Statement of Organization, Functions, and Delegations of Authority, 14449-14454 [2010-6372]
Download as PDF
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
keeping informed and working together;
(7) FDA conduct of clinical investigator
inspections; (8) meetings with FDA:
why, when, and how; (9) investigator
initiated research; (10) medical device
aspects of clinical research; (11)
working with FDA’s Center for Biologics
Evaluation and Research; and (12) The
inspection is over—what happens next?
What are the possible FDA compliance
actions?
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393) which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The workshop also is consistent
with the Small Business Regulatory
Enforcement Fairness Act of 1996
(Public Law 104–121) as an outreach
activity by Government agencies to
small businesses.
Dated: March 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6579 Filed 3–24–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSKH9S0YB1PROD with NOTICES
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 10296, dated
March 5, 2010) is amended to reflect the
establishment of the Office of the
Associate Director for Policy.
Section C–B, Organization and
Functions, is hereby amended as
follows: Delete in their entirety the title
and functional statements for the CDC
Washington Office (CAQ) and insert the
following:
Office of the Associate Director for
Policy (CAQ). The mission of CDCs
Office of the Associate Director for
Policy (OADP) is to bring about policies
that result in demonstrable
improvements in public health-globally
and at the federal, state, and local levels.
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
In carrying out its mission, OADP: (1)
Provides advice to CDC leadership in
developing agency policy and legislative
strategies; (2) creates and maintains
partnerships to implement policy and
legislative strategies; (3) implements key
policies to improve public health; (4)
ensures the agency’s scientific
credibility, reputation, and needs are
respected and supported by policy
makers and stakeholders.
Office of the Director (CAQ1). (1)
Provides strategic advice to CDC
leadership on overall agency direction
and priorities, and drives CDC towards
actions to reduce leading preventable
causes of morbidity and mortality; (2)
ensures organizational effectiveness in
policy or strategy across the agency; (3)
ensures capacity throughout CDC for
policy and strategy; (4) leads the
development and management of policy
agendas with federal agencies and other
organizations; (5) establishes strategy
and maintains relations with key
organizations and individuals working
on public health policies or legislation.
Office of Prevention through
Healthcare (CAQ 12). (1) Uses policy
tools to gain the maximum preventive
benefit from the clinical system and to
integrate clinical care with community
health interventions; (2) draws upon
expertise and functional roles resident
in other units of the Office of the
Associate Director for Policy as well as
from across CDC to apply that expertise
and functionality to advancing
prevention through healthcare; (3) crafts
a coordinated agency response to
implementing provisions of health
reform legislation once it is enacted.
Policy Research, Analysis, and
Development Office (CAQB). (1)
Identifies and assists CDC leadership in
establishing policy at multiple levels
(federal, state, local, global and in the
private sector); (2) conducts policy
analysis (including regulatory, legal,
economic); (3) develops and implements
strategies (including regulatory, legal,
economic) to deliver on policy
priorities; (4) coordinates agency work
with the healthcare system and other
health-related organizations to advance
CDCs policy agenda within the
healthcare sector; (5) develops expertise
in programs, regulations, and initiatives
of other agencies that may provide
opportunity for health impact; (6) builds
relations with government agencies and
other organizations to advance policy
agendas, with a special emphasis on
state and local agencies; (7) monitors
and evaluates impact of policy
implementation priorities; (8) identifies
and assesses policy best practices and
helps diffuse and replicate those
practices; (9) leads the strengthening
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
14449
and development of policy capacity and
talent within CDC, as well as within the
larger public health community; (10)
leads the development and
implementation of CDCs health policy
research agenda; (11) ensures CDC
operates in an integrated, consistent
manner in policy-related activities; (12)
leverages relationships with think tanks,
policy consultancies, and academic
institutions; (13) manages selected
partner cooperative agreements and
contracts that focus on policy; and (14)
develops an agency-wide strategy
related to advancing policy for partner
relations that are managed elsewhere in
CDC.
CDC Washington Office (CAQC). (1)
Directs and manages CDC interactions
with Congress; (2) leads the
development and oversees the execution
of appropriations strategies; (3) develops
and executes legislative strategies; (4)
builds Congressional relations; (5) tracks
and analyzes legislation; (6) develops
strategy and leads response efforts for
Congressional oversight; (7) builds
relations with government agencies and
other organizations to advance policy
agendas, with an emphasis on federal
agencies; (8) protects and advances the
agency’s reputation, scientific
credibility, and interests; (9) informs
CDC leadership of current developments
and provides insight into the
Washington policy environment; (10)
coordinates District of Columbia-area
assignees and helps maximize their
impact in supporting the agency’s
strategies and priorities.
Dated: March 11, 2010.
William P. Nichols,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–6375 Filed 3–24–10; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 10296, dated
March 5, 2010) is amended to reflect the
reorganization of the Office of Public
Health Preparedness and Response,
E:\FR\FM\25MRN1.SGM
25MRN1
mstockstill on DSKH9S0YB1PROD with NOTICES
14450
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
Office of the Director, Centers for
Disease Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows: Delete in its entirety the title
and functional statements for the Office
of Public Health Preparedness and
Response (CG) and insert the following:
Office of Public Health Preparedness
and Response (CG). The mission of the
Office of Public Health Preparedness
and Response (OPHPR) is to safeguard
health and save lives by providing a
platform for public health preparedness
and emergency response. To carry out
its mission, OPHPR: (1) Fosters
collaborations, partnerships, integration,
and resource leveraging to increase the
Centers for Disease Control and
Prevention’s (CDC) health impact and
achieve population health goals; (2)
provides strategic direction to support
CDC’s public health preparedness and
response efforts; (3) manages CDC-wide
preparedness and emergency response
programs; (4) maintains CDC’s platforms
for emergency response operations—
including the Emergency Operations
Center (EOC), the Strategic National
Stockpile (SNS), the Public Health
Emergency Preparedness Cooperative
Agreement Program and the Select
Agent and Toxins regulatory program;
(5) communicates the mission, functions
and activities of public health
preparedness and emergency response
to internal and external stakeholders; (6)
delivers critical medical assets to the
site of a national emergency; (7)
provides program support, technical
assistance, guidance and fiscal oversight
to State, local, Tribal and territorial
public health department grantees; (8)
provides CDC’s core incident
management structure to coordinate and
execute preparedness and response
activities; (9) regulates the possession,
use and transfer of select agents and
toxins and the importation of etiological
agents, hosts, and vectors of human
disease to protect public health in the
United States; and (10) provides the
centralized management and
coordination of national scenario
capabilities planning and exercising of
these plans for CDC.
Office of the Director (CGA). (1)
Manages, directs, and coordinates the
activities of the office; (2) coordinates
the development and implementation of
OPHPR strategy in support of CDC’s
preparedness and response goals and
priorities; (3) develops CDC policy and
legislative strategy, as related to public
health preparedness and emergency
response; (4) serves as spokesperson for
CDC policies and strategies regarding
public health preparedness and
response; (5) establishes, implements
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
and communicates a comprehensive
and integrated framework of
preparedness and response performance
goals and associated outcome, output,
and process measures; (6) identifies
needs and resources for new initiatives
and assigns responsibilities for their
development; (7) assures CDC
preparedness and response plans align
with National and Federal preparedness
and response policy, doctrine, and
plans; (8) develops performance profiles
to monitor, report, and improve public
health preparedness and response; (9)
coordinates and implements CDC’s
preparedness and response learning
strategy in support of OPHPR goals and
priorities; (10) develops, implements,
and evaluates workforce development
programs for internal CDC responders
and external audiences with public
health preparedness and response
responsibilities; (11) establishes and
implements a communications strategy
in support of OPHPR overarching goals
and priorities; (12) develops budget
formulation documents for OPHPR to
support CDC’s Public Health
Preparedness and Response (PHPR)
budget; (13) evaluates programmatic
performance of all funded PHPR
activities; (14) provides the OPHPR OD
and Divisions with centralized business
and program services; (15) plans,
coordinates, and manages all aspects of
program business services including
human and fiscal resources,
procurement, cooperative agreements,
space and all administrative services;
(16) devises information technology
practices and procedures, and provides
direction, planning and evaluation for
information technology systems and
services, information security, and
information resources for OPHPR; (17)
provides scientific oversight, advice,
guidance and leadership for the
development of OPHPR science and
public health; (18) coordinates the
development of a research agenda for
emergency preparedness and response
priorities; (19) coordinates and manages
the activities of the Board of Scientific
Counselors for OPHPR; (20) provides
consultation, support and service to
OPHPR divisions for planning,
evaluation, policy, education and
training, business and fiscal
management, information resource, and
workforce planning services; and (21)
oversees quality assurance and quality
control of stockpile assets.
Division of State and Local Readiness
(CGC). The Division of State and Local
Readiness provides program support,
technical assistance, guidance and fiscal
oversight to State, local, Tribal and
territorial public health department
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
grantees for the development,
monitoring and evaluation of public
health capabilities, plans, infrastructure
and systems to prepare for and respond
to terrorism, outbreaks of disease,
natural disasters and other public health
emergencies.
Office of the Director (CGC1). (1)
Provides national leadership and
guidance that supports and advances
the work of State, local, Tribal and
territorial public health emergency
preparedness programs; (2) coordinates
the development of scientific guidelines
and standards for programmatic
materials within the division to provide
technical assistance and program
planning at the State, local, Tribal, and
territorial level; (3) represents the
interests and needs of the State, local,
Tribal, and territorial interests on State
and local preparedness; (4) develops
and ensures effective partnerships with
national stakeholders and preparedness
partners; and (5) provides oversight and
management of division contracts,
technical assistance plan development,
training needs, response activities,
grantee awards and fiscal
accountability, and research agenda
development and compliance.
Program Services Branch (CGCB). (1)
Provides consultation to State,
territorial, Tribal and local health
departments in the management and
operation of activities to support public
health preparedness, response and
recovery; (2) facilitates partnerships
between public health preparedness
programs at Federal, State, and local
levels to ensure their consistency,
sharing promising practices, and
integration; (3) engages and supports
other National Centers across CDC to
ensure high quality technical assistance
is available to the grantees on
preparedness capabilities; (4) supervises
Federal field staff providing technical
assistance to State and local public
health preparedness programs; (5)
provides oversight to partnership
organization cooperative agreements;
and (6) monitors activities of
cooperative agreements and grants of
partners and State, local, Tribal and
territorial organizations to assure
program objectives and key performance
indicators are achieved.
Outcome Monitoring and Evaluation
Branch (CGCC). (1) Collaborates and
consults with CDC staff, other Public
Health Service agencies, State and local
health departments, and other groups
and organizations involved in
preparedness activities to develop
performance measures; (2) summarizes
and synthesizes the preparedness
research literature; identifies promising
program practices and translates
E:\FR\FM\25MRN1.SGM
25MRN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
findings into public health preparedness
program guidance, technical assistance,
and evaluation practices to be shared
and implemented at the State and local
level; (3) conducts evaluation research
activities to evaluate the effectiveness
and impact of preparedness programs;
(4) provides guidance, training and
technical assistance to grantees on the
collection and use of program
evaluation data; (5) serves as a resource
for building evaluation capability with
CDC staff, partners and stakeholders; (6)
collects, analyzes, interprets and applies
information to identify gaps in State and
local public health preparedness; (7)
monitors State and local achievement of
public health preparedness performance
measures; and (8) develops and
maintains a real-time management
information system to monitor projects
funded by the State and Local
Preparedness Cooperative Agreement
requirements.
Division of Strategic National
Stockpile (CGE). The Division of
Strategic National Stockpile (DSNS)
delivers critical medical assets to the
site of a national emergency. The SNS
is a national repository of antibiotics,
chemical antidotes, vaccines, antitoxins,
life-support medications, intravenous
administration and airway maintenance
supplies, and medical/surgical items. It
is designed to re-supply State and local
public health agencies in the event of a
catastrophic health event anywhere, at
anytime within the U.S. The DSNS
ensures the availability and rapid
deployment of the SNS and supports,
guides, and advises on efforts by State
and local governments to effectively
manage and use SNS assets that may be
deployed. The DSNS stands ready for
immediate deployment to any U.S.
location in the event of a catastrophic
health event.
Office of the Director (CGE1). (1)
Conducts the executive planning and
management of the division; (2) plans
strategies and methods for educating the
public health and emergency response
communities about the SNS and its
effective use; (3) represents the SNS in
State, local, and Federally sponsored
exercises to test community response to
a catastrophic health event; (4) directs
and monitors a comprehensive strategy
for managing and executing the critical
systems in operating a successful
commercial good manufacturing
practice compliance program; (5)
provides medical, pharmaceutical, and
scientific oversight of the SNS
formulary; (6) partners with other
governmental agencies, public health
organizations, and commercial entities
with interest and involvement in SNS
activities and information; and (7)
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
coordinates the Stockpile Configuration
Management Board that is responsible
for reviewing, reconciling, and adjusting
SNS package and kit design and
contents to maintain consistency with
medical, scientific, resource, and end
user requirements.
Logistics Branch (CGEB). (1) Defines
operational requirements once the SNS
formulary is established by the Office of
the Director and HHS Public Health
Emergency Countermeasures Enterprise
(PHEMCE); (2) manages the
procurement of medical materiel to
meet those requirements through the
CDC Federal procurement system; (3)
manages and tracks the expenditure of
DSNS funds for the procurement,
storage, and transport of medical
materiel assets; (4) supervises the
storage of the SNS 12-hour Push
Packages; (5) manages the development
and oversight of contracts for Stockpile
Managed Inventory (SMI) and Vendor
Managed Inventory (VMI) with
commercial manufacturers and
distributors of medical materiel; (6)
acquires facilities and provides the
infrastructure for storage of SNS assets;
(7) manages the rotation of dated
products in the 12-hour Push Packages,
in SMI, and in VMI; (8) coordinates the
physical security and safety of SNS
assets with all storage sites through the
Office of Security and Emergency
Preparedness; (9) in full exercises or
upon a Federal deployment of the SNS,
provides logistics expertise for the
Technical Advisory Response Unit
(TARU) or other deployable/deployed
teams that will accompany the SNS to
the scene of the chemical/nerve agent or
bio-terrorism event as well as for the
team staffing the DSNS Team Room in
the CDC Emergency Operations Center;
(10) coordinates the recovery of unused
SNS assets that will be returned to the
SNS inventory which were deployed in
an actual chemical/nerve agent or bioterrorism event, including the recovery
of SNS air cargo containers; (11)
maintains the capacity to transport any
and all SNS assets by overseeing
contractual arrangements with
commercial cargo carrier partners; (12)
stores and maintains vaccines,
therapeutic blood products, and
antitoxins in selected repositories
designated for managing and shipping
these and other special medical
countermeasures; (13) manages the
forward deployment and sustainment of
CHEMPACK chemical countermeasures
in State-determined locations
throughout the U.S. in conjunction with
the other functional areas of DSNS; (14)
manages the routine maintenance of
SNS equipment; (15) manages the Shelf
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
14451
Life Extension Program in coordination
with the Food and Drug Administration
and the Department of Defense; (16)
serves as a storage and distribution
source to the Department of Defense for
biologic products; (17) provides
continuing development of the Federal
Medical Stations (FMS) program to
deploy a surge capability throughout the
Nation; and (18) coordinates quality
assurance and quality control visits of
stockpile assets.
Program Preparedness Branch
(CGEC). (1) Coordinates the
development, refinement, and
dissemination of guidance for CDCfunded public health project areas to
plan for and build the infrastructure and
systems necessary to manage and use
deployed SNS assets; (2) analyzes the
overall developmental needs of
personnel in State/local Public Health
Preparedness Programs and creates,
implements, and manages technical
assistance and other developmental
activities designed to meet those needs;
(3) coordinates DSNS supported
exercises with the Response Branch and
project area Preparedness Plans; (4)
collaborates with the Division of State
and Local Readiness (DSLR) by
providing support for their
responsibilities as project officers
relative to the SNS components of the
CDC Public Health and Emergency
Preparedness cooperative agreement
and supplemental awards; (5) reviews
response plans of each of the CDC
funded project areas and all Cities
Readiness Initiative (CRI) participants to
effectively manage and use deployed
SNS assets; (6) functions as the primary
agent for the CR1, providing assistance
to State and local governments and
public health agencies in engaging
communities of major metropolitan
areas to prepare for effective responses
to large scale bioterrorist events by
dispensing antibiotics and other
medical supplies to their entire
populations, if necessary, within 48
hours of the decision to do so; (7) plans,
designs and prepares SNS related
communications and select educational
materials support of State/local SNS
Preparedness Programs; (8) provides
health communications guidance and
products before, during, and after an
event to assist State/local SNS
Preparedness Program personnel and
other public health officials in dealing
with the public; (9) serves as the DSNS
point of contact for collaboration with
various Federal agencies and
nongovernmental organizations (e.g.,
ASTHO, NACCHO) on programmatic
initiatives and issues affecting State/
local SNS preparedness; (10)
E:\FR\FM\25MRN1.SGM
25MRN1
mstockstill on DSKH9S0YB1PROD with NOTICES
14452
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
collaborates with the DSNS Response
and Logistics Branches on special
projects to ensure smooth
implementation and successful ongoing
performance; and (11) during exercises
or upon a Federal deployment of the
SNS assets, provides Project Area
liaison expertise for the TARU and for
the DSNS Team Room of the CDC EOC.
Planning and Analysis Branch
(CGED). (1) Supervises the design,
implementation, and day-to-day
execution of processes and systems to
improve cost analysis, cost evaluation,
planning and financial management for
DSNS; (2) manages the development of
program policies and procedures as well
as performing periodic analysis of
existing policies to assess compliance
and requirements; (3) coordinates in
collaboration with the other branches
the development, testing,
implementation, training, and selected
operations of DSNS’s unique
information management systems and
technology; (4) monitors and manages
reporting of DSNS performance
measures; (5) provides project
management for new missions and
initiatives within the division;
(6) provides leadership in issue and risk
management, business transformation,
and change management; (7) provides
support to the Veterans Administration
(VA) contracting office by acting as a
primary liaison between DSNS and the
VA National Acquisition Center;
(8) maintains contract management
responsibility within DSNS; and
(9) develops, in collaboration with
various contractors and universities,
models for use by Project Areas in
implementing SNS elements of their
Public Health Preparedness Programs.
Response Branch (CGEE). (1) Plans
and manages response operations of the
DSNS during day-to-day operations and
activation in response to emergencies
and exercises; (2) supervises the
preparation and readiness of all on site
and off site response coordination
facilities to maintain each in a ready
state, including oversight of all related
equipment, plans, and procedures;
(3) manages the development,
coordination, and maintenance of DSNS
response and deployment plans; (4)
supervises the staffing, preparation, and
readiness of TARU and Team Room staff
to respond to emergencies (5) manages
the planning, coordination, and conduct
of internal and partner training;
(6) manages the planning, coordination,
and conduct of internal DSNS exercises
and participation in Federal, State, and
local exercises; (7) manages the DSNS
Corrective Action Program for exercises
and responses to actual emergencies;
(8) manages personnel transport
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
capability through overseeing and
exercising contractual arrangements
with the contract air service partner; (9)
manages DSNS personal and program
response communications devices and
systems; (10) in full exercises or upon
a Federal deployment of the SNS,
provides staff for the SNS Team Room
in the CDC EOC as well as for the TARU
that will accompany the SNS assets;
(11) participates in periodic Quality
Assurance/Quality Control visits to SNS
storage sites coordinated by the
Logistics Branch; and (12) oversees the
day-to-day operation and administration
of DSNS’ Stockpile Resource Planning
(SRP) solution to ensure real time access
to mission critical data and provide 24/
7/365 redundant network infrastructure
in coordination with ITSO.
Division of Select Agents and Toxins
(CGF). The Division of Select Agents
and Toxins (DSAT): (1) Conducts
registration of entities with the United
States (academic, military, commercial,
private, Federal and non-Federal
government) that use, possess and
transfer select agents and toxins;
(2) establishes and maintains a national
database of all entities that possess
select agents; (3) inspects entities to
ensure that bio-safety and biosecurity
regulations and national standards are
met; (4) approves all select agent or
toxin transfers; (5) receives and
investigates reports of theft, loss, or
release of a select agent or toxin;
(6) partners with other government
agencies, public health organizations,
and registered entities to ensure
compliance with the Select Agent
Regulations; (7) issues permits for the
importation of etiologic agents and hosts
or vectors of human disease; and
(8) provides guidelines and training to
regulated community on requirements.
Office of the Director (CGF1).
(1) Manages operations; (2) provides
scientific leadership and consultation;
(3) coordinates and supports the CDC
Intra-governmental Select Agent and
Toxin Technical Advisory Committee
and the development and
implementation of training programs for
select agent inspectors; (4) provides
oversight over the execution of
regulatory rulemaking activities
associated with the DSAT Select Agent
and Import Permit Programs;
(5) provides leadership and guidance in
the area of biosafety; (6) manages and
responds to reports of potential theft,
loss, or release of select agents;
(7) coordinates special inspections and
other oversight or incidence response
activities involving highly complex
entities, including facilities that house
BSL–4 laboratories; and (8) provides
input to divisional training programs
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
and outreach activities for the regulated
community.
Operations Branch (CGFB).
(1) Conducts on-site inspections of
entities that use, possess and transfer
select agents and toxins; (2) schedules
and coordinates on-site inspections;
(3) reviews entity applications,
amendments and other entity
documentation; (4) prepares reports of
on-site inspections and conducts followup on noted deficiencies; (5) maintains
entity files to ensure that the Program
has the most current and accurate
information; (6) communicates with
entities Responsible Officials on any
issues related to applications,
amendments, inspections, and other
entity documentation; (7) coordinates
all activities related to operations with
the records management group; and
(8) serves as a liaison for the USDA,
APHIS Select Agent Program.
Program Management and Operations
Branch (CGFC). (1) Provides oversight
and leadership over all business
activities for the Division; (2) manages
all space and facilities issues for DSAT;
(3) develops DSAT budget planning and
formulation; (4) provides leadership for
DSAT management team and oversight
on budget execution activities;
(5) coordinates strategic planning/
operations; (6) provides oversight on all
contract and grant formulation, award,
and administration; (7) manages
division IT development, operations,
and compliance; (8) manages all
negotiation and/or oversight of Interand Intra-Agency Agreements,
Memorandums of Agreements, and
Service Level Agreement between the
division and various entities/
organizations; (9) provides property
management oversight, assignment,
administration, and accountability; and
(10) interacts with the appropriate CDC
and OPHPR business and operations
offices.
Program Services Branch (CGFD).
(1) Processes requests for transfer of
select agents and toxins; (2) processes
permit applications to import etiological
agents, hosts, and vectors of human
disease (not limited to select agents)
into the United States; (3) evaluates
entities’ security plans and practices
and submits reports to entities’ file
managers; (4) manages the security risk
assessment (SRA) process to ensure that
no restricted persons have access to
select agents and toxins; (5) provides
consultation on DSAT security policies
and practices; (6) processes reports of
select agents or toxins identified
through diagnosis, verification, or
proficiency testing; (7) reviews noncompliance issues, assists with evidence
gathering, makes recommendations
E:\FR\FM\25MRN1.SGM
25MRN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
concerning non-compliance issues,
drafts compliance letters and tracks
non-compliance issues; (8) assists in the
writing and tracking of Federal Register
notices and other legal documents for
the Division; (9) serves as liaison for
DSAT for the HHS Office of Inspector
General and Federal Bureau of
Investigation (FBI); (10) processes
requests for exemptions for
investigational products that are, bear,
or contain select agents or toxins, or to
provide a response to a public health
emergency; (11) works with the FBI and
the DSAT ADB on criminal
investigations of the theft or loss of
select agents or toxins; (12) coordinates
all emergency notification functions;
and (13) manages the Program’s sharing
of select agent information with the
States.
Division of Emergency Operations
(CGG). The Division of Emergency
Operations (DEO) utilizing the Incident
Command System (ICS) structure: (1)
Staffs and utilizes the EOC to assist
Centers and Offices to manage the
utilization of resources to support
public health routine and emergency
situations, domestically and
internationally; (2) serves as the primary
point of contact under the Homeland
Security Presidential Directive (HSPD–
5) Emergency Support Function #8
(Public Health and Medical Services);
(3) maintains and operates the CDC
National-level EOC which serves as the
focal point for collaboration and
information sharing throughout CDC,
24/7/365; (4) coordinates with all CDC’s
Centers/Institute/Offices with planning,
training, exercising, reporting and
coordinating logistical support during
pre-response activities and during
responses; and (5) apprises CDC
leadership and outside agencies of CDC
response activities and subject-matter
expert situational reports.
Office of the Director (CGG1). (1)
Manages the day-to-day operations of
the division and provides leadership,
resource prioritization, and guidance
during public health responses; (2)
coordinates the daily management of
resources for the division including
budget, personnel, and acquisitions in
coordination with OPHPR Office of
Management Services; (3) coordinates
technology improvements and
information support requirements for
the division and EOC; (4) provides
strategic planning to develop
performance management goals,
objectives, and measurements for the
division; (5) manages DEO’s scientific
activities within the division and across
CDC; (6) improves the timeliness and
accuracy of public health information
gathering, analysis, and sharing through
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
knowledge management and situational
awareness in an effort to maximize the
speed and accuracy of decision making;
and (7) provides a 24/7/365 situational
awareness capability to maximize
accurate information flow.
Emergency and Risk Communications
Branch (CGGB). (1) Identifies and
implements strategies for translation
and delivery of CDC’s emergency risk
communication messages and
information to key targeted audiences
for maximum health impact; (2)
coordinates and integrates cross-agency
communication activities to fulfill
emergency risk communication
strategies to respond to public health
emergencies; (3) provides leadership
and core staffing for the Joint
Information Center in CDC’s EOC during
public health emergencies; (4) serves as
CDC’s primary communication liaison
during public health emergencies to
other responding agencies to ensure
communication coordination with local,
State, Federal, and international
partners; (5) monitors, evaluates, and
refines risk and emergency
communication messages and channels
messages based on feedback,
communication research, and best
practices; (6) evaluates the reach and
effectiveness of CDC’s risk and
emergency communication messages
and products; (7) ensures that the
content of CDC’s emergency risk
communication messages are accessible
(available, understandable, actionable)
and disseminated to the public and
target audiences; (8) develops and
manages selected channels to deliver
national emergency and terrorismrelated messages; (9) coordinates the
distribution of emergency risk
communication messages and
information through additional nonCDC channels and engagement
mechanisms including news media,
social media networks, and partner
outreach; (10) provides an integrated
marketing perspective to risk emergency
communication; (11) employs a
systematic process for assessing public
awareness, knowledge, attitudes,
reactions, and behaviors related to
urgent health threats, CDC’s emergency
risk communication messages, and CDC
programs; (12) uses the results of
assessment process as input into agency
decision making and communication
planning; (13) provides technical
assistance in emergency risk
communication and operations to
internal and external partners and
supports emergency risk
communication capacity building; and
(14) sponsors/initiates original research
related to emergency risk
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
14453
communication messages on customer,
stakeholder, and partner needs,
interests, and reactions.
Logistics Support Branch (CGGC). (1)
Ensures policies, plans and procedures
are in place to provide logistical,
administrative, and crisis movement
support to CDC deployed personnel and
response assets, including
communications; (2) provides
deployment support for CDC personnel
to provide on-site logistical and
administrative support to CDC response
assets, including communications; (3)
coordinates with external logistical and
transportation offices during
emergencies; (4) advises the DEO
Director regarding logistics and
transportation activities and provides
logistics and transportation planning
support for operations plan
development and during emergency
responses; (5) manages property
accountability; procures, maintains,
manages, tracks, and coordinates
movement of supplies, services, and
equipment for CDC including specimens
and hazardous cargo shipments in
response to emergency deployment
operations; (6) coordinates with the CDC
Office of Health and Safety (OHS) and
other CDC entities for all CDC medical
evacuation missions involving the
movement of suspected infectious and
contagious patients; (7) coordinates offsite communications and reach-back
capabilities, to include real time
exchange of information for deployed
personnel and teams; and (8) manages
the operation and employment of the
CDC aircraft.
Operations Branch (CGGD). (1)
Maintains a 24/7/365 capability to
respond to emergencies and coordinate
emergency management processes and
protocols across CDC; (2) monitors
national and international public health
emergencies and maintains a common
operating picture for CDC leadership
and HHS/ASPR; (3) serves as the central
point of contact between CDC and
public health agencies nationally and
internationally for emergency
management and response; (4) supports
the myriad of sophisticated audiovisual,
administrative, and communication
functions, including equipment,
necessary to maintain a state-of-the-art
national emergency operations center;
(5) identifies the requirements to fully
staff all of the functional roles of the
IMS to meet a 24/7/365, all hazard,
public health emergency, including
identifying personnel across CDC to
staff operations functional roles; (6)
conducts coordination, planning, and
training necessary to implement
Continuity of Operations (COOP); (7)
coordinates movement/deployment of
E:\FR\FM\25MRN1.SGM
25MRN1
mstockstill on DSKH9S0YB1PROD with NOTICES
14454
Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices
resourced requirements with logistics;
(8) ensures the agency deployment
coordination plan represents a
comprehensive strategy to identify,
recruit, prepare, and maintain a
workforce capable of responding rapidly
and efficiently to all events requiring
CDC public health response leadership,
guidance, or support; (9) maintains and
coordinates deployment activities
supporting deployer health and safety
requirements; and (10) monitors, tracks,
and assists HHS/Office of Force
Readiness and Deployment (OFRD)
deployments which utilize
Commissioned Corps officers stationed
at CDC.
Plans, Training, Exercise and
Evaluation Branch (CGGE). (1) Develops
CDC emergency operations plans, eventspecific incident annexes, and national
special security event plans, and
collaborates across CDC to facilitate
development of internal standard
operating procedures to support these
plans; (2) acts as planning liaison to
other organizations and reviews,
analyzes and provides comments on
Federal and national plans or inquires;
(3) provides policy oversight and
coordinates the incorporation of
national policy into CDC operations
plans; (4) represents the agency
regarding operational planning and
facilitates or participates in planningfocused work groups; (5) manages the
CDC exercise and incident response
evaluation program; (6) coordinates
training and exercise programs and
provides feedback and
recommendations for After Action
Reports for activities conducted at the
CDC level; (7) collaborates with SMEs
across CDC and external partners to
facilitate evaluation of training,
planning, and exercises to improve
public health preparedness; (8) develops
and coordinates Corrective Action Plans
and tracks Improvement Plans; (9)
coordinates Improvement Plans with
CDC SMEs; (10) designs and delivers
up-to-date CDC and preparation for
exercises in emergency response
training to prepare staff for emergency
situations; (11) tracks CDC responder
and staff certifications; (12) ensures that
Division training programs support
Agency goals; (13) manages exercises to
test the readiness of the CDC IMS and
ensures it supports the National
Planning Scenarios; (14) coordinates
and manages CDC’s participation in
pertinent external all-hazards exercises;
(15) serves as the Chairperson of the
CDCs Exercise Steering Committee and
manages the CDC’s internal exercise
program in collaboration with subject
matter experts across CDC; and (16)
VerDate Nov<24>2008
16:42 Mar 24, 2010
Jkt 220001
facilitates the involvement of States and
other response partners in CDC
exercises.
Dated: March 11, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–6372 Filed 3–24–10; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2010–0025]
National Protection and Programs
Directorate; National Infrastructure
Advisory Council
National Protection and
Programs Directorate, DHS.
ACTION: Committee Management; Notice
of Federal Advisory Council Meeting.
AGENCY:
SUMMARY: The National Infrastructure
Advisory Council (NIAC) will meet on
Tuesday, April 13, 2010, at the National
Press Club’s Ballroom, 529 14th Street,
NW., Washington, DC 20045.
DATES: The National Infrastructure
Advisory Council will meet Tuesday,
April 13, 2010 from 1:30 p.m. to 4:30
p.m. The meeting may close early if the
committee has completed its business.
For additional information, please
consult the NIAC Web site, https://
www.dhs.gov/niac, or contact the NIAC
Secretariat by phone at 703–235–2888
or by e-mail at NIAC@dhs.gov.
ADDRESSES: The meeting will be held at
the National Press Club’s Ballroom, 529
14th Street, NW., Washington, DC
20045. While we will be unable to
accommodate oral comments from the
public, written comments may be sent
to Nancy J. Wong, Department of
Homeland Security, National Protection
and Programs Directorate, 245 Murray
Lane, SW., Mail Stop 0607, Arlington,
VA 20598–0607. Written comments
should reach the contact person listed
no later than March 30, 2010. Comments
must be identified by DHS–2010–0025
and may be submitted by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: NIAC@dhs.gov. Include the
docket number in the subject line of the
message.
• Fax: 703–603–5098.
• Mail: Nancy J. Wong, Department of
Homeland Security, National Protection
and Programs Directorate, 245 Murray
Lane, SW., Mail Stop 0607, Arlington,
VA 20598–0607.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at https://www.regulations.gov,
including any personal information
provided.
Docket: For access to the docket to
read background documents or
comments received by the NIAC, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Nancy J. Wong, National Protection and
Programs Directorate, 245 Murray Lane,
SW., Mail Stop 0607, Arlington, VA,
20598–0607; telephone 703–235–2888.
Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C. App.
(Pub. L. 92–463). The NIAC shall
provide the President through the
Secretary of Homeland Security with
advice on the security of the critical
infrastructure sectors and their
information systems.
The NIAC will meet to address issues
relevant to the protection of critical
infrastructure as directed by the
President. The April 13, 2010, meeting
will receive updates on the progress of
two National Infrastructure Advisory
Council working groups.
The Meeting Agenda is as Follows:
SUPPLEMENTARY INFORMATION:
I. Opening of Meeting
II. Roll Call of Members
III. Opening Remarks and Introductions
IV. Approval of January 2010 Minutes
V. Working Group Status: A Framework for
Establishing Critical Infrastructure
Resilience Goals
VI. Working Group Status: Optimization of
Resources for Mitigating Infrastructure
Disruptions
VII. New Business
VIII. Closing Remarks
IX. Adjournment
Procedural
While this meeting is open to the
public, participation in the National
Infrastructure Advisory Council
deliberations is limited to committee
members, Department of Homeland
Security officials, and persons invited to
attend the meeting for special
presentations.
Information on Services for Individuals
With Disabilities
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meeting, contact the NIAC Secretariat at
703–235–2888 as soon as possible.
E:\FR\FM\25MRN1.SGM
25MRN1
Agencies
[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Notices]
[Pages 14449-14454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6372]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Statement of Organization, Functions, and Delegations of
Authority
Part C (Centers for Disease Control and Prevention) of the
Statement of Organization, Functions, and Delegations of Authority of
the Department of Health and Human Services (45 FR 67772-76, dated
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as
amended most recently at 75 FR 10296, dated March 5, 2010) is amended
to reflect the reorganization of the Office of Public Health
Preparedness and Response,
[[Page 14450]]
Office of the Director, Centers for Disease Control and Prevention.
Section C-B, Organization and Functions, is hereby amended as
follows: Delete in its entirety the title and functional statements for
the Office of Public Health Preparedness and Response (CG) and insert
the following:
Office of Public Health Preparedness and Response (CG). The mission
of the Office of Public Health Preparedness and Response (OPHPR) is to
safeguard health and save lives by providing a platform for public
health preparedness and emergency response. To carry out its mission,
OPHPR: (1) Fosters collaborations, partnerships, integration, and
resource leveraging to increase the Centers for Disease Control and
Prevention's (CDC) health impact and achieve population health goals;
(2) provides strategic direction to support CDC's public health
preparedness and response efforts; (3) manages CDC-wide preparedness
and emergency response programs; (4) maintains CDC's platforms for
emergency response operations--including the Emergency Operations
Center (EOC), the Strategic National Stockpile (SNS), the Public Health
Emergency Preparedness Cooperative Agreement Program and the Select
Agent and Toxins regulatory program; (5) communicates the mission,
functions and activities of public health preparedness and emergency
response to internal and external stakeholders; (6) delivers critical
medical assets to the site of a national emergency; (7) provides
program support, technical assistance, guidance and fiscal oversight to
State, local, Tribal and territorial public health department grantees;
(8) provides CDC's core incident management structure to coordinate and
execute preparedness and response activities; (9) regulates the
possession, use and transfer of select agents and toxins and the
importation of etiological agents, hosts, and vectors of human disease
to protect public health in the United States; and (10) provides the
centralized management and coordination of national scenario
capabilities planning and exercising of these plans for CDC.
Office of the Director (CGA). (1) Manages, directs, and coordinates
the activities of the office; (2) coordinates the development and
implementation of OPHPR strategy in support of CDC's preparedness and
response goals and priorities; (3) develops CDC policy and legislative
strategy, as related to public health preparedness and emergency
response; (4) serves as spokesperson for CDC policies and strategies
regarding public health preparedness and response; (5) establishes,
implements and communicates a comprehensive and integrated framework of
preparedness and response performance goals and associated outcome,
output, and process measures; (6) identifies needs and resources for
new initiatives and assigns responsibilities for their development; (7)
assures CDC preparedness and response plans align with National and
Federal preparedness and response policy, doctrine, and plans; (8)
develops performance profiles to monitor, report, and improve public
health preparedness and response; (9) coordinates and implements CDC's
preparedness and response learning strategy in support of OPHPR goals
and priorities; (10) develops, implements, and evaluates workforce
development programs for internal CDC responders and external audiences
with public health preparedness and response responsibilities; (11)
establishes and implements a communications strategy in support of
OPHPR overarching goals and priorities; (12) develops budget
formulation documents for OPHPR to support CDC's Public Health
Preparedness and Response (PHPR) budget; (13) evaluates programmatic
performance of all funded PHPR activities; (14) provides the OPHPR OD
and Divisions with centralized business and program services; (15)
plans, coordinates, and manages all aspects of program business
services including human and fiscal resources, procurement, cooperative
agreements, space and all administrative services; (16) devises
information technology practices and procedures, and provides
direction, planning and evaluation for information technology systems
and services, information security, and information resources for
OPHPR; (17) provides scientific oversight, advice, guidance and
leadership for the development of OPHPR science and public health; (18)
coordinates the development of a research agenda for emergency
preparedness and response priorities; (19) coordinates and manages the
activities of the Board of Scientific Counselors for OPHPR; (20)
provides consultation, support and service to OPHPR divisions for
planning, evaluation, policy, education and training, business and
fiscal management, information resource, and workforce planning
services; and (21) oversees quality assurance and quality control of
stockpile assets.
Division of State and Local Readiness (CGC). The Division of State
and Local Readiness provides program support, technical assistance,
guidance and fiscal oversight to State, local, Tribal and territorial
public health department grantees for the development, monitoring and
evaluation of public health capabilities, plans, infrastructure and
systems to prepare for and respond to terrorism, outbreaks of disease,
natural disasters and other public health emergencies.
Office of the Director (CGC1). (1) Provides national leadership and
guidance that supports and advances the work of State, local, Tribal
and territorial public health emergency preparedness programs; (2)
coordinates the development of scientific guidelines and standards for
programmatic materials within the division to provide technical
assistance and program planning at the State, local, Tribal, and
territorial level; (3) represents the interests and needs of the State,
local, Tribal, and territorial interests on State and local
preparedness; (4) develops and ensures effective partnerships with
national stakeholders and preparedness partners; and (5) provides
oversight and management of division contracts, technical assistance
plan development, training needs, response activities, grantee awards
and fiscal accountability, and research agenda development and
compliance.
Program Services Branch (CGCB). (1) Provides consultation to State,
territorial, Tribal and local health departments in the management and
operation of activities to support public health preparedness, response
and recovery; (2) facilitates partnerships between public health
preparedness programs at Federal, State, and local levels to ensure
their consistency, sharing promising practices, and integration; (3)
engages and supports other National Centers across CDC to ensure high
quality technical assistance is available to the grantees on
preparedness capabilities; (4) supervises Federal field staff providing
technical assistance to State and local public health preparedness
programs; (5) provides oversight to partnership organization
cooperative agreements; and (6) monitors activities of cooperative
agreements and grants of partners and State, local, Tribal and
territorial organizations to assure program objectives and key
performance indicators are achieved.
Outcome Monitoring and Evaluation Branch (CGCC). (1) Collaborates
and consults with CDC staff, other Public Health Service agencies,
State and local health departments, and other groups and organizations
involved in preparedness activities to develop performance measures;
(2) summarizes and synthesizes the preparedness research literature;
identifies promising program practices and translates
[[Page 14451]]
findings into public health preparedness program guidance, technical
assistance, and evaluation practices to be shared and implemented at
the State and local level; (3) conducts evaluation research activities
to evaluate the effectiveness and impact of preparedness programs; (4)
provides guidance, training and technical assistance to grantees on the
collection and use of program evaluation data; (5) serves as a resource
for building evaluation capability with CDC staff, partners and
stakeholders; (6) collects, analyzes, interprets and applies
information to identify gaps in State and local public health
preparedness; (7) monitors State and local achievement of public health
preparedness performance measures; and (8) develops and maintains a
real-time management information system to monitor projects funded by
the State and Local Preparedness Cooperative Agreement requirements.
Division of Strategic National Stockpile (CGE). The Division of
Strategic National Stockpile (DSNS) delivers critical medical assets to
the site of a national emergency. The SNS is a national repository of
antibiotics, chemical antidotes, vaccines, antitoxins, life-support
medications, intravenous administration and airway maintenance
supplies, and medical/surgical items. It is designed to re-supply State
and local public health agencies in the event of a catastrophic health
event anywhere, at anytime within the U.S. The DSNS ensures the
availability and rapid deployment of the SNS and supports, guides, and
advises on efforts by State and local governments to effectively manage
and use SNS assets that may be deployed. The DSNS stands ready for
immediate deployment to any U.S. location in the event of a
catastrophic health event.
Office of the Director (CGE1). (1) Conducts the executive planning
and management of the division; (2) plans strategies and methods for
educating the public health and emergency response communities about
the SNS and its effective use; (3) represents the SNS in State, local,
and Federally sponsored exercises to test community response to a
catastrophic health event; (4) directs and monitors a comprehensive
strategy for managing and executing the critical systems in operating a
successful commercial good manufacturing practice compliance program;
(5) provides medical, pharmaceutical, and scientific oversight of the
SNS formulary; (6) partners with other governmental agencies, public
health organizations, and commercial entities with interest and
involvement in SNS activities and information; and (7) coordinates the
Stockpile Configuration Management Board that is responsible for
reviewing, reconciling, and adjusting SNS package and kit design and
contents to maintain consistency with medical, scientific, resource,
and end user requirements.
Logistics Branch (CGEB). (1) Defines operational requirements once
the SNS formulary is established by the Office of the Director and HHS
Public Health Emergency Countermeasures Enterprise (PHEMCE); (2)
manages the procurement of medical materiel to meet those requirements
through the CDC Federal procurement system; (3) manages and tracks the
expenditure of DSNS funds for the procurement, storage, and transport
of medical materiel assets; (4) supervises the storage of the SNS 12-
hour Push Packages; (5) manages the development and oversight of
contracts for Stockpile Managed Inventory (SMI) and Vendor Managed
Inventory (VMI) with commercial manufacturers and distributors of
medical materiel; (6) acquires facilities and provides the
infrastructure for storage of SNS assets; (7) manages the rotation of
dated products in the 12-hour Push Packages, in SMI, and in VMI; (8)
coordinates the physical security and safety of SNS assets with all
storage sites through the Office of Security and Emergency
Preparedness; (9) in full exercises or upon a Federal deployment of the
SNS, provides logistics expertise for the Technical Advisory Response
Unit (TARU) or other deployable/deployed teams that will accompany the
SNS to the scene of the chemical/nerve agent or bio-terrorism event as
well as for the team staffing the DSNS Team Room in the CDC Emergency
Operations Center; (10) coordinates the recovery of unused SNS assets
that will be returned to the SNS inventory which were deployed in an
actual chemical/nerve agent or bio-terrorism event, including the
recovery of SNS air cargo containers; (11) maintains the capacity to
transport any and all SNS assets by overseeing contractual arrangements
with commercial cargo carrier partners; (12) stores and maintains
vaccines, therapeutic blood products, and antitoxins in selected
repositories designated for managing and shipping these and other
special medical countermeasures; (13) manages the forward deployment
and sustainment of CHEMPACK chemical countermeasures in State-
determined locations throughout the U.S. in conjunction with the other
functional areas of DSNS; (14) manages the routine maintenance of SNS
equipment; (15) manages the Shelf Life Extension Program in
coordination with the Food and Drug Administration and the Department
of Defense; (16) serves as a storage and distribution source to the
Department of Defense for biologic products; (17) provides continuing
development of the Federal Medical Stations (FMS) program to deploy a
surge capability throughout the Nation; and (18) coordinates quality
assurance and quality control visits of stockpile assets.
Program Preparedness Branch (CGEC). (1) Coordinates the
development, refinement, and dissemination of guidance for CDC-funded
public health project areas to plan for and build the infrastructure
and systems necessary to manage and use deployed SNS assets; (2)
analyzes the overall developmental needs of personnel in State/local
Public Health Preparedness Programs and creates, implements, and
manages technical assistance and other developmental activities
designed to meet those needs; (3) coordinates DSNS supported exercises
with the Response Branch and project area Preparedness Plans; (4)
collaborates with the Division of State and Local Readiness (DSLR) by
providing support for their responsibilities as project officers
relative to the SNS components of the CDC Public Health and Emergency
Preparedness cooperative agreement and supplemental awards; (5) reviews
response plans of each of the CDC funded project areas and all Cities
Readiness Initiative (CRI) participants to effectively manage and use
deployed SNS assets; (6) functions as the primary agent for the CR1,
providing assistance to State and local governments and public health
agencies in engaging communities of major metropolitan areas to prepare
for effective responses to large scale bioterrorist events by
dispensing antibiotics and other medical supplies to their entire
populations, if necessary, within 48 hours of the decision to do so;
(7) plans, designs and prepares SNS related communications and select
educational materials support of State/local SNS Preparedness Programs;
(8) provides health communications guidance and products before,
during, and after an event to assist State/local SNS Preparedness
Program personnel and other public health officials in dealing with the
public; (9) serves as the DSNS point of contact for collaboration with
various Federal agencies and nongovernmental organizations (e.g.,
ASTHO, NACCHO) on programmatic initiatives and issues affecting State/
local SNS preparedness; (10)
[[Page 14452]]
collaborates with the DSNS Response and Logistics Branches on special
projects to ensure smooth implementation and successful ongoing
performance; and (11) during exercises or upon a Federal deployment of
the SNS assets, provides Project Area liaison expertise for the TARU
and for the DSNS Team Room of the CDC EOC.
Planning and Analysis Branch (CGED). (1) Supervises the design,
implementation, and day-to-day execution of processes and systems to
improve cost analysis, cost evaluation, planning and financial
management for DSNS; (2) manages the development of program policies
and procedures as well as performing periodic analysis of existing
policies to assess compliance and requirements; (3) coordinates in
collaboration with the other branches the development, testing,
implementation, training, and selected operations of DSNS's unique
information management systems and technology; (4) monitors and manages
reporting of DSNS performance measures; (5) provides project management
for new missions and initiatives within the division; (6) provides
leadership in issue and risk management, business transformation, and
change management; (7) provides support to the Veterans Administration
(VA) contracting office by acting as a primary liaison between DSNS and
the VA National Acquisition Center; (8) maintains contract management
responsibility within DSNS; and (9) develops, in collaboration with
various contractors and universities, models for use by Project Areas
in implementing SNS elements of their Public Health Preparedness
Programs.
Response Branch (CGEE). (1) Plans and manages response operations
of the DSNS during day-to-day operations and activation in response to
emergencies and exercises; (2) supervises the preparation and readiness
of all on site and off site response coordination facilities to
maintain each in a ready state, including oversight of all related
equipment, plans, and procedures; (3) manages the development,
coordination, and maintenance of DSNS response and deployment plans;
(4) supervises the staffing, preparation, and readiness of TARU and
Team Room staff to respond to emergencies (5) manages the planning,
coordination, and conduct of internal and partner training; (6) manages
the planning, coordination, and conduct of internal DSNS exercises and
participation in Federal, State, and local exercises; (7) manages the
DSNS Corrective Action Program for exercises and responses to actual
emergencies; (8) manages personnel transport capability through
overseeing and exercising contractual arrangements with the contract
air service partner; (9) manages DSNS personal and program response
communications devices and systems; (10) in full exercises or upon a
Federal deployment of the SNS, provides staff for the SNS Team Room in
the CDC EOC as well as for the TARU that will accompany the SNS assets;
(11) participates in periodic Quality Assurance/Quality Control visits
to SNS storage sites coordinated by the Logistics Branch; and (12)
oversees the day-to-day operation and administration of DSNS' Stockpile
Resource Planning (SRP) solution to ensure real time access to mission
critical data and provide 24/7/365 redundant network infrastructure in
coordination with ITSO.
Division of Select Agents and Toxins (CGF). The Division of Select
Agents and Toxins (DSAT): (1) Conducts registration of entities with
the United States (academic, military, commercial, private, Federal and
non-Federal government) that use, possess and transfer select agents
and toxins; (2) establishes and maintains a national database of all
entities that possess select agents; (3) inspects entities to ensure
that bio-safety and biosecurity regulations and national standards are
met; (4) approves all select agent or toxin transfers; (5) receives and
investigates reports of theft, loss, or release of a select agent or
toxin; (6) partners with other government agencies, public health
organizations, and registered entities to ensure compliance with the
Select Agent Regulations; (7) issues permits for the importation of
etiologic agents and hosts or vectors of human disease; and (8)
provides guidelines and training to regulated community on
requirements.
Office of the Director (CGF1). (1) Manages operations; (2) provides
scientific leadership and consultation; (3) coordinates and supports
the CDC Intra-governmental Select Agent and Toxin Technical Advisory
Committee and the development and implementation of training programs
for select agent inspectors; (4) provides oversight over the execution
of regulatory rulemaking activities associated with the DSAT Select
Agent and Import Permit Programs; (5) provides leadership and guidance
in the area of biosafety; (6) manages and responds to reports of
potential theft, loss, or release of select agents; (7) coordinates
special inspections and other oversight or incidence response
activities involving highly complex entities, including facilities that
house BSL-4 laboratories; and (8) provides input to divisional training
programs and outreach activities for the regulated community.
Operations Branch (CGFB). (1) Conducts on-site inspections of
entities that use, possess and transfer select agents and toxins; (2)
schedules and coordinates on-site inspections; (3) reviews entity
applications, amendments and other entity documentation; (4) prepares
reports of on-site inspections and conducts follow-up on noted
deficiencies; (5) maintains entity files to ensure that the Program has
the most current and accurate information; (6) communicates with
entities Responsible Officials on any issues related to applications,
amendments, inspections, and other entity documentation; (7)
coordinates all activities related to operations with the records
management group; and (8) serves as a liaison for the USDA, APHIS
Select Agent Program.
Program Management and Operations Branch (CGFC). (1) Provides
oversight and leadership over all business activities for the Division;
(2) manages all space and facilities issues for DSAT; (3) develops DSAT
budget planning and formulation; (4) provides leadership for DSAT
management team and oversight on budget execution activities; (5)
coordinates strategic planning/operations; (6) provides oversight on
all contract and grant formulation, award, and administration; (7)
manages division IT development, operations, and compliance; (8)
manages all negotiation and/or oversight of Inter- and Intra-Agency
Agreements, Memorandums of Agreements, and Service Level Agreement
between the division and various entities/organizations; (9) provides
property management oversight, assignment, administration, and
accountability; and (10) interacts with the appropriate CDC and OPHPR
business and operations offices.
Program Services Branch (CGFD). (1) Processes requests for transfer
of select agents and toxins; (2) processes permit applications to
import etiological agents, hosts, and vectors of human disease (not
limited to select agents) into the United States; (3) evaluates
entities' security plans and practices and submits reports to entities'
file managers; (4) manages the security risk assessment (SRA) process
to ensure that no restricted persons have access to select agents and
toxins; (5) provides consultation on DSAT security policies and
practices; (6) processes reports of select agents or toxins identified
through diagnosis, verification, or proficiency testing; (7) reviews
non-compliance issues, assists with evidence gathering, makes
recommendations
[[Page 14453]]
concerning non-compliance issues, drafts compliance letters and tracks
non-compliance issues; (8) assists in the writing and tracking of
Federal Register notices and other legal documents for the Division;
(9) serves as liaison for DSAT for the HHS Office of Inspector General
and Federal Bureau of Investigation (FBI); (10) processes requests for
exemptions for investigational products that are, bear, or contain
select agents or toxins, or to provide a response to a public health
emergency; (11) works with the FBI and the DSAT ADB on criminal
investigations of the theft or loss of select agents or toxins; (12)
coordinates all emergency notification functions; and (13) manages the
Program's sharing of select agent information with the States.
Division of Emergency Operations (CGG). The Division of Emergency
Operations (DEO) utilizing the Incident Command System (ICS) structure:
(1) Staffs and utilizes the EOC to assist Centers and Offices to manage
the utilization of resources to support public health routine and
emergency situations, domestically and internationally; (2) serves as
the primary point of contact under the Homeland Security Presidential
Directive (HSPD-5) Emergency Support Function 8 (Public Health
and Medical Services); (3) maintains and operates the CDC National-
level EOC which serves as the focal point for collaboration and
information sharing throughout CDC, 24/7/365; (4) coordinates with all
CDC's Centers/Institute/Offices with planning, training, exercising,
reporting and coordinating logistical support during pre-response
activities and during responses; and (5) apprises CDC leadership and
outside agencies of CDC response activities and subject-matter expert
situational reports.
Office of the Director (CGG1). (1) Manages the day-to-day
operations of the division and provides leadership, resource
prioritization, and guidance during public health responses; (2)
coordinates the daily management of resources for the division
including budget, personnel, and acquisitions in coordination with
OPHPR Office of Management Services; (3) coordinates technology
improvements and information support requirements for the division and
EOC; (4) provides strategic planning to develop performance management
goals, objectives, and measurements for the division; (5) manages DEO's
scientific activities within the division and across CDC; (6) improves
the timeliness and accuracy of public health information gathering,
analysis, and sharing through knowledge management and situational
awareness in an effort to maximize the speed and accuracy of decision
making; and (7) provides a 24/7/365 situational awareness capability to
maximize accurate information flow.
Emergency and Risk Communications Branch (CGGB). (1) Identifies and
implements strategies for translation and delivery of CDC's emergency
risk communication messages and information to key targeted audiences
for maximum health impact; (2) coordinates and integrates cross-agency
communication activities to fulfill emergency risk communication
strategies to respond to public health emergencies; (3) provides
leadership and core staffing for the Joint Information Center in CDC's
EOC during public health emergencies; (4) serves as CDC's primary
communication liaison during public health emergencies to other
responding agencies to ensure communication coordination with local,
State, Federal, and international partners; (5) monitors, evaluates,
and refines risk and emergency communication messages and channels
messages based on feedback, communication research, and best practices;
(6) evaluates the reach and effectiveness of CDC's risk and emergency
communication messages and products; (7) ensures that the content of
CDC's emergency risk communication messages are accessible (available,
understandable, actionable) and disseminated to the public and target
audiences; (8) develops and manages selected channels to deliver
national emergency and terrorism-related messages; (9) coordinates the
distribution of emergency risk communication messages and information
through additional non-CDC channels and engagement mechanisms including
news media, social media networks, and partner outreach; (10) provides
an integrated marketing perspective to risk emergency communication;
(11) employs a systematic process for assessing public awareness,
knowledge, attitudes, reactions, and behaviors related to urgent health
threats, CDC's emergency risk communication messages, and CDC programs;
(12) uses the results of assessment process as input into agency
decision making and communication planning; (13) provides technical
assistance in emergency risk communication and operations to internal
and external partners and supports emergency risk communication
capacity building; and (14) sponsors/initiates original research
related to emergency risk communication messages on customer,
stakeholder, and partner needs, interests, and reactions.
Logistics Support Branch (CGGC). (1) Ensures policies, plans and
procedures are in place to provide logistical, administrative, and
crisis movement support to CDC deployed personnel and response assets,
including communications; (2) provides deployment support for CDC
personnel to provide on-site logistical and administrative support to
CDC response assets, including communications; (3) coordinates with
external logistical and transportation offices during emergencies; (4)
advises the DEO Director regarding logistics and transportation
activities and provides logistics and transportation planning support
for operations plan development and during emergency responses; (5)
manages property accountability; procures, maintains, manages, tracks,
and coordinates movement of supplies, services, and equipment for CDC
including specimens and hazardous cargo shipments in response to
emergency deployment operations; (6) coordinates with the CDC Office of
Health and Safety (OHS) and other CDC entities for all CDC medical
evacuation missions involving the movement of suspected infectious and
contagious patients; (7) coordinates off-site communications and reach-
back capabilities, to include real time exchange of information for
deployed personnel and teams; and (8) manages the operation and
employment of the CDC aircraft.
Operations Branch (CGGD). (1) Maintains a 24/7/365 capability to
respond to emergencies and coordinate emergency management processes
and protocols across CDC; (2) monitors national and international
public health emergencies and maintains a common operating picture for
CDC leadership and HHS/ASPR; (3) serves as the central point of contact
between CDC and public health agencies nationally and internationally
for emergency management and response; (4) supports the myriad of
sophisticated audiovisual, administrative, and communication functions,
including equipment, necessary to maintain a state-of-the-art national
emergency operations center; (5) identifies the requirements to fully
staff all of the functional roles of the IMS to meet a 24/7/365, all
hazard, public health emergency, including identifying personnel across
CDC to staff operations functional roles; (6) conducts coordination,
planning, and training necessary to implement Continuity of Operations
(COOP); (7) coordinates movement/deployment of
[[Page 14454]]
resourced requirements with logistics; (8) ensures the agency
deployment coordination plan represents a comprehensive strategy to
identify, recruit, prepare, and maintain a workforce capable of
responding rapidly and efficiently to all events requiring CDC public
health response leadership, guidance, or support; (9) maintains and
coordinates deployment activities supporting deployer health and safety
requirements; and (10) monitors, tracks, and assists HHS/Office of
Force Readiness and Deployment (OFRD) deployments which utilize
Commissioned Corps officers stationed at CDC.
Plans, Training, Exercise and Evaluation Branch (CGGE). (1)
Develops CDC emergency operations plans, event-specific incident
annexes, and national special security event plans, and collaborates
across CDC to facilitate development of internal standard operating
procedures to support these plans; (2) acts as planning liaison to
other organizations and reviews, analyzes and provides comments on
Federal and national plans or inquires; (3) provides policy oversight
and coordinates the incorporation of national policy into CDC
operations plans; (4) represents the agency regarding operational
planning and facilitates or participates in planning-focused work
groups; (5) manages the CDC exercise and incident response evaluation
program; (6) coordinates training and exercise programs and provides
feedback and recommendations for After Action Reports for activities
conducted at the CDC level; (7) collaborates with SMEs across CDC and
external partners to facilitate evaluation of training, planning, and
exercises to improve public health preparedness; (8) develops and
coordinates Corrective Action Plans and tracks Improvement Plans; (9)
coordinates Improvement Plans with CDC SMEs; (10) designs and delivers
up-to-date CDC and preparation for exercises in emergency response
training to prepare staff for emergency situations; (11) tracks CDC
responder and staff certifications; (12) ensures that Division training
programs support Agency goals; (13) manages exercises to test the
readiness of the CDC IMS and ensures it supports the National Planning
Scenarios; (14) coordinates and manages CDC's participation in
pertinent external all-hazards exercises; (15) serves as the
Chairperson of the CDCs Exercise Steering Committee and manages the
CDC's internal exercise program in collaboration with subject matter
experts across CDC; and (16) facilitates the involvement of States and
other response partners in CDC exercises.
Dated: March 11, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-6372 Filed 3-24-10; 8:45 am]
BILLING CODE 4160-18-M