to modify biological 
organisms with the intention to inflict harm. New diseases, like Severe 
Acute Respiratory Syndrome (SARS), emerge; and regionally endemic 
diseases, like West Nile Fever and Rift Valley Fever, are introduced 
into susceptible populations. Nuclear technologies may proliferate 
despite international efforts to contain them.
    A failure to anticipate these threats or the lack of a capacity to 
effectively prevent them could leave an untold number of Americans dead 
or permanently disabled. The United States must be able to effectively 
develop, stockpile, and rapidly deploy critical medical countermeasures 
to prevent, mitigate, and treat the adverse health consequences of 
threats both natural and manmade. Given the diverse and dynamic nature 
of these threats, and the expense and time required to develop threat 
agent-specific medical countermeasures, a strategy must be developed 
that prioritizes investment and optimizes the ability to protect the 
Nation.

The Role of the Department of Health and Human Services in Public 
Health Preparedness

    Within the Federal government, the Department of Health and Human 
Services (HHS) leads the research, development, acquisition, 
deployment, and use of effective medical countermeasures to protect the 
civilian population from WMD. This key role was identified in the 
National Strategy to Combat Weapons of Mass Destruction,\1\ Biodefense 
for the 21st Century,\2\ and the National Strategy for Medical 
Countermeasures against Weapons of Mass Destruction,\3\ which together 
are the President's blueprint for addressing the Nation's CBRN defense 
programs.
---------------------------------------------------------------------------

    \1\ http://www.whitehouse.gov/news /releases/2002/12/
WMDStrategy.pdf.
    \2\ http://www.whitehouse.gov/homeland/20040430.html.
    \3\ http://www.whitehouse.gov/news/ releases/2007/02/20070207-
2.html.
---------------------------------------------------------------------------

    Within HHS, multiple operating and staff divisions work together to 
develop and implement strategies to prevent and control disease, 
injury, illness, and disability from terrorist threats and naturally-
occurring diseases capable of negatively impacting Government and 
social systems. In July 2006, HHS created the Public Health Emergency 
Medical Countermeasures Enterprise (PHEMCE).\4\ The PHEMCE is a 
coordinated, intra-agency effort led by the Office of the Assistant 
Secretary for Preparedness and Response \5\ (ASPR) and includes three 
HHS internal agencies: the Centers for Disease Control and Prevention 
(CDC), the Food and Drug Administration (FDA), and the National 
Institutes of Health (NIH). The mission of the PHEMCE is to: (1) Define 
and prioritize requirements for public health emergency medical 
countermeasures; (2) integrate and coordinate research, early and late 
stage product development, and procurement activities addressing the 
requirements; and (3) set deployment and use

[[Page 13110]]

strategies for medical countermeasures held in the Strategic National 
Stockpile (SNS).
---------------------------------------------------------------------------

    \4\ Federal Register, Vol. 71, No. 129, Thursday, July 6, 2006, 
Notices.
    \5\ Formerly the Office of Public Health Emergency Preparedness; 
changed to reflect the Pandemic and All-Hazards Preparedness Act 
enacted on December 19, 2006 (P.L. 109-417).
---------------------------------------------------------------------------

    Many resources throughout HHS have already been coordinated in 
support of medical countermeasure preparedness. Funding support by the 
NIH for basic research, product development, and clinical research of 
CBRN medical countermeasures has grown from $53 million in Fiscal Year 
2001 (FY01) to $1.8 billion in FY06. Funding for the SNS similarly has 
grown from $52 million in FY01 to $530 million in FY06. Furthermore, on 
July 21, 2004, President George W. Bush signed into law the Project 
BioShield Act of 2004 (Project BioShield).\6\ The purpose of Project 
BioShield is to accelerate the research, development, acquisition, and 
availability--including through use of the Emergency Use Authorization 
(EUA)--of safe and effective medical countermeasures to protect the 
United States from CBRN threats. Project BioShield created a $5.6 
billion special reserve fund for use over 10 years (FY04--FY13) to 
acquire these medical countermeasures.
---------------------------------------------------------------------------

    \6\ http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_ cong--public--laws&docid=f:publ090.108.pdf.
---------------------------------------------------------------------------

    During its first two years of implementation, Project BioShield 
acquisitions were guided by requirements derived from interagency 
deliberations in 2003 that involved Cabinet-level Departments and the 
Executive Office of the President. Under this initial strategy, HHS 
pursued acquisitions for those highest priority threats for which there 
were candidate products at relatively advanced stages of development. 
These products included medical countermeasures for anthrax, smallpox, 
botulinum toxins, and radiological/nuclear agents \7\--the four threat 
agents initially determined by the Department of Homeland Security 
(DHS) to pose a material threat to national security.\8\ The relatively 
advanced nature of the products pursued resulted from years of earlier 
investment made in large part by NIH and the Department of Defense 
(DOD).
---------------------------------------------------------------------------

    \7\ To date, contracts have been awarded using the Project 
BioShield special reserve fund for the purchase of anthrax 
therapeutics, anthrax vaccines, botulism antitoxin, a pediatric 
formulation of potassium iodide (a drug that blocks absorption of 
radioactive iodide in the thyroid gland), and Calcium- and Zinc-DTPA 
(two forms of a decorporation agent to remove transuranic 
radionuclides from the body). The SNS also contains enough smallpox 
vaccine to protect every American, antibiotics for anthrax, adult 
(tablet) formulations of potassium iodide, the decorporation agent 
Prussian Blue, and additional supplies for treating the burn and 
blast injuries that could be associated with a nuclear event.
    \8\ The Project BioShield Act of 2004 requires the Secretary of 
Homeland Security, in consultation with the Secretary of Health and 
Human Services and the heads of other agencies, as appropriate, to 
determine which current and emerging CBRN threats present a material 
threat against the United States population sufficient to affect 
national security.
---------------------------------------------------------------------------

    In addition to the achievements made to date, more can and must be 
done. The National Strategy for Medical Countermeasures against Weapons 
of Mass Destruction provides guiding principles to align United States 
Government (USG) programs and funding mechanisms that support the 
research, development, acquisition, deployment, and utilization of 
medical countermeasures for current and future CBRN threats. In 
accordance with the National Strategy, HHS will continue its commitment 
to shape and execute a focused medical countermeasures program to 
protect the Nation's citizens against high priority CBRN threats where 
medical countermeasures can have the greatest impact. The NIH will 
continue its existing research and development efforts to identify 
medical countermeasures for known as well as emerging diseases. HHS 
will use the Biomedical Advanced Research and Development Authority 
(BARDA) in the Pandemic and All-Hazards Preparedness Act (Pub. L. 109-
417) to provide direct investment in medical countermeasure advanced 
research and development. Finally, HHS will use the Project BioShield 
special reserve fund and the Strategic National Stockpile resources to 
acquire, store, maintain and deploy top priority medical 
countermeasures.

Medical Countermeasure Preparedness For CBRN Threats: A Two-Stage 
Approach

    To fulfill the mission of the ASPR to lead the Nation in 
preventing, preparing for, and responding to the adverse health effects 
of public health emergencies and disasters, HHS through the PHEMCE is 
undertaking a two-stage approach to planning that aims to solicit 
stakeholder input and to efficiently integrate the requirements for, 
and the advanced development and acquisition of, medical 
countermeasures for priority CBRN threat agents.

Stage One

    The first stage is development of this Public Health Emergency 
Medical Countermeasures Enterprise Strategy 9 10 (HHS PHEMCE 
Strategy). The HHS PHEMCE Strategy establishes the goals and objectives 
that HHS will employ to ensure that the most appropriate medical 
countermeasures are developed and acquired for use against the highest 
priority CBRN threats facing the Nation. This HHS PHEMCE Strategy 
considers the full spectrum of medical countermeasures-related 
activities, including research, development, acquisition, storage/
maintenance, deployment, and utilization.
---------------------------------------------------------------------------

    \9\ A draft of this HHS PHEMCE Strategy was published in the 
Federal Register on September 8, 2006, for public comment and was 
presented and discussed at the 2006 BioShield Stakeholders Workshop 
on September 25-26, 2006. The HHS PHEMCE Strategy reflects input 
received from the stakeholders representing industry, academia, 
other non-governmental organizations, and State, local, and Federal 
governments. Additional information on the Workshop is available at 
www.hhs.gov/aspr/ophemc/bioshield/workshop.html.
    \10\ This HHS PHEMCE Strategy excludes pandemic influenza, which 
is addressed in the HHS Pandemic Influenza Plan, a blueprint for 
pandemic influenza preparation and response that provides guidance 
to Federal, State, and local policy makers and health departments. 
The HHS Pandemic Influenza Plan includes an overview of the threat 
of pandemic influenza, a description of the relationship of the HHS 
Pandemic Influenza Plan to other Federal plans, and an outline of 
key roles and responsibilities during a pandemic. It is aligned with 
the National Strategy for Pandemic Influenza, issued by President 
George W. Bush on November 1, 2005, and the Implementation Plan for 
the National Strategy for Pandemic Influenza, which guides the 
Nation's preparedness and response to an influenza pandemic.[0] 
Additional information is available at www.pandemicflu.gov.
---------------------------------------------------------------------------

Stage Two

    The second stage in this process is the development of the HHS 
PHEMCE Implementation Plan. This document, to be published in early 
2007, will outline the medical countermeasure programs that reflect 
threat priorities, threat agent characteristics, medical/public health 
consequence assessments, and the likelihood that effective medical and 
public health intervention will prevent and mitigate adverse health 
consequences. The HHS PHEMCE Implementation Plan will incorporate 
valuable lessons learned from the initial implementation of Project 
BioShield; consider new authorities made available in the Pandemic and 
All-Hazards Preparedness Act; and outline HHS near-, mid- and long-term 
goals for research, development, and acquisition of medical 
countermeasures, consistent with the goals defined in this HHS PHEMCE 
Strategy. The HHS Implementation Plan will be reviewed at least 
biennially and revised to reflect changes in the threat scope and the 
availability of new or improved countermeasures.
    While ASPR leads the execution of the HHS PHEMCE Implementation 
Plan, HHS recognizes that developing, acquiring, and utilizing medical 
countermeasures to prepare for and respond to CBRN events will require 
significant resources and unprecedented

[[Page 13111]]

cooperation among many stakeholders, including Federal counterparts 
outside HHS,\11\ private industry (domestic and international), State 
and local governments, frontline first responders and healthcare 
workers, academia, and the public.
---------------------------------------------------------------------------

    \11\ Partners include Department of Defense (DOD), Department of 
Homeland Security (DHS), Department of Labor (DOL), Department of 
Transportation (DOT), Department of State (DOS), Department of 
Veterans Affairs (DVA), Department of Energy (DOE), and Department 
of Agriculture (USDA).
---------------------------------------------------------------------------

Four Strategic Goals

    To address the challenges presented by the diverse CBRN threat 
spectrum, to mitigate the financial and programmatic risks associated 
with medical countermeasure development and acquisition, and to ensure 
that the development and acquisition of medical countermeasures 
significantly enhances the Nation's response and recovery capabilities, 
the following four strategic goals and underlying objectives will guide 
critical funding allocation decisions.

Goal 1. Identify and Prioritize Programs for the Development and 
Acquisition of Medical Countermeasures

    While a primary goal of HHS is to prepare the Nation to prevent and 
respond to the health effects of natural and manmade disasters, 
constraints of both time and financial resources do not allow for the 
development and acquisition of medical countermeasures to prevent and 
mitigate all threats, in all places, at all times, and for all people. 
Consequently, several factors must be considered when developing the 
most appropriate strategies for high priority CBRN threats. The 
prioritization of medical countermeasure development and acquisition 
programs that will be delineated in the HHS PHEMCE Implementation Plan 
will be informed by the following three objectives.
Objective 1. Establish the Relative Hierarchy of the Chemical, 
Biological, Radiological, and Nuclear Threat Classes
    In the process of determining the most effective ways to mitigate 
and treat the effects of the CBRN threats, it is essential to 
understand that the three threat classes (i.e., chemical, biological, 
and radiological/nuclear) are distinct in their feasibility of use and 
in their potential public health consequences. HHS recognizes that the 
overall strategy for protection against these threats must be broad 
enough to effectively mitigate the public health impact of a major 
chemical, biological, radiological, or nuclear event, while focusing 
preparations on developing and acquiring medical countermeasures to 
protect against the threat agents that have the greatest potential to 
cause catastrophic public health consequences and for which medical 
intervention will be effective, feasible, and pragmatic. Threat 
identification and prioritization to inform medical countermeasure 
development and acquisition is a collaborative effort between HHS and 
DHS. DHS has the lead in considering the best available intelligence 
and scientific information to identify and prioritize CBRN threats. DHS 
uses this as the basis for issuing determinations about which agents 
present a material threat sufficient to affect national security. DHS 
then provides HHS with estimates of the numbers of potentially exposed 
individuals using plausible, high-consequence scenarios for each 
threat. To inform subsequent medical and public health consequence 
assessments, HHS combines this data with medical consequence modeling, 
subject matter expert evaluations, domestic and international 
intelligence information, and information on current State and local 
response capabilities. The HHS PHEMCE Implementation Plan will consider 
all of these inputs when establishing the HHS medical countermeasure 
priorities and requirements.
Objective 2. Prioritize Gaps in the Research, Development, and 
Acquisition of Medical Countermeasures
    HHS is committed to investing in research and development of 
medical countermeasures that will provide the most benefit for 
preventing or treating the effects of exposure to CBRN threats. HHS 
will apply the following specific guidelines and principles when 
evaluating potential investments.
    Medical \12\ versus Non-Medical \13\ Countermeasures. HHS will 
address the relative value of medical countermeasures and non-medical 
countermeasures, both within each class of threat agent and across all 
classes of threat agents. The HHS PHEMCE Implementation Plan will be 
developed with the overall goal of creating--through investments in 
research, development, and acquisitions--a portfolio that optimizes 
public health preparedness using the best combined strategies to 
prevent, mitigate, and treat the effects of a catastrophic CBRN event.
---------------------------------------------------------------------------

    \12\ Includes both pharmaceutical medical countermeasures (e.g., 
vaccines, antibiotics, antitoxins) and non-pharmaceutical medical 
countermeasures (e.g., ventilators, devices, personal protective 
equipment such as face masks and gloves).
    \13\ Includes elements such as contact and transmission 
interventions, social distancing, and community shielding.
---------------------------------------------------------------------------

    Prevention and Mitigation versus Treatment. HHS will address both 
medical prevention and medical treatment alternatives for public health 
preparedness. Given cost/benefit and implementation considerations, 
post-event diagnostics, prophylaxis, and/or treatment are likely to be 
the preferred strategies for most threats; however, pre-event medical 
countermeasures (such as vaccines) may still be appropriate for some 
high priority threats.
    Acute versus Chronic. Many CBRN agents have the potential to cause 
acute health consequences. In addition to relieving these acute 
consequences, early mitigation and treatment may prevent subsequent 
chronic health effects. The HHS PHEMCE Implementation Plan, therefore, 
will give priority to addressing the acute (immediate to weeks 
timeframe) medical and/or public health outcomes resulting from CBRN 
threat agents, while acknowledging that some threats, despite early 
interventions, may cause long-term health consequences.
    Specific versus Broad-spectrum. The USG must be capable of 
responding to a wide variety of potential challenges, including 
traditional as well as novel biological agents that are highly 
communicable, associated with a high rate of morbidity or mortality, 
and potentially without known countermeasure at the time of discovery. 
Identified in the National Strategy for Medical Countermeasures against 
Weapons of Mass Destruction is the spectrum of potential biological 
threat agents that pose such risks. These include threats that are 
traditional (i.e., naturally occurring microorganisms or toxin products 
with the potential to be disseminated to cause mass casualties, such as 
anthrax and plague); enhanced (i.e., a traditional agent that has been 
modified or selected to circumvent current countermeasures, such as an 
engineered, antibiotic-resistant, bacterial pathogen[0]); emerging 
(i.e., a[0] naturally occurring organism that is newly recognized or 
anticipated to present a public health threat, such as Severe Acute 
Respiratory Syndrome-associated coronavirus [SARS-CoV][0][0]); or 
advanced (i.e., a novel organism that has been engineered or newly 
generated in the laboratory and that could be targeted to bypass 
traditional countermeasures or produce a more severe or otherwise 
enhanced spectrum of disease).
    Medical countermeasure acquisitions planned in the near-term will 
continue

[[Page 13112]]

to focus on addressing specific, high-priority threats with specific 
medical countermeasures. Where available, HHS will pursue development 
and acquisition of medical countermeasures that address multiple 
threats, as is the case with the current stockpile of antibiotics that 
are effective against multiple bacterial threat agents. A key challenge 
for the HHS PHEMCE Implementation Plan, however, will be to define the 
optimal balance between fixed and flexible defenses \14\ to best 
prepare for the future.
---------------------------------------------------------------------------

    \14\ Relman DA. Bioterrorism--Preparing to Fight the Next War, 
NEJM, 2006, 354(2):113-115. In the context of defense against 
biological threats, a fixed defense is a medical countermeasure 
intended for use against a specific organism and not useful in 
scenarios that employ a different organism.
---------------------------------------------------------------------------

    Fixed defenses (the so-called ``one bug--one drug'' approach) for 
medical counter-measure development can be time-consuming and 
expensive. To date, however, this has been the preeminent path for 
addressing current threats. This approach has been successful in part 
because it presents industry with clearly defined targets for product 
development. At the same time, however, the uncertainties associated 
with the CBRN threat environment require that the HHS PHEMCE 
Implementation Plan support the development of flexible defenses to 
allow for innovations in medical countermeasure design that may result 
in enhanced products. For example, the benefit of broad-spectrum 
pharmaceuticals and platform technologies \15\ will extend beyond their 
ability to counter current biological threat agents and will allow for 
rapid response to future threats. In addition, development of broad-
spectrum medical countermeasures and platform technologies may also 
contribute to the mitigation and treatment of the health effects 
associated with chemical and radiological/nuclear threats. Therefore, 
HHS will support the development of flexible medical countermeasures 
including broad-spectrum pharmaceuticals and diagnostics, while 
recognizing that, at least for the immediate future, some threats will 
require agent-specific medical countermeasures.
---------------------------------------------------------------------------

    \15\ Platform technologies are methods for developing and 
producing medical countermeasures that are rapidly adaptable to 
multiple threats.
---------------------------------------------------------------------------

    The NIH will continue its existing research and development efforts 
to identify medical countermeasures for known as well as emerging 
diseases. HHS will use the Biomedical Advanced Research and Development 
Authority (BARDA) in the Pandemic and All-Hazards Preparedness Act to 
provide direct investment in medical countermeasure advanced research 
and development. Finally, HHS will use the Project BioShield special 
reserve fund and the Strategic National Stockpile resources to acquire, 
store, maintain, and deploy top priority medical countermeasures. HHS 
will work to ensure that its internal agencies, including ASPR, NIH, 
FDA, and CDC, continue to present industry with clear and comprehensive 
guidelines for HHS expectations regarding the development, approval, 
and utilization policies for fixed and flexible defenses.
    General versus Special Populations. The HHS PHEMCE Implementation 
Plan will address the medical countermeasure needs of both the general 
population and those special populations (e.g., children, the elderly, 
pregnant women, immunocompromised individuals, and persons with 
disabilities) for whom efficacy or dosing have not been determined, to 
whom FDA licensure has not been extended, or for whom the use of a 
countermeasure is medically contraindicated. Given the limited 
availability of resources, priority will be given to those medical 
countermeasures that will prevent and treat adverse health effects for 
the greatest number of individuals. Meanwhile, HHS will continue its 
dedication to finding treatment and mitigation solutions for high 
priority threats to all populations.
    Concept of Operations. HHS will develop, and select for 
acquisition, candidate medical countermeasures based on desired product 
characteristics that are most compatible with the current Concept of 
Operations (CONOPs) for public health emergency response at the 
Federal, State, and local levels. For each medical countermeasure, HHS 
will establish civilian CONOPs, including maintenance, utilization 
policies, and deployment plans in the context of available consequence 
mitigation strategies. When feasible, HHS will identify and integrate 
existing CONOPs developed by its Federal partners.\16\ Consistent with 
previously issued material threat determinations, HHS will define 
specific medical countermeasure requirements, including product 
specifications consistent with USG storage plans and operational 
capabilities for deployment \17\ and utilization by Federal, State, and 
local authorities. For example, HHS will favor medical countermeasures 
that people can self-administer (e.g., oral antibiotics) over those 
that require administration by a health care worker. For those medical 
countermeasures that do require a health care worker, HHS will favor 
easily administered medications (e.g., a simple single injection) over 
medications that require intravenous administration, continuous medical 
monitoring, or prolonged courses. Preferred medical countermeasures 
will include products that can be stored at room temperature, have a 
minimum 5-year shelf-life, and are appropriate for use by the vast 
majority of the at-risk population.
---------------------------------------------------------------------------

    \16\ DOD will separately develop its medical countermeasure 
CONOPs for military populations and will work to integrate DOD 
medical countermeasure requirements and product development plans 
with HHS strategies for addressing civilian requirements.
    \17\ Deployment includes the transportation and distribution 
system (both vehicular equipment and human capital) needed to 
distribute the medicines and supplies.
---------------------------------------------------------------------------

    Domestic versus International. The HHS PHEMCE Implementation Plan 
will focus on medical countermeasures needed to protect the domestic 
civilian population. In a global emergency, however, the USG may 
utilize these resources, as feasible and as appropriate, to meet 
critical international needs.
Objective 3. Establish and Prioritize Near-Term, Mid-Term, and Long-
Term Development and Acquisition Programs
    HHS will achieve the optimal state of public health preparedness by 
synchronizing its near-term, mid-term, and long-term investments in the 
research, development, and acquisition of existing as well as novel 
medical countermeasures to effectively prevent, mitigate, and treat the 
dynamic nature of the threat scope. The HHS PHEMCE Implementation Plan 
will address both existing and next generation medical countermeasures. 
HHS will regularly evaluate, on a case-by-case basis, investment 
strategies for long-term maintenance and/or replacement of medical 
countermeasures in the SNS. HHS will establish a research and 
development portfolio that will meet future top priority countermeasure 
gaps.
    Building on the existing USG infrastructure, HHS will identify and 
support the critical framework necessary to enable medical 
countermeasure development, including biocontainment facilities, animal 
models, workforce training and education, and product manufacturing. 
HHS will establish strategies that consider the total life-cycle costs 
\18\ of

[[Page 13113]]

each medical countermeasure and will employ the following guidelines 
and principles to evaluate potential investments in the near-term, the 
mid-term, and the long-term.
---------------------------------------------------------------------------

    \18\ Relevant cost elements including development, acquisition, 
storage, maintenance, deployment, utilization, industrial warm-base, 
and disposal of expired items.
---------------------------------------------------------------------------

    Near-term Strategies (FY07-08). Recognizing the broad spectrum of 
CBRN threats and the limited resources available, all investments will 
focus on those threats with the highest possibility for medical 
mitigation. Currently available medical countermeasures will be 
considered for acquisition if they meet immediate, critical needs and 
if they can be deployed effectively under current preparedness plans. 
HHS will continue to invest in research and development activities to 
identify additional indications for currently approved \19\ products. 
Furthermore, HHS will continue to support candidate medical 
countermeasures already in advanced development that have the potential 
to address current vulnerabilities. These efforts will focus on the 
highest priority gaps in terms of adverse public health and medical 
outcomes.
---------------------------------------------------------------------------

    \19\ The term ``approved'' is used broadly in this report to 
refer to products and uses that FDA has approved, licensed, or 
cleared under sections 505, 510(k), and 515 of the Federal Food, 
Drug, and Cosmetic Act or that FDA has licensed under section 351 of 
the Public Health Service Act.
---------------------------------------------------------------------------

    Mid-term Strategies (FY09-13). HHS will monitor advances in medical 
countermeasure technology and will provide, through a narrowly focused 
advanced development effort, the support needed to pull promising 
candidate medical countermeasures through the development pipeline. It 
will be accepted that some of these candidate countermeasures and 
platforms may not be deemed suitable for further investment as 
additional data become available; however, this approach is expected to 
result in a net expansion of the pool of medical countermeasure 
candidates. HHS also will work with the private sector to support new 
technologies for medical countermeasure manufacturing that may be 
utilized for both CBRN and commercial interests. Furthermore, HHS will 
support the development of point-of-care assays and diagnostics, and 
other medical countermeasure products that facilitate a rapid public 
health response, such as those with needle-less delivery systems or 
single dose solutions.
    Long-term Strategies (FY14-23). HHS will maintain its commitment to 
providing appropriate resources to address those threat agents deemed 
by DHS to pose the greatest risks to national security. In addition to 
these known dangers, HHS will continue to work to protect the Nation 
from unknown threats. HHS will also continue its support of the 
development of novel, broad-spectrum medical countermeasures as well as 
innovative approaches to countermeasure deployment logistics, including 
manufacturing processes, delivery systems, storage requirements, and 
distribution tactics. Maintenance in the SNS of products made with 
existing technologies will be evaluated in the context of availability 
of next generation products and of products made with modernized 
manufacturing technologies. Existing technologies will continue to be 
evaluated for applicability to producing novel medical countermeasures.

Goal 2. Build Balanced, Effective Programs Across the HHS Public Health 
Emergency Medical Countermeasures Enterprise

    The HHS PHEMCE will build and maintain a balanced and effective 
medical countermeasure research, development, and acquisition program. 
Currently, a robust research and early development program exists under 
the leadership of the NIH. In the coming years, HHS will expand on this 
foundation to enhance its ability to pursue an aggressive, integrated, 
and strategic advanced development program using authorities provided 
in the Pandemic and All-Hazards Preparedness Act. The prioritization of 
threat-specific medical countermeasures will be reflected in 
corresponding changes in the NIH's research and development funding 
allocations. Furthermore, HHS will enhance its ability to pursue an 
aggressive and strategic advanced development program as part of the 
comprehensive PHEMCE. ASPR will coordinate biodefense research and 
development at NIH, CDC, and FDA; synchronize funding streams for 
advanced development; and utilize scientific capital and technological 
capability from all Federal government agencies to ensure that the 
necessary medical countermeasure solutions are available to respond to 
and minimize critical public health needs.
    Similarly, HHS will strengthen its execution of medical 
countermeasure procurements. It is expanding its acquisition staff and 
has worked with DHS to streamline the approval process for use of the 
special reserve fund authorized in the Project BioShield Act of 2004. 
For current and future medical countermeasures, HHS will continue to 
establish, in partnership with State and local authorities, CONOPs that 
include maintenance, utilization policies, and deployment plans in the 
context of available consequence mitigation strategies.

Goal 3. Increase Transparency and More Actively Engage the Private 
Sector

    The development of new medical countermeasures requires effective 
interactions among Government, the private sector, and academia. 
Private research organizations, pharmaceutical manufacturers, 
biotechnology companies, and clinical research organizations already 
have many of the resources and the expertise needed to develop medical 
countermeasures; however, they have been reluctant to make substantial 
investments in research and development because of market 
uncertainties. HHS will clearly and publicly articulate its medical 
countermeasure development and acquisition priorities, as well as the 
general timelines associated with addressing these priorities.
    HHS will enhance communication between the Federal government and 
external stakeholders through several mechanisms, including this HHS 
PHEMCE Strategy, the soon-to-be-released HHS PHEMCE Implementation 
Plan, the PHEMCE Stakeholder Workshops, and a dedicated Web site, 
MedicalCountermeasures.gov. HHS's annual Stakeholder Workshops will 
educate the public and promote appropriate discussion of these 
priorities with public and private stakeholders. As needed, HHS will 
also convene other meetings and workshops with representatives from 
relevant industries, academia, and other Federal departments and 
agencies (including the Government and Sector Coordinating Councils 
involved in the development of the National Infrastructure Protection 
Plan), international agencies as appropriate, and other interested 
persons.
    In 2007, HHS will launch MedicalCountermeasures.gov, a secure Web 
site designed to enhance industry's access to and rapid communication 
with the relevant USG agencies regarding medical countermeasure 
development. MedicalCountermeasures.gov will provide frequent updates 
on Federal medical countermeasure activities, and will feature upcoming 
events, pre-solicitation notices, key Federal resources, announcements, 
and links to related USG Web sites. Conversely, stakeholders will be 
able to use MedicalCountermeasures.gov to submit information on their 
products in development as well as to request meetings with USG 
departments or agencies.

[[Page 13114]]

    As required by the Pandemic and All-Hazards Preparedness Act, HHS 
will establish the National Biodefense Science Board (NBSB) to provide 
expert advice and guidance to the HHS Secretary on scientific, 
technical, and other matters of special interest to HHS regarding 
current and future CBRN agents, whether naturally occurring, 
accidental, or deliberate. The membership of the NBSB will be comprised 
of the Nation's preeminent scientific, public health, and medical 
experts; Federal officials as the Secretary may determine are necessary 
to support the functions of the Board; individuals representing the 
pharmaceutical, biotechnology, and device industries; individuals 
representing academia; and other members as determined appropriate by 
the Secretary, including a practicing healthcare professional and a 
representative from a healthcare consumer organization.
    With diligent respect for confidentiality concerns and Federal 
regulations, HHS will increase the transparency and public visibility 
of processes by which it selects and acquires medical countermeasures. 
Acknowledging industry's risky investments of time, energy, and 
resources, HHS will foster medical countermeasure development by 
removing or lowering obstacles whenever appropriate, including through 
the application of liability protections under the Public Readiness and 
Emergency Preparedness Act (PREP Act) \20\ and, as appropriate and 
necessary, more flexible contracting procedures. In addition to 
granting the HHS Secretary limited antitrust exemption authorities 
regarding medical countermeasure research and development, the Pandemic 
and All-Hazards Preparedness Act allows the Secretary to make 
milestone-based awards and payments to biotechnology companies and 
pharmaceutical manufacturers.
---------------------------------------------------------------------------

    \20\ On December 30, 2005, President George W. Bush signed into 
law the Public Readiness and Emergency Preparedness Act (PREP Act) 
as part of the 2006 Defense Appropriations Act.
---------------------------------------------------------------------------

Goal 4. Develop, Recruit, and Support a World-Class Workforce

    A successful PHEMCE relies on a highly qualified and accomplished 
workforce with appropriate technical training, scientific skills, and 
business management experience--both within the public and the private 
sectors. HHS is committed, as is each of its Federal partners in this 
endeavor, to continued staffing of the PHEMCE with outstanding 
professionals and to maintaining a work environment conducive to high 
performance. The Department will continue to recruit outstanding 
professionals from both the public and private sectors to build a model 
program for advanced product development, procurement, and delivery 
that will provide needed products as efficiently and effectively as 
possible. HHS will recruit Federal employees (civil service and the 
U.S. Public Health Service) for their experience, skills, and expertise 
in research, development, and the regulatory aspects of product 
development programs, as well as management of such government 
programs. Highly qualified researchers, clinicians, and managers from 
academia and private industry will complement their expertise. HHS will 
facilitate the appointment of these individuals through existing 
general and senior service programs.
    HHS also will develop programs to train professionals at all career 
stages in the foundations of the PHEMCE, utilizing mechanisms such as 
fellowships, sabbaticals, internships, and exchange programs. This 
effort will allow private sector individuals to bring new skills and 
fresh ideas to the program from the biotechnology and pharmaceutical 
industries. The Department also will create appropriate career paths to 
provide PHEMCE staff with opportunities to continue to grow 
professionally, to retain outstanding staff, and to ensure that 
excellence remains a PHEMCE hallmark.
    HHS will use all available Federal hiring practices and all 
Pandemic and All-Hazards Preparedness Act authorities to offer 
compensation that attracts the best human capital to meet its mission 
and challenges. HHS also will identify qualified individuals with 
special expertise who are willing to serve on advisory boards or 
committees that the Secretary determines would contribute to the 
overall program.

Conclusion

    This HHS PHEMCE Strategy reflects the new HHS approach to the 
development, acquisition, and use of medical countermeasures against 
CBRN threats. It provides strategic direction to the Department, 
signals the Department's intents and priorities to its Governmental and 
private partners, and guides the development of the HHS PHEMCE 
Implementation Plan. Consistent with its stated commitment to 
transparency, predictability, and wide-ranging solicitation of 
expertise, the Department will continue to engage stakeholders as it 
develops specific strategic initiatives to meet its goals and 
objectives for the advanced development, procurement, and delivery of 
medical countermeasures. The HHS PHEMCE Strategy underscores the 
commitment by the top leadership of HHS to achieve the vision 
articulated in the President's National Strategy for Medical 
Countermeasures against Weapons of Mass Destruction. It seeks to craft 
and execute a robust, integrated, and end-to-end Public Health 
Emergency Medical Countermeasure Enterprise that provides the Nation 
with an ``all hazards'' capability to protect against, respond to, and 
enable recovery from chemical, biological, radiological, or nuclear 
attacks upon the public health.

    Dated: March 15, 2007.
Gerald Parker,
Principal Deputy Assistant Secretary, Office of the Assistant Secretary 
for Preparedness and Response, Department of Health and Human Services.
 [FR Doc. E7-5066 Filed 3-19-07; 8:45 am]
BILLING CODE 4150-37-P