Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20117 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (DHHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold a meeting 

by conference call. The meeting is open 

to the public. 

DATES: The meeting will be held on May 

11, 2007, from 1 p.m. to 2:30 p.m. 

ADDRESSES: This meeting will be held 

by conference call. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Emma English, Program Analyst, 

National Vaccine Program Office, 

Department of Health and Human 

Services, Room 443–H Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201; 

(202) 690–5566, nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Service 

Act (42 U.S.C. Section 300aa–1), the 

Secretary of Health and Human Services 

was mandated to establish the National 

Vaccine Program to achieve optimal 

prevention of human infectious diseases 

through immunization and to achieve 

optimal prevention against adverse 

reactions to vaccines. The NVAC was 

established to provide advice and make 

recommendations to the Assistant 

Secretary for Health, as the Director of 

the National Vaccine Program, on 

matters related to the program’s 

responsibilities. 

This is a special meeting of the 

NVAC. Discussions will surround a 

draft document titled ‘‘The Promise and 

Challenge of Adolescent 

Immunization,’’ prepared at the request 

of the Assistant Secretary for Health by 

the Committee’s Adolescent 

Immunization Working Group. The 

Committee will review the draft 

document and the Committee will vote 

to either endorse the document as an 

official NVAC report or request that 

further revisions be made to the 

document by the Working Group. A 

copy of this draft document can be 

found on the World Wide Web (http:// 

www.hhs.gov/nvpo) or by contacting the 

contact person identified above. 

For this special meeting, remote 

participation will be made available via 

a toll-free call-in phone number. This 

call-in number can be obtained from the 

contact person identified above and will 

be operator assisted to provide members 

of the public the opportunity to provide 

comments to the Committees. Members 

of the public will have the opportunity 

to provide comments at the meeting. 

Public comment will be limited to five 

minutes per speaker. Any members of 

the public who wish to have printed 

written comment made available to the 

Committee members should submit 

materials to the Executive Secretary, 

NVAC, through the contact person listed 

above prior to close of business May 7, 

2007. Any written materials submitted 

by the public that are to be discussed by 

the Committee will be made available 

via the World Wide Web (http:// 

www.hhs.gov/nvpo) prior to the 

meeting. 

Dated: April 17, 2007. 

Raymond Strikas, 

Medical Advisor, National Vaccine Program 

Office. 

[FR Doc. E7–7682 Filed 4–20–07; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Assistant Secretary for 

Preparedness and Response; HHS 

Public Health Emergency Medical 

Countermeasures Enterprise 

Implementation Plan 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. The HHS Public 

Health Emergency Medical 

Countermeasures Enterprise (PHEMCE) 

has taken a holistic, end-to-end 

approach that considers multiple 

aspects of the medical countermeasures 

mission including research, 

development, acquisition, storage, 

maintenance, deployment, and guidance 

for utilization. Phase one of this 

approach established the HHS PHEMCE 

Strategy for Chemical, Biological, 

Radiological, and Nuclear Threats (HHS 

PHEMCE Strategy). The HHS PHEMCE 

Strategy, published in the Federal 

Register on March 20, 2007, described 

a framework of strategic policy goals 

and objectives for identifying medical 

countermeasure requirements and 

establishing priorities for medical 

countermeasure evaluation, 

development and acquisition. These 

strategic policy goals and objectives 

were used to establish the Four Pillars 

upon which this HHS Public Health 

Emergency Medical Countermeasures 

Enterprise Implementation Plan (HHS 

PHEMCE Implementation Plan) is 

based. The HHS PHEMCE 

Implementation Plan considers the full 

spectrum of medical countermeasuresrelated activities, including research, 

development, acquisition, storage/ 

maintenance, deployment, and 

utilization. The HHS PHEMCE 

Implementation Plan is consistent with 

the President’s Biodefense for the 21st 

Century and is aligned with the National 

Strategy for Medical Countermeasures 

against Weapons of Mass Destruction. 

DATES: This notice is effective as of 

April 16, 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. 

HHS PHEMCE Approach to Medical 

Countermeasures 

The United States faces serious public 

health threats from the deliberate use of 

chemical, biological, radiological, or 

nuclear (CBRN) threat agents by hostile 

states or terrorists, and from naturally 

emerging infectious diseases that have 

the potential to cause illness on a scale 

that would impact national security. 

Within the Federal government, the 

mission of the Department of Health and 

Human Services (HHS) is to protect the 

civilian population by providing 

leadership in research, development, 

acquisition, deployment, and guidance 

for effective use of medical 

countermeasures for mitigation of CBRN 

events. This key role was identified in 

the National Strategy to Combat 

Weapons of Mass 


jlentini on PROD1PC65 with NOTICES
20118 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 

1www.whitehouse.gov/news/releases/2002/12/ 

WMDStrategy.pdf. 

2www.whitehouse.gov/homeland/20040430.html. 

3www.whitehouse.gov/news/releases/2007/02/ 

20070207–2.html. 

4http://frwebgate.access.gpo.gov/cgi-bin/

getdoc.cgi?dbname=108_cong_public_laws

&docid=f:publ276.108.pdf. 

5The Project BioShield Annual Report to 

Congress July 2004–July 2006 is available at 

http://www.hhs.gov/aspr/ophemc/bioshield/bio

shieldreport/index.html 

6See http://www.FDA.gov for further information 

regarding the Investigational New Drug application 

and the Emergency Use Authorization 

Destruction,1 Biodefense for the 21st 

Century,2 and the National Strategy for 

Medical Countermeasures against 

Weapons of Mass Destruction,3 which 

together comprise the national blueprint 

for addressing CBRN defense. 

The HHS Public Health Emergency 

Medical Countermeasures Enterprise 

(HHS PHEMCE) leads the mission to 

develop and acquire medical 

countermeasures that will improve 

public health emergency preparedness 

as well as prevent and mitigate the 

adverse health consequences associated 

with CBRN and naturally occurring 

threats. HHS PHEMCE is a coordinated, 

intra-agency effort led by the Office of 

the Assistant Secretary for Preparedness 

and Response (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). Additionally, 

HHS PHEMCE collaborates with its ex 

officio members: The Department of 

Defense (DOD), the Department of 

Homeland Security (DHS), the 

Department of Veterans Affairs (VA) and 

other interagency stakeholders as 

appropriate. 

The HHS PHEMCE Implementation 

Plan for CBRN Threats addresses twelve 

biological threat agents, a class of 

chemical threats (volatile nerve agents) 

and radiological and nuclear threats. 

The medical countermeasure programs 

described will involve the full range of 

activities from research through 

advanced development, acquisition, 

storage, maintenance, deployment and 

utilization and will include all of the 

PHEMCE. However, the detailed focus 

of this Plan will be on the acquisition 

phase using the remaining funds 

available under Project BioShield, 

recognizing that significant efforts both 

upstream and downstream of the 

acquisition will be required to ensure 

the successful development, 

maintenance and utilization of these 

critical response assets, that may be 

needed in the event of a public health 

emergency. 

The HHS PHEMCE Implementation 

Plan for CBRN Threats excludes 

pandemic influenza, which is addressed 

in the HHS Pandemic Influenza Plan. 

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. Significant 

progress has been made in the 

development and acquisition of medical 

countermeasures for pandemic 

influenza. Additional detailed 

information is available at http:// 

www.pandemicflu.gov. 

Current State of Medical 

Countermeasure Preparedness 

To date, HHS has significantly 

expanded national medical 

countermeasure preparedness utilizing 

significant investments from throughout 

the HHS PHEMCE, including NIH 

research and development; CDC 

Division of the Strategic National 

Stockpile (DSNS) acquisition, storage, 

and maintenance of medical 

countermeasures; and substantive 

technical and regulatory support 

provided by FDA to product developers. 

Funding support by the NIH for basic 

research, product development, and 

clinical research of CBRN medical 

countermeasures has increased 

dramatically between Fiscal Year 2001 

(FY 2001) to FY 2006. Funding for the 

DSNS has increased more than ten-fold 

in that same period, providing for the 

acquisition and stockpiling of medical 

countermeasures and supplies to protect 

the American public. Furthermore, the 

Project BioShield Act of 2004 (Pub. L. 

108–276) 4 (Project BioShield) was 

enacted to accelerate the acquisition and 

availability of safe and effective medical 

countermeasures to protect the United 

States from CBRN threats. Project 

BioShield created a $5.6 billion Special 

Reserve Fund (SRF) for use over 10 

years (FY 2004–FY 2013) to acquire 

appropriate medical countermeasures 

for DSNS. 

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 and for which there were 

opportunities to have a significant 

impact on improving preparedness. 

These products included medical 

countermeasures for anthrax, smallpox, 

botulinum toxins, and radiological/ 

nuclear agents—the four threat agents 

initially determined by DHS to pose a 

material threat to national security.5

Acquisitions under Project BioShield to 

date include the currently licensed 

anthrax vaccine, anthrax therapeutics 

(monoclonal and human immune 

globulin), a pediatric formulation of 

potassium iodide to protect against 

absorption of radioactive iodine, 

calcium and zinc 

diethylenetriaminepentaacetate (DTPA), 

chelating agents to treat ingestion of 

certain radiological particles, and 

botulinum antitoxin. 

Additional acquisitions of medical 

countermeasures for the DSNS have also 

provided a substantial preparedness 

level for a number of material threats. 

Specifically, DSNS inventory includes 

smallpox vaccine to immunize every 

American and Vaccinia Immune 

Globulin to treat complications that may 

arise from smallpox vaccination; 

anthrax therapeutics and a substantial 

level of antibiotics to provide treatment 

(thousands of doses) or prophylaxis 

(millions of doses) for bacterial threat 

agents anthrax, plague and tularemia; 

thousands of treatment courses of the 

chelating agent Prussian Blue (which 

mitigates internal absorption of cesium137, a component of dirty bombs); 

enough potassium iodide tablets (which 

protects against radioactive iodine) for 

over one million people; thousands of 

courses of growth factors that could be 

useful for addressing the hematopoietic 

effects of acute radiation syndrome 

(ARS); CHEMPACKs (pre-positioned 

antidotes for volatile nerve agent 

exposure) distributed throughout the 

country; and general supplies that will 

be required to treat the complex array of 

medical problems following a nuclear 

attack, including antibiotics, anti-nausea 

drugs, and large quantities of supplies to 

treat burn and blast injuries. Some of 

these stockpiled products are licensed, 

approved, or cleared by FDA for use as 

medical countermeasures. Others are 

investigational and would need to be 

used under an Investigational New Drug 

application or an Emergency Use 

Authorization 6. In 2002, DSNS began 

participating in the Shelf Life Extension 

Program (SLEP) with FDA. SLEP allows 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20119 

7As defined in the Pandemic and All-Hazards 

Preparedness Act (P.L.109–417), which is available 

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

getdoc.cgi?dbname=109_cong_public_laws&docid=

f:publ417.109.pdf. 

8Available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=2007_register&docid=%

5bDOCID:fr20mr07–65. 

9http://www.fbo.gov/servlet/Docments/R/589030. 

10Material Threat Determinations are authorized 

under section 319 F–2(c)(2) of the Public Health 

Service Act, as added by section 3 of the Project 

BioShield Act and are a legally required precursor 

to procurements under that authority. 

the extension of the expiration date of 

certain drugs in DSNS where adequate 

supporting data exist, so that critical 

medical countermeasures that are still 

safe and effective can continue to be 

used. 

HHS has also acted to improve and 

strengthen the underlying national 

response capacity and distribution 

efficiency that is required to take full 

advantage of these stockpiled medical 

countermeasures. HHS has specifically 

worked to prepare public health systems 

for bioterrorism and other mass casualty 

incidents; expand America’s public 

health laboratory capacity, a crucial 

element in detecting and understanding 

any disease outbreak; expand and 

improve communications capacity 

within the public health structure to 

make public communications clearer 

and faster in an emergency; enhance 

food defense and safety activities at the 

FDA; expand the biodefense research 

program at NIH; and address response 

capacity for at-risk populations 

including children, pregnant women, 

senior citizens and other individuals 

who have special needs in the event of 

a public health emergency, as 

determined by the Secretary.7

Development of the HHS PHEMCE 

Implementation Plan For Chemical, 

Biological, Radiological and Nuclear 

Threats 

HHS approached the development of 

the HHS PHEMCE Implementation Plan 

recognizing that the past investments 

outlined above have resulted in an 

armamentarium of medical 

countermeasures in DSNS that provides 

a substantial preparedness level for a 

number of CBRN threats. HHS 

recognizes that while it was important 

to achieve the current level of 

preparedness, it is equally as important 

to maintain and improve this capability. 

HHS PHEMCE has taken a holistic, 

end-to-end approach that considers 

multiple aspects of the medical 

countermeasures mission including 

research, development, acquisition, 

storage, maintenance, deployment, and 

guidance for utilization. Phase One of 

this approach established the HHS 

Public Health Emergency Medical 

Countermeasures Enterprise Strategy for 

Chemical Biological, Radiological and 

Nuclear Threats (HHS PHEMCE 

Strategy).8 The September 2006 

BioShield Stakeholders Workshop 

brought together stakeholders from all 

aspects of the mission to discuss the 

framework and approach for the HHS 

PHEMCE Strategy. The valuable input 

solicited from stakeholders at the 

Workshop, combined with the 

responses received to the medical 

countermeasures Request for 

Information issued in October 2006 9

and through the Federal Register, was 

incorporated into the HHS PHEMCE 

Strategy. 

The HHS PHEMCE Strategy, 

published in the Federal Register on 

March 20, 2007, described a framework 

of strategic policy goals and objectives 

for identifying medical countermeasure 

requirements and establishing priorities 

for medical countermeasure evaluation, 

development and acquisition. These 

strategic policy goals and objectives 

were used to establish the Four Pillars 

upon which this HHS PHEMCE 

Implementation Plan is based. 

Pillar One: Identify and Assess CBRN 

Threats 

DHS leads the Federal response to 

National Response Plan incidents, 

conducts integrated assessments of the 

risks posed by CBRN agents, and issues 

Material Threat Determinations (MTDs) 

as to which CBRN pose a material threat 

sufficient to affect U.S. national 

security.10 The Secretary of Homeland 

Security has issued MTDs for threat 

agents (Table 1) and has conducted 

Population Threat Assessments (PTA) to 

estimate the number of individuals who 

might be exposed to each of these 

threats in plausible, high-consequence 

scenarios. A Population Threat 

Assessment has been conducted for 

volatile nerve agents. 

In the future, additional MTDs may be 

issued if technology advances or if our 

understanding of the potential threats 

changes. The PHEMCE strategy is to 

have specific medical countermeasures 

that address each of the threats for 

which an MTD has been issued while 

also providing broad spectrum medical 

countermeasures to address as many as 

is practicable of those threats that did 

not rise to the level of an MTD. 

Pillar Two: Assess Medical/Public 

Health Consequences 

The information supporting the MTDs 

and PTAs regarding population 

exposures from high consequence 

scenarios provided by DHS is used by 

HHS to inform subsequent medical and 

public health consequence assessments 

using multiple sources of information, 

including modeling. HHS uses modeling 

to help to explore potential outcomes 

when medical countermeasures are 

employed in operationally realistic 

timelines. The HHS assessments 

provide public health impact estimates 

for a given threat scenario and use of 

medical countermeasures for each threat 

agent. 


jlentini on PROD1PC65 with NOTICESEN23AP07.000</GPH>
20120 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 

11 Including subject matter experts from HHS 

(CDC, FDA, and NIH), DOD, DHS, VA, and the 

respective HHS PHEMCE Chemical, Biologics, 

Radiological and Nuclear Working Groups. 

12The authority of the Secretary of HHS to deploy 

the SNS is codified at 42 U.S.C. § 247d–6b. 

Pillar Three: Establish Medical 

Countermeasure Requirements That 

Incorporate Assessments of Current 

Levels of Preparedness, Concepts of 

Utilization, and Product Specifications 

Our current state of preparedness and 

medical countermeasure requirements 

have been assessed for these fourteen 

CBRN threats. To establish medical 

countermeasure requirements for the 

top priority threat agents, HHS 

combines the threat prioritization and 

medical and public health consequence 

assessments, along with subject matter 

expert evaluations, domestic and 

international intelligence information, 

and information on current State, local 

and tribal response capabilities. 

Pillar Four: Identify and Prioritize

Near-, Mid-, and Long-Term 

Development and Acquisition Programs, 

Informed by Assessment of the Maturity 

of the Product Development Pipeline 

and Estimated Costs 

The mission to develop and acquire 

agent-specific medical countermeasures 

for the entire U.S. population for all 

fourteen threats and broad spectrum 

medical countermeasures against the 

remaining current and future threats 

encompasses a vast range of activities 

and dictates priority-setting. The 

process for setting the priorities for the 

portfolio of investments ultimately 

outlined in this plan required careful 

consideration and deliberation. 

Specifically, HHS PHEMCE evaluated 

three possible approaches during the 

priority setting process. The first option 

was to focus only on a single, highest 

priority threat. In line with this, all 

available acquisition dollars would be 

spent trying to fully address the 

requirements for this one agent with the 

aim of eliminating it as a material threat 

to national security. The second option 

was to divide the available resources 

equally among the known fourteen 

threats. The third option, and the 

approach that the PHEMCE ultimately 

pursued, was to prioritize strategic 

policy decisions, framed by the HHS 

PHEMCE Strategy, which will most 

effectively improve overall public 

health preparedness. This decisionmaking process to set priorities 

included extensive discussion with 

Federal government subject matter 

experts 11 and was guided by the 

principles of the National Strategy for 

Medical Countermeasures against 

Weapons of Mass Destruction. As a 

result, HHS has prioritized the medical 

countermeasures programs—including, 

research, development, and acquisition 

in the near-term, mid-term and longterm—that were determined to provide 

the greatest opportunities to improve 

public health emergency preparedness 

across the threat spectrum. 

The key elements that established the 

foundation for the priority-setting 

decisions were as follows: 

Prevention Versus Mitigation and 

Treatment 

HHS has generally adopted a strategy 

of developing and acquiring medical 

countermeasures for post-event 

response to CBRN threats. Preventive 

measures are appropriate only for 

threats of such potential catastrophic 

consequence that a pre-event strategy 

will be examined in order to reduce 

vulnerability and mitigate post-event 

consequences. Therapeutics and 

diagnostics or the use of post-event 

prophylaxis will be the preferred 

strategy for all other threats. Priority 

will be placed on medical 

countermeasures that focus on postevent prophylaxis or post-exposure 

treatment. 

Concept of Operations 

In alignment with the National 

Strategy for Medical Countermeasures 

against Weapons of Mass Destruction, 

HHS will prioritize the development 

and acquisition of medical 

countermeasures that are associated 

with an effective concept of operations 

(CONOPs). These CONOPs include a 

deployment strategy and utilization 

policy that is supportable by the present 

and future programmed distribution 

capabilities of Federal, State, local, and 

tribal public health emergency 

responders to rapidly ship and 

distribute critical items following a 

CBRN event. Within HHS, ASPR 

coordinates with the CDC Coordinating 

Office for Terrorism Preparedness and 

Emergency Response (COPTER) in 

determining processes, procedures, 

tactics, and techniques for how DSNS 

deploys countermeasures 12 and the 

utilization strategies for those materials 

and medical countermeasures. ASPR’s 

Office of Preparedness and Emergency 

Operations (OPEO) works with its 

response partners, using event and 

response modeling, to outline how the 

current DSNS inventory will be used. 

These approaches are exercised with 

interagency partners to ensure that the 

plans are based on realistic and 

achievable timelines. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20121 

13Relman 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. 

14As defined in the National Strategy for Medical 

Countermeasures against Weapons of Mass 

Destruction: Enhanced Agents are traditional agents 

that have been modified or selected to enhance 

their ability to harm human populations or 

circumvent current countermeasures, such as a 

bacterium that has been modified to resist antibiotic 

treatment; Emerging Agents are previously 

unrecognized pathogens that might be naturally 

occurring and present a serious risk to human 

populations, such as the virus responsible for 

Severe Acute Respiratory Syndrome (SARS); and 

Advanced Agents are novel pathogens or other 

materials of biological nature that have been 

artificially engineered in the laboratory to bypass 

traditional countermeasures or produce a more 

severe or otherwise enhanced spectrum of disease. 

15Examples of platform technologies include 

strategies that permit rapid commercial scale 

production of threat-specific countermeasures or 

expression systems that permit rapid production of 

new vaccines. 

16SRF that supports Project BioShield released 

$3.4 billion for use between FY 2004–2008 and the 

remaining $2.2 billion will be available for use 

between FY 2009–2013. 

17Non-exposed population seeking medical care 

for non-specific symptoms or concerns about 

exposure. 

18A production process in which an increase in 

the number of units produced causes a decrease in 

the average cost of each unit. 

19www.whitehouse.gov/ news/releases/2007/ 02/ 

20070207-2.html. 

The CONOPs for a particular threat 

scenario and medical countermeasure 

are a crucial component in setting 

specific product requirements and 

contribute directly to the acquisition 

strategy. While there is much in 

common in medical countermeasure 

development for civilian and military 

medical countermeasures, CONOPs for 

HHS and DOD, respectively, have 

differences which must be considered in 

the requirements and acquisitions 

processes. HHS is committed to 

continuing to work with all its 

emergency responder partners to 

improve public health response 

capabilities. 

Broad Spectrum Medical 

Countermeasures and Platform 

Technologies 

A fixed defense 13 or ‘‘one-bug, onedrug’’ approach for medical 

countermeasure development is 

determined to be effective and viable for 

some of the highest priority threats such 

as smallpox and anthrax. As the list of 

material threats increases, and 

technology advances, HHS will be 

focusing its medical countermeasure 

research, development and acquisition 

efforts on broad spectrum and platform 

approaches. 

Preparing for New Threats 

In order to address emerging, 

enhanced, and advanced threats,14 HHS 

will be investing in research and 

development on innovative approaches 

and platform technologies.15 These 

technologies will facilitate rapid 

identification and characterization of 

novel threat agents, thereby creating the 

capability to rapidly produce relevant 

medical countermeasures. This policy is 

aligned with the National Strategy for 

Medical Countermeasures against 

Weapons of Mass Destruction which 

targets the use of existing, proven 

approaches for developing medical 

countermeasures to address challenges 

posed by traditional CBRN agents while 

calling for a flexible capability to 

develop new medical countermeasures. 

These latter activities emphasize the 

need to capitalize upon the 

development of innovative and future 

technologies that will enhance our 

ability to respond swiftly and effectively 

to potential, emerging, and future 

unknown CBRN threats. This will 

require targeted, balanced, and 

sustained investments to support 

fundamental basic research to discover 

new technologies and update platforms 

as well as applied research for 

technology development to deliver new 

medical capabilities and 

countermeasures. 

Top Priority Medical Countermeasure 

Research, Development, and 

Acquisition Programs to Increase 

Public Health Emergency Preparedness 

Following the principles and 

processes described above, HHS has 

assessed the top priority CBRN threats 

from a medical countermeasure 

perspective and has developed medical 

countermeasure acquisition priorities 

for the near-term (FY 2007–FY 2008), 

the mid-term (FY 2009–FY 2013), and, 

in less detail, the long-term (beyond FY 

2013).16 This prioritization spans the 

CBRN threat spectrum and best utilizes 

available resources in addressing the 

highest priority threats to maximize risk 

mitigation. Table 2 arrays the top 

priority medical countermeasure 

programs against the specific threat 

agents addressed by the program. The 

broad spectrum antibiotic, broad 

spectrum antiviral, and diagnostics 

programs address multiple threat agents, 

while other programs are, of necessity, 

agent-specific. 

Medical countermeasure requirements 

are based primarily on the number of 

persons exposed to clinically significant 

levels of a threat agent in a single-event, 

plausible, high-consequence scenario. In 

setting appropriate targets for an 

acquisition program, a number of factors 

in addition to the single event, 

exposure-based medical countermeasure 

requirement could be considered, 

including: 

• Multiple events 

• Citizens concerned about 

exposure 17

• The lack of availability of rapid, 

point-of-care diagnostics 

• Potential nationwide demand after 

a single large-scale event 

• Pre-positioning of individual 

medical countermeasures to meet 

specific response time requirements 

• Economies of scale for 

production 18

• Providing a target acquisition size 

sufficient to drive industrial 

development of the medical 

countermeasure. 

HHS will continue to coordinate 

medical countermeasure development 

and acquisition efforts with DOD; 

however, separate development and 

acquisition programs may be necessary 

in situations where military 

requirements differ from civilian 

requirements, including with regard to 

concepts of use of particular 

countermeasures. Consistent with the 

National Strategy for Medical 

Countermeasures against Weapons of 

Mass Destruction, the Secretary of 

Health and Human Services is tasked 

with civilian medical countermeasure 

preparedness, and it is National policy 

that ‘‘the Secretary of Defense shall 

retain the exclusive responsibility for 

research, development and acquisition 

of medical countermeasures to prevent 

or mitigate the health effects of WMD 

threats * * * to the Armed Forces.’’ 19

BILLING CODE 4150–37–P 


jlentini on PROD1PC65 with NOTICES
20122 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 

Strategies for Addressing High Priority 

Medical Countermeasures 

Research and Development 

NIH is the lead agency within the 

Federal Government for conducting and 

supporting biomedical research relating 

to causes, diagnosis, treatment, control, 

and prevention of diseases. NIH will 

align research and development efforts 

with the PHEMCE priority medical 

countermeasure programs. In addition, 

NIH will support Research and 

Development for next-generation 

products to replace currently-held 

medical countermeasures in DSNS, as 

needed. These next generation products 

include medical countermeasures with 

broad spectrum activity against a wide 

variety of threat agents; broad spectrum 

technologies that enhance effectiveness 

of multiple classes of medical 

countermeasures; and broad spectrum 

platforms that permit more rapid 

generation of required medical 

countermeasures. Continued research 

and development efforts will ensure a 

sustainable, continuous stream of 

promising medical countermeasures in 

the pipeline that are aligned with top 

priority HHS PHEMCE requirements for 

future acquisitions and/or replacement 

of DSNS inventory. NIH’s long-term 

focus is on platform technologies and 

broad spectrum medical 

countermeasures that will allow for the 

rapid introduction of additional 

response capabilities for emerging 

infectious agents. 


jlentini on PROD1PC65 with NOTICESEN23AP07.001</GPH>
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20123 

20The Pandemic and All-Hazards Preparedness 

Act (Pub. L. 109–417) definition of advanced 

research and development: ‘‘with respect to a 

product that is or may become a qualified 

countermeasure or a qualified pandemic or 

epidemic product, activities that predominantly are 

conducted after basic research and preclinical 

development of the product; and are related to 

manufacturing the product on a commercial scale 

and in a form that satisfies the regulatory 

requirements under the Federal Food, Drug, and 

Cosmetic Act or under section 351 of this Act.’’ 21Often referred to as the ‘‘Valley of Death.’’

Advanced Development 20

The use of advanced development 

efforts that support multiple candidates 

for each medical countermeasure need 

is a key element to mitigating risk in the 

Project BioShield acquisition phase of 

the product development pathway. The 

Pandemic and All-Hazards 

Preparedness Act (Pub. L. 109–417) 

established the Biomedical Advanced 

Research and Development Authority 

(BARDA). Utilizing those tools, HHS 

plans to promote innovation, reduce 

risk to both medical countermeasure 

developers and the Government, and 

invest in medical countermeasure 

advanced development that will carry 

products through the crucial middle 

phase 21 of drug development between 

basic research and acquisition of final 

products. HHS anticipates that available 

funding through these authorities, in FY 

2007 and beyond, will be aligned with 

the highest priority medical 

countermeasure development programs. 

Finally, Advanced Development 

activities will depend on congressional 

approval of the President’s FY 2008 

budget request of $189 million. The 

future funding levels for BARDA remain 

to be determined. 

Projected Acquisitions 

The HHS PHEMCE will consider 

opportunities for acquiring medical 

countermeasures using both DSNS 

appropriations as well as SRF monies 

under Project BioShield. Acquisitions 

under DSNS will be limited to 

commercially available products. 

Current funding levels were considered 

in projecting acquisition forecasts. 

While BARDA funding has been 

established to support the advanced 

development of medical 

countermeasures, Project BioShield 

acquisition contracts may still include 

late-stage development costs for scaleup manufacturing, clinical trials, and 

pivotal animal efficacy studies, in 

addition to final production and 

delivery. 

The near-term is defined as FY 2007–

FY 2008, which is the time frame of 

allocation of approximately half of the 

Project BioShield SRF. The mid-term is 

defined as FY 2009–FY 2013, which is 

the remainder of the ten year duration 

of the Special Reserve Fund. Medical 

countermeasures will be procured in the 

near-term and mid-term using both the 

SRF as well as from the DSNS 

appropriations. During the near-term, 

HHS also will pursue acquiring a 

number of medical countermeasures for 

which utilization of the Project 

BioShield Special Reserve Fund has 

been approved, but for which funds 

have not yet been fully obligated. 

Table 3 summarizes the proposed 

near-term and mid-term acquisitions for 

the priority medical countermeasures. 

In some cases, the estimated funding 

ranges indicated are based on identified 

potential medical countermeasure 

candidates currently under 

development; whereas in other cases the 

estimated ranges are based on industry 

standard information for vaccine and 

drug development costs. Descriptions of 

the acquisitions for priority medical 

countermeasures follow Table 3. 


jlentini on PROD1PC65 with NOTICES
20124 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 


jlentini on PROD1PC65 with NOTICESEN23AP07.002</GPH>
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20125 

PROJECTED NEAR-TERM (FY 2007–FY 

2008) 

Medical Countermeasure Development 

and Acquisition Programs To Enhance 

Preparedness 

Programs for Biological Threats 

Broad Spectrum Antibiotic(s) 

MTD: Bacillus anthracis and multidrug resistant bacillus anthracis, 

burkholderia mallei, burkholderia 

pseudomallei, franciscella tularensis, 

rickettsia prowazekii, yersinia pestis. 

Many of MTDs address bacterial 

species that can be treated using 

antibiotics. Broad spectrum antibiotics, 

therefore, will continue to be a critical 

component of strategy HHS will take to 

maintain and improve public health 

preparedness. For each biological threat 

agent or class of agents, however, there 

is a limited array of antibiotics with 

demonstrated efficacy. In the near-term, 

HHS will continually evaluate the 

antibiotics in the DSNS and, as needed, 

will acquire commercially available 

antibiotics using DSNS appropriations. 

Anthrax Vaccine(s) 

MTD: Bacillus anthracis, multi-drug 

resistant bacillus anthracis. 

Antibiotics represent the first line of 

defense to protect the nation following 

an anthrax attack. However, anthrax 

vaccines are also an essential element of 

our national preparedness. Vaccines 

may be given as post-exposure 

prophylaxis in combination with 

antibiotics to potentially provide longerterm protection; this combination may 

also allow for a reduction in the 

duration of the antibiotic regimen. 

Vaccines can also provide pre-event 

protection to the relatively small 

population that is at high risk of 

frequent occupational exposure to 

Bacillus anthracis. 

In December 2006, a contract for the 

development and acquisition of a 

recombinant Protective Antigen (rPA) 

anthrax vaccine was terminated by 

HHS; however, the Department remains 

committed to acquiring next-generation 

anthrax vaccines that will be part of a 

balanced and diversified portfolio of 

medical countermeasures. HHS has 

developed a comprehensive strategy for 

advanced development and acquisition 

of current and next generation anthrax 

vaccines and anticipates that these 

activities will be pursued in the nearterm. 

Smallpox Vaccine(s) 

MTD: Variola virus. 

HHS has made significant progress in 

providing smallpox vaccine to the 

DSNS. In addition, a requirement has 

been established for a smallpox vaccine 

to protect immunocompromised persons 

for whom use of the existing smallpox 

vaccines is medically contraindicated in 

the absence of smallpox exposure. 

One candidate next-generation 

smallpox vaccine, modified vaccinia 

Ankara (MVA), is based on a strain of 

the vaccinia virus that, in contrast to 

current smallpox vaccines such as 

Dryvax, does not replicate effectively in 

human cells and, therefore, may cause 

fewer side effects. The MVA 

development programs were supported 

by the National Institute of Allergy and 

Infectious Diseases (NIAID) with 

milestone-driven contract awards in 

2003 and 2004. HHS is well-advanced 

in the pre-award stage of an MVA 

vaccine acquisition program. 

Programs for Radiological and Nuclear 

Threats 

ARS/Hematopoietic Syndrome Medical 

Countermeasure(s) 

MTD: Radiological/nuclear agents. 

HHS regards radiological and nuclear 

agents as a significant threat to national 

security and is committed to purchasing 

safe and efficacious medical 

countermeasures to treat Acute 

Radiation Syndrome (ARS). In March 

2007, HHS withdrew the ARS RFP 

because it was determined, after 

extensive scientific and technical expert 

evaluation, that no competing offeror 

had a product that met USG 

requirements for a Project BioShield 

acquisition. HHS will continue to 

pursue an initial acquisition of a safe 

and effective medical countermeasure to 

treat ARS. In moving forward to meet 

this goal, HHS will make use of 

scientific developments that have 

occurred since the previous RFP closed, 

as well as new authorities provided by 

the Pandemic and All-Hazards 

Preparedness Act that could accelerate 

the advanced development of promising 

countermeasures. 

HHS supports further development of 

the radiological and nuclear medical 

countermeasure pipeline. The NIAID’s 

Radiation Countermeasures Research 

Program has funded numerous projects, 

including: ARS medical countermeasure 

screening programs in cell-based and 

rodent models at multiple institutions 

around the country; development of 

three Good Laboratory Practices (GLP) 

animal testing facilities to evaluate the 

efficacy of medical countermeasures 

against ARS; eight Centers for Medical 

Countermeasures against Radiation at 

academic institutions around the 

country; and intramural research 

programs at the DOD Armed Forces 

Radiobiology Research Institute (AFRRI) 

and the National Cancer Institute. 

PROJECTED MID-TERM (FY 2009–FY 

2013) 

Medical Countermeasure Development 

and Acquisition Programs To Enhance 

Preparedness 

HHS will pursue the following 

medical countermeasure acquisitions in 

the mid-term using the remaining SRF 

and pending availability of other 

funding for those acquisitions that do 

not use the SRF. These anticipated 

acquisitions are also predicated on the 

availability of products at the 

appropriate developmental stage that 

meet U.S. Government civilian 

requirements. 

Programs for Biological Threats 

The ideal medical countermeasures 

for biological agents will be highly 

effective for post-exposure prophylaxis 

as well as early symptomatic treatment, 

will display an excellent safety profile 

and could be easily self-administered. 

Broad Spectrum Antibiotic(s) 

MTD: Bacillus anthracis, multi-drug 

resistant bacillus anthracis. 

burkholderia mallei, burkholderia 

pseudomallei, francisella tularensis, 

rickettsia prowazekii, yersinia pestis. 

In addition to the near-term strategy 

for acquisition of commercially 

available antibiotics, HHS anticipates 

maintaining a robust basic research and 

development program along with 

advanced development for broad 

spectrum antimicrobials that will 

specifically provide support for 

regulatory approval for clinical 

indications that address bacterial agent 

MTDs. In order to better balance 

antimicrobial DSNS holdings in light of 

newer MTDs, HHS will pursue a 

potential acquisition of additional broad 

spectrum antimicrobials in the midterm. 

Diagnostics (Point-of-Care) 

MTD: All biological threat agents. 

Following a terrorist event, clinical 

diagnostic assays (in vitro diagnostics, 

IVDs) are critical tools for distinguishing 

infected (symptomatic) individuals 

needing treatment from potentially 

exposed but asymptomatic individuals 

needing post-exposure prophylaxis. 

Overall, the requirements for diagnostic 

assays to facilitate a response to a 

bioterrorism event will focus on rapid, 

point-of-care assays. Rapid triaging of 

the symptomatic patients will be 

required to provide, as necessary, 

treatment, isolation and implementation 

of universal precautions for infectious 

diseases and may also be useful in the 


jlentini on PROD1PC65 with NOTICES
20126 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 

allocation of limited critical therapeutic 

materials to only those patients in need. 

Multiplexed, adaptive platforms that 

confer flexibility, offer alternative 

commercial opportunities, and allow for 

the rapid introduction of additional 

tests for emerging infectious agents are 

highly desired. 

These IVDs used for clinical purposes 

are distinguished from detection assays 

used for environmental samples (air, 

water, food, surface swabs) in that they 

are required to be approved or cleared 

by the FDA. To date, limited incentives 

have been available to sustain 

commercial market production of IVDs; 

however, once specific requirements in 

this area are developed and prioritized, 

HHS will pursue a potential mid-term 

acquisition of biological agent 

diagnostics to enhance public health 

preparedness capability. 

Anthrax Antitoxin 

MTD: Bacillus anthracis, multi-drug 

resistant bacillus anthracis. 

The primary mortality and morbidity 

of anthrax disease is mediated through 

toxins produced by the bacteria, B. 

anthracis. Antibiotics (currently within 

DSNS) target the B. anthracis bacteria 

itself; while vaccines (discussed under 

Near-Term Acquisitions) provide longterm protection from disease. Antitoxins 

are required to neutralize the effects of 

the toxins and may contribute to a more 

successful therapeutic outcome. Given 

the current status of anthrax antitoxins 

and animal model development, HHS 

will continue its phased acquisition 

program and will pursue a mid-term 

acquisition of additional anthrax 

antitoxin to allow HHS to more fully 

meet medical countermeasure 

requirements, including to address the 

threat from MDR anthrax. 

Filovirus Medical Countermeasure(s) 

MTD: Ebola virus, marburg virus. 

Infection with filoviruses produces an 

aggressive disease that is highly lethal. 

Currently, no FDA-approved filovirusspecific medical countermeasures exist. 

An antiviral is preferred to treat infected 

patients and to provide pre-exposure 

prophylaxis to health care workers and 

personal contacts. A vaccine will be 

useful for civilian populations if it 

provides rapid onset of protective 

immunity. HHS will continue to invest 

in research and development and will 

pursue an acquisition for filovirus 

medical countermeasures in the midterm. 

Smallpox Antiviral 

MTD: Variola virus. 

Currently there is no treatment 

available for smallpox disease once the 

symptoms manifest. An effective 

antiviral treatment could mitigate the 

effects of smallpox disease. It is likely 

that such an antiviral may also be 

effective against other pox viruses. 

Given the current status of the most 

advanced products as well as the status 

of animal model development, HHS will 

pursue a mid-term acquisition of a 

smallpox antiviral for the treatment of 

smallpox. The ideal antiviral will be 

highly effective post-exposure as well as 

an effective treatment early in the 

symptomatic phase of the disease. 

Programs for Radiological and Nuclear 

Threats 

ARS/DEARE Medical 

Countermeasure(s) 

MTD: Radiological/nuclear agents. 

Acute Radiation Syndrome (ARS) 

often called radiation sickness, results 

when humans are exposed to a large 

dose of ionizing radiation. ARS 

develops in the timeframe of hours to 

weeks, and the Delayed Effects of Acute 

Radiation Exposure (DEARE) injury in 

weeks to months following radiation 

exposure. HHS will pursue one or more 

ARS/DEARE medical countermeasure 

acquisition(s) in the mid-term to 

continue the phased acquisition strategy 

launched in the near-term. 

Biodosimetry and Bioassay 

MTD: Radiological/nuclear agents. 

Biodosimetry and radionuclide 

bioassay capabilities are essential for 

medical management of ARS/DEARE 

following acute radiation exposure and 

are integral to triage and management 

processes. HHS anticipates that rapid 

biodosimetry assays for on-scene triage 

should be available for acquisition in 

the mid-term. A system of biodosimetry 

and radionuclide bioassay laboratories 

is also proposed to increase overall 

national capacity. While the diagnostics 

portion of this requirement may be 

funded through the Project BioShield 

SRF, appropriate funding to establish 

this laboratory network is yet to be 

determined. 

Radionuclide-Specific Medical 

Countermeasure(s) 

MTD: Radiological/nuclear agents. 

Radionuclide-specific medical 

countermeasures are a key component 

to managing the medical consequences 

of radiation dispersal device (RDD) 

events, both explosive and nonexplosive, as well as nuclear power 

plant events. In the near term, HHS will 

continue to fund the development of 

improved formulations of 

diethylenetriaminepentaacetate (DTPA) 

and other novel decorporating agents 

that remove radioactive particles from 

the body. If continued progress is made 

on the radionuclide-specific 

countermeasures currently under 

development, it is conceivable that oral 

formulations of DTPA (which would 

considerably ease the logistical 

requirements for rapid delivery of this 

medical countermeasure) and/or other 

novel decorporating agents could be 

available for acquisition in the midterm. 

Programs for Chemical Threats 

Enterprise CHEMPACKs 

PTA: Volatile nerve agents. 

The CHEMPACK program is an 

ongoing initiative of the DSNS, begun in 

2003, that provides antidotes (three 

countermeasures used concomitantly) to 

volatile nerve agents for pre-positioning 

by State, local, and/or tribal officials 

throughout the U.S. In its current form, 

the program will receive continued 

funding in the near-term for 

procurement and fielding of additional 

CHEMPACKs, replacement of expired 

product, and administrative support. 

The proposed Enterprise CHEMPACK 

program would build upon the existing 

system, improving it by adding an 

education, training and exercise 

component and by optimizing the prepositioning of antidotes. In the nearterm, HHS will begin performing the 

operations analysis that is prerequisite 

to such improvements. It is anticipated 

that acquisition of some next-generation 

replacement products and the 

implementation of changes to improve 

the program could occur in the midterm, pending availability of DSNS 

funds. 

PROJECTED LONG-TERM (BEYOND 

FY 2013) 

Medical Countermeasure Development 

and Acquisition Programs To Enhance 

Preparedness 

Program for Biological Threats 

Broad Spectrum Antiviral(s) 

MTD: Ebola Virus, Junin Virus, 

Marburg Virus, Variola Virus. 

Three families of viruses are 

represented among the existing MTDs: 

Poxviridae (variola virus), Filoviridae 

(Ebola and Marburg viruses), and 

Arenaviridae (Junin virus). These 

different viral families have diverse 

biological and pathological 

characteristics and cause unique 

diseases in humans. All of these viruses 

can be disseminated via aerosolization, 

a feature which enhances their potential 

use as bioterrorism agents. There are no 

approved antiviral drugs available for 

either post-exposure prophylaxis or for 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 20127 

therapeutic use for any of these viral 

diseases. Overall, the development of 

broad spectrum medical 

countermeasures that can address 

several threat agents would maximize 

the efficiency and flexibility of the 

DSNS, thereby reducing storage and 

maintenance costs. HHS will prioritize 

research and development funding in 

this area in the near- and mid-terms. 

Due to its relative immaturity in the 

development pipeline, it is unlikely that 

a broad spectrum antiviral will be 

acquisition-ready until after FY 2013. 

Program for Chemical Threats 

Volatile Nerve Agent Single Antidote 

PTA: Volatile Nerve Agents. 

The optimal medical defense against 

volatile nerve agents would be a single, 

rapidly effective countermeasure that 

could be used, for example, via 

intranasal or inhaled routes and by 

untrained persons at risk or by first 

responders dealing with large numbers 

of exposed individuals. HHS will 

continue research and development 

funding in this area in the near- and 

mid-terms. Given the current immature 

status of the development pipeline, a 

single antidote for volatile nerve agents 

would likely not be available for 

acquisition until the long-term 

timeframe. 

Conclusion 

This HHS PHEMCE Implementation 

Plan identifies top priorities for medical 

countermeasure research, development 

and acquisition programs that HHS has 

determined, in collaboration with 

interagency partners, to have the 

greatest potential to improve public 

health emergency preparedness. It is 

anticipated that this plan will be 

reviewed at least biennially to 

encompass potential changes in 

assessments of the threat, consequences 

(particularly with regard to the 

evolution of CONOPs), and maturity of 

the medical countermeasure 

development pipeline. 

The prioritization of medical 

countermeasure programs described in 

this HHS PHEMCE Implementation Plan 

represents the current thinking of HHS 

informed by material threat 

determinations, population threat 

assessments, or the assessments of 

medical and public health 

consequences. DHS is conducting an 

integrated CBRN threat assessment, to 

be completed in June 2008 that will 

further inform the next version of the 

HHS PHEMCE Implementation Plan. 

Additionally, future versions are 

anticipated to incorporate more detailed 

assessments of potential multipliers of 

medical countermeasure requirements, 

based on the potential for enhanced, 

emerging, or advanced biological agents, 

multiple and simultaneous CBRN events 

and other factors informed by scientific 

and threat analysis. As State, local, and 

tribal medical countermeasure delivery 

capabilities and event response 

planning evolve, they will also open 

new flexibilities with respect to the 

types of medical countermeasures that 

can be incorporated into Federal 

planning efforts, and will influence 

HHS assessments of potential medical 

and public health consequences 

following CBRN events. 

The development and acquisition 

strategies to most effectively improve 

preparedness resulted from critical 

evaluation of the status of medical 

countermeasure development pipelines. 

HHS recognizes that developing, 

acquiring, and utilizing medical 

countermeasures to prepare for and 

respond to CBRN events requires 

significant resources and unprecedented 

cooperation among many stakeholders, 

including Federal counterparts outside 

HHS; private industry (domestic and 

international); State, local and tribal 

governments; first responders and 

healthcare workers; academia; and the 

public. HHS will build upon its 2006 

RFI for medical countermeasures against 

CBRN threats, including the technology 

readiness levels (TRLs) defined in that 

RFI, to continue to explore new, more 

efficient ways to reach out to the 

academic and medical countermeasure 

development communities to ensure 

that future versions of the HHS 

PHEMCE Implementation Plan are 

informed by the latest breakthroughs in 

the field. 

In addition, while this HHS PHEMCE 

Implementation Plan focuses on the 

further enhancement of public health 

emergency preparedness, HHS is 

simultaneously evaluating the costs and 

benefits associated with the mid- and 

long-term maintenance of existing and 

projected stockpiles of medical 

countermeasures. HHS anticipates that 

such an evaluation will be detailed in a 

future version of the HHS PHEMCE 

Implementation Plan. 

Finally, Advanced Development 

activities will depend upon 

congressional approval of the 

President’s FY 2008 budget request and 

will increase the chance of 

programmatic success. Through the 

Pandemic and All-Hazards 

Preparedness Act, HHS now has the 

authority to promote innovation, 

increase the potential for success for 

both medical countermeasure 

developers and the Government, and 

invest in medical countermeasure 

advanced development that will carry 

products across the so-called ‘‘Valley of 

Death’’ to meet medical countermeasure 

requirements. It is anticipated that 

future versions of the HHS PHEMCE 

Implementation Plan will more fully 

incorporate implementation of these 

authorities and funding levels that may 

be appropriated in support of the robust 

advanced development programs that 

are critical to mission success. 

The prioritization of medical 

countermeasures to improve public 

health preparedness reflected in this 

HHS PHEMCE Implementation Plan was 

an interagency process led by HHS and 

involving significant collaboration with 

DHS, DOD, VA, and others. The HHS 

PHEMCE Implementation Plan has also 

benefited tremendously from the 

information provided by Stakeholders, 

particularly at the BioShield 

Stakeholders Workshop held in 

September 2006, and from the many 

formal comments received in response 

to the Federal Register notice of the 

draft HHS PHEMCE Strategy. Notice of 

the issuance of this HHS PHEMCE 

Implementation Plan will be posted in 

the Federal Register and HHS welcomes 

comments from stakeholders. 

The HHS PHEMCE Implementation 

Plan will be a feature of the upcoming 

HHS Public Health Emergency Medical 

Countermeasures Enterprise 

Stakeholders Workshop to be held in 

Washington, DC, July 31—August 2, 

2007. HHS is committed to improving 

transparency and continuing to find the 

most appropriate venues to work with 

stakeholders who are likewise 

committed to meeting the goals of this 

critical mission of preparing the nation 

for the adverse health consequences of 

public health emergencies. 

Improving preparedness will be an 

ongoing process as science advances, 

innovations mature, and the threat 

scope changes. HHS resources beyond 

the SRF, when it ends in FY 2013, will 

continue to be strategically invested in 

programs throughout the medical 

countermeasure development and 

acquisition pipeline to achieve this goal. 

It is anticipated that targets for the 

timeframe beyond FY 2013 will be 

articulated with increasing clarity and 

granularity with each successive 

revision of the HHS PHEMCE 

Implementation Plan. 

Finally, to successfully execute the 

program objectives outlined in the HHS 

PHEMCE Implementation Plan for 

Chemical, Biological, Radiological and 

Nuclear Threats, ASPR will strengthen 

and build upon its achievements to 

develop, recruit, and support a worldclass workforce. To realize this goal, 

ASPR will intensify its efforts to attract 


jlentini on PROD1PC65 with NOTICES
20128 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Notices 

and expedite hiring of qualified 

candidates; focus and align training, 

education, and career development; 

recognize staff accomplishments; and 

foster learning and growth with 

improved knowledge management. 

Dated: April 17, 2007. 

Gerald Parker, 

Principal Deputy Assistant Secretary, Office 

of the Assistant Secretary for Preparedness 

and Response, Department of Health and 

Human Services. 

[FR Doc. 07–1983 Filed 4–18–07; 12:17 pm] 

BILLING CODE 4150–37–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–07–0217] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Vital Statistics Training Application, 

OMB No. 0920–0217–ExtensionNational Center for Health Statistics 

(NCHS), Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

In the United States, legal authority 

for the registration of vital events, i.e., 

births, deaths, marriages, divorces, fetal 

deaths, and induced terminations of 

pregnancy, resides individually with the 

States (as well as cities in the case of 

New York City and Washington, DC) 

and Puerto Rico, the Virgin Islands, 

Guam, American Samoa, and the 

Commonwealth of the Northern Mariana 

Islands. These governmental entities are 

the full legal proprietors of vital records 

and the information contained therein. 

As a result of this State authority, the 

collection of registration-based vital 

statistics at the national level, referred 

to as the U.S. National Vital Statistics 

System (NVSS), depends on a 

cooperative relationship between the 

States and the Federal government. This 

data collection, authorized by 42 U.S.C. 

242k, has been carried out by NCHS 

since it was created in 1960. 

NCHS assists in achieving the 

comparability needed for combining 

data from all States into national 

statistics, by conducting a training 

program for State and local vital 

statistics staff to assist in developing 

expertise in all aspects of vital 

registration and vital statistics. The 

training offered under this program 

includes courses for registration staff, 

statisticians, and coding specialists, all 

designed to bring about a high degree of 

uniformity and quality in the data 

provided by the States. This training 

program is authorized by 42 U.S.C. 

242b, section 304(a). In order to offer the 

types of training that would be most 

useful to vital registration staff 

members, NCHS requests information 

from State and local vital registration 

officials about their projected needs for 

training. NCHS also asks individual 

candidates for training to submit an 

application form containing name, 

address, occupation, work experience, 

education, and previous training. These 

data enable NCHS to determine those 

individuals whose needs can best be 

met through the available training 

resources. NCHS is requesting 3 years of 

OMB clearance for this project. There is 

no cost to respondents in providing 

these data other than their time. The 

total estimated annualized burden hours 

are 44. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response (in 

hours) 

State, local, and Territory Registration Officials .......................................................................... 57 1 20/60 

Training applicants ....................................................................................................................... 100 1 15/60 

Dated: April 17, 2007. 

Maryam Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–7648 Filed 4–20–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–07–06AO] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Joan Karr, CDC 

Acting Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Evaluation of an Occupational Safety 

and Health Program for the Small 

Business Wood Pallet Industry, National 

Institute for Occupational Safety and 

Health (NIOSH), Centers for Disease 

Control and Prevention (CDC). 


jlentini on PROD1PC65 with NOTICES