Federal Register / Vol. 72, No. 53 / Tuesday, March 20, 2007 / Notices 13109 

1http://www.whitehouse.gov/news /releases/ 

2002/12/WMDStrategy.pdf. 2http://www.whitehouse.gov/homeland/ 

20040430.html. 

3http://www.whitehouse.gov/news/ releases/ 

2007/02/20070207–2.html. 

4Federal Register, Vol. 71, No. 129, Thursday, 

July 6, 2006, Notices. 

5Formerly 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). 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

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question whether the proposal complies 

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BHC Act. Additional information on all 

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Center website at www.ffiec.gov/nic/. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than April 3, 2007. 

A. Federal Reserve Bank of 

Richmond (A. Linwood Gill, III, Vice 

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Richmond, Virginia 23261-4528: 

1. PSB Holding Corp., Preston, 

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pursuant to section 225.28(b)(1) of 

Regulation Y. 

Board of Governors of the Federal Reserve 

System, March 14, 2007. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc.E7–4981 Filed 3–19–07; 8:45 am] 

BILLING CODE 6210–01–S 

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. 

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 


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13110 Federal Register / Vol. 72, No. 53 / Tuesday, March 20, 2007 / Notices 

6http://frwebgate.access.gpo.gov/cgi-bin/ 

getdoc.cgi?dbname=108_ 

cong_public_laws&docid=f:publ090.108.pdf. 

7To 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. 

8The 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. 

9A 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. 

10This 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. 

strategies for medical countermeasures 

held in the Strategic National Stockpile 

(SNS). 

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. 

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). 

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. 

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 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 53 / Tuesday, March 20, 2007 / Notices 13111 

11Partners 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). 

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. 

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. 

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 NonMedical 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. 

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, postevent diagnostics, prophylaxis, and/or 

treatment are likely to be the preferred 

strategies for most threats; however, preevent 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 Syndromeassociated 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 


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13112 Federal Register / Vol. 72, No. 53 / Tuesday, March 20, 2007 / Notices 

14Relman 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. 

15Platform technologies are methods for 

developing and producing medical 

countermeasures that are rapidly adaptable to 

multiple threats. 

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. 

18Relevant cost elements including development, 

acquisition, storage, maintenance, deployment, 

to focus on addressing specific, highpriority 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. 

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. 

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 AllHazards 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. 

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 


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Federal Register / Vol. 72, No. 53 / Tuesday, March 20, 2007 / Notices 13113 

utilization, industrial warm-base, and disposal of 

expired items. 

19The 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. 

each medical countermeasure and will 

employ the following guidelines and 

principles to evaluate potential 

investments in the near-term, the midterm, and the long-term. 

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. 

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 pointof-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-bereleased 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, presolicitation 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. 


pwalker on PROD1PC71 with NOTICES
13114 Federal Register / Vol. 72, No. 53 / Tuesday, March 20, 2007 / Notices 

20On 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. 

As required by the Pandemic and AllHazards 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 AllHazards Preparedness Act allows the 

Secretary to make milestone-based 

awards and payments to biotechnology 

companies and pharmaceutical 

manufacturers. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Notice of Public 

Input Opportunity 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) announces the following 

availability of opportunity for the public 

to provide input regarding the draft 

document, ‘‘Long-Term Field Evaluation 

(LTFE) Program Concept.’’

NIOSH is the Federal agency 

responsible for conducting research and 

making recommendations for the 

approval for self-contained, self-rescuer 

(SCSR) closed circuit escape respirators, 

Title 42, Code of Federal Regulations 

(CFR), Part 84. 

The LTFE program for self-contained 

self-rescuers (SCSRs) for miners was 

initiated more than 20 years ago by the 

U.S. Bureau of Mines. The objective for 

the LTFE program is to obtain data to 

determine the expected performance 

characteristics of SCSRs used in the 

mining industry. LTFE program results 

based on scientific principles can 

provide useful information to monitor 

expected SCSR performance and assess 

possible degradation due to the physical 

stresses of in-mine use. Of utmost 

concern is the successful performance of 

any SCSR that passes its inspection 


pwalker on PROD1PC71 with NOTICES