Office of the Assistant Secretary for Preparedness and Response; Statement of Organization, Functions, and Delegations of Authority, 35035-35038 [2010-14997]
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Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
this case, the complaint does not allege
that U-Haul and Budget reached an
agreement, despite Mr. Magyar’s report
to his bosses that he privately
encouraged Budget to raise its rates ‘‘and
they did.’’ See Complaint Paragraph 19.
Even if no agreement was reached it
does not necessarily mean that no
competitive harm was done.4 An
unaccepted invitation to collude may
facilitate coordinated interaction by
disclosing the solicitor’s intentions and
preferences. For example, in this case
Budget learned from Mr. Magyar that if
Budget raised its rates U-Haul would
not undercut Budget. Thus, the
improper communication from U-Haul
could have encouraged Budget to raise
rates. Similarly, the public statements
made by the CEO of U-Haul could have
encouraged competitors to raise rates.
Although this case involves
particularly egregious conduct, it is
possible that less egregious conduct may
result in Section 5 liability. It is not
essential that the Commission find
repeated misconduct attributable to
senior executives, or define a market, or
show market power, or establish
substantial competitive harm, or even
find that the terms of the desired
agreement have been communicated
with precision.
III. The Proposed Consent Order
U-Haul has signed a consent
agreement containing the proposed
consent order. The proposed consent
order consists of seven sections that
work together to enjoin U-Haul from
inviting collusion and from entering
into or implementing a collusive
scheme.
Section II, Paragraph A of the
proposed consent order enjoins U-Haul
from inviting a competitor to divide
markets, to allocate customers, or to fix
prices. Section II, Paragraph C prohibits
U-Haul from entering into, participating
in, maintaining, organizing,
implementing, enforcing, inviting,
offering or soliciting an agreement with
any competitor to divide markets, to
allocate customers, or to fix prices.
Section II, Paragraph B bars U-Haul
sroberts on DSKD5P82C1PROD with NOTICES
4 The
Commission has previously explained that
there are several legal and economic reasons to
punish firms that invite collusion even when
acceptance cannot be proven. First, it may be
difficult to determine whether a particular
solicitation has or has not been accepted. Second,
the conduct may be harmful and serves no
legitimate business purpose. Third, even an
unaccepted solicitation may facilitate coordinated
interaction by disclosing the intentions or
preferences of the party issuing the invitation. In
the Matter of Valassis Communications, Inc.,
Analysis of Agreement Containing Consent Order
To Aid Public Comment, 71 Fed. Reg. 13976,
13978-79 (Mar. 20, 2006). See generally P. Areeda
& H. Hovenkamp, VI Antitrust Law ¶1419 (2003).
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from discussing rates with its
competitors, with a proviso permitting
legitimate market research.
The proviso in Section II, Paragraph D
prevents the proposed order from
interfering with U-Haul’s efforts to
negotiate prices with prospective
customers, and it would permit U-Haul
to provide investors with considerable
information about company strategy.
This proviso also permits U-Haul to
communicate publicly any information
required by the federal securities laws.
Sections III, IV, V, and VI of the
proposed order include several terms
that are common to many Commission
orders, facilitating the Commission’s
efforts to monitor respondents’
compliance with the order. Section IV,
Paragraph A requires a periodic
submission to the Commission of
unredacted copies of certain internal UHaul documents. This provision is
necessary because U-Haul impeded the
Federal Trade Commission’s
investigation of this matter. Specifically,
U-Haul submitted to the Commission, in
response to a subpoena duces tecum,
documents authored by Mr. Shoen, from
which were redacted many of the
sentences quoted in the complaint. In
the Commission’s view, there was no
justification for the redaction. The
proposed order should deter repetition
of this conduct.
Finally, Section VII provides that the
proposed order will expire in 20 years.
By direction of the Commission.
Donald S. Clark,
Secretary.
Statement of Chairman Leibowitz,
Commissioner Kovacic, and
Commissioner Rosch
The Commission today has entered
into a consent agreement with U-Haul
and its parent company, AMERCO,
resolving the Commission’s allegation
that they attempted to collude on truck
rental prices. The parties have settled an
invitation-to-collude case and not a
Sherman Antitrust Act Section 1
conspiracy case. Put differently, the
complaint in this case alleges an unfair
method of competition in violation of
Section 5 of the FTC Act that does not
also constitute an antitrust violation.
Invitations to collude are the
quintessential example of the kind of
conduct that should be – and has been
– challenged as a violation of Section 5
of the Federal Trade Commission Act,5
5 In re Valassis Commc’ns, Inc., F.T.C. File No.
051-008, 2006 FTC LEXIS 25 (April 19, 2006)
(Complaint); In re MacDermid, Inc., F.T.C. File No.
991-0167, 1999 FTC LEXIS 191 (Feb. 4, 2000)
(Complaint, Decision and Order); In re Stone
Container Corp., 125 F.T.C. 853 (1998) (June 3,
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35035
which may limit follow-on private
treble damage litigation from
Commission action while still stopping
inappropriate conduct. In contrast to
conspiracy claims that would violate
Section 1, invitations to collude do not
require proof of an agreement; nor do
they require proof of an anticompetitive
effect. The Commission has not alleged
that Respondents entered into an
agreement with Budget or any other
competitors in violation of Section 1.
Today’s Commission action is instead
based on evidence that Respondents
unilaterally attempted to enter into such
an agreement. The Commission
therefore has reason to believe that
Respondents engaged in conduct that is
within Section 5’s reach.
[FR Doc. 2010–14870 Filed 6–18–10: 8:45 am]
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Office of the Assistant Secretary for
Preparedness and Response;
Statement of Organization, Functions,
and Delegations of Authority
Part A, Office of the Secretary,
Statement of Organization, Functions,
and Delegations of Authority of the
Department of Health and Human
Services (HHS) is being amended at
Chapter AN, Office of Public Health
Emergency Preparedness (OPHEP), as
last amended at 71 FR 38403–05 dated
July 6, 2006. This organizational change
is to retitle the OPHEP as the Office of
the Assistant Secretary for Preparedness
and Response (ASPR), and to realign the
functions of ASPR to reflect the changes
mandated by the Pandemic and AllHazards Preparedness Act (Pub. L. 109–
417) (PAHPA). The changes are as
follows.
I. Under Part A, Chapter AN, ‘‘Office
of Public Health Emergency
Preparedness (AN),’’ delete in its
entirety and replace with the following:
CHAPTER AN: Office of the Assistant
Secretary for Preparedness and
Response
AN.00 Mission
AN.10 Organization
AN.20 Functions
1998) (Complaint, Decision and Order); In re
Precision Moulding Co., 122 F.T.C. 104 (Sept. 3,
1996) (Complaint, Decision and Order); In re YKK
(USA) Inc., 116 F.T.C. 628 (July 1, 1993)
(Complaint); In re A.E. Clevite, Inc., 116 F.T.C. 389
(June 8, 1993) (Complaint); In re Quality Trailer
Products Corp., 115 F.T.C. 944 (Nov. 5, 1992)
(Complaint).
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Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
Section AN.00 Mission
On behalf of the Secretary of HHS, the
Assistant Secretary for Preparedness
and Response (ASPR) serves as the
principal advisor on all matters related
to Federal public health and medical
preparedness and response for public
health emergencies. The ASPR serves as
the primary advisor to the Secretary of
HHS for national public health and
medical preparedness, including
Emergency Support Function 8 (ESF 8).
Furthermore, the ASPR exercises the
responsibilities of the Secretary with
respect to direction of ESF 8 activities,
and coordination of HHS assets in
accord with the PAHPA, including the
Strategic National Stockpile (SNS) and
the Cities Readiness Initiative (CRI).
ASPR leads the Federal public health
and medical response to acts of
terrorism, nature, and other public
health and medical emergencies;
coordinates the development and
implementation of national policies and
plans related to public health and
medical preparedness and response;
oversees the advanced research,
development, and procurement of
qualified countermeasures and qualified
pandemic or epidemic products;
coordinates services for at-risk
individuals, preparedness planning, and
response efforts; and provides guidance
in international programs, initiatives,
and policies that deal with public health
and medical emergency preparedness
and response. ASPR is responsible for
ensuring a consolidated approach to
developing public health and medical
preparedness and response capabilities
and leading and coordinating the
relevant activities of the HHS Operating
Divisions (OPDIVs) and Staff Divisions
(STAFFDIVs).
The Office of the ASPR is charged
with strategic and operational
responsibilities for medical and public
health preparedness and response. The
Immediate Office of the ASPR provides
staff guidance to maximize operational
effectiveness and is responsible for
reviewing staff recommendations of
policies developed to further the ASPR
and HHS mission.
Strategic responsibilities include
policy development and
implementation, oversight of the
National Health Security Strategy, and
coordination across HHS, with other
Federal agencies, and state, local and
private sector entities. The ASPR is the
primary HHS liaison to and leads
coordination of Homeland and National
Security Councils’ policy initiatives and
is responsible for the integration of
national public health and medical
preparedness and response efforts into
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the Federal interagency planning and
policy processes.
Operational responsibilities include
(but are not limited to) the following:
• Serves as the Incident Manager for
ESF 8 during activations;
• Directs and coordinates the
development of ESF 8 Playbooks,
Concepts of Operations (CONOPS),
Operating Plans (OPLANS), and other
planning or procedural documents that
set forth how HHS response assets are
to be employed in various emergency
contexts;
• Coordinates preparedness and
response planning with state, local, and
private sector entities in furtherance of
the National ESF 8 mission;
• Assures that planning and
procedural documents make explicit the
respective roles of ASPR Headquarters
staff, ASPR Regional Emergency
Coordinators, the ASPR field incident
management teams, HHS Secretary’s
Operations Center (SOC), Centers for
Disease Control and Prevention (CDC)
Headquarters staff, the Director’s
Emergency Operations Center, Federal
Emergency Management Agency
(FEMA) Operations Center, Department
of Homeland Security (DHS) National
SOC, CDC field staff such as SNS
consultants, and other HHS division
response assets;
• Assures clarity in state ESF 8
planning by convening state ESF 8
planning meetings with the Department
of State, ASPR, CDC, and other
organizations as necessary to ensure
medical, public health, and human
service functions are integrated;
• Manages the Hospital Preparedness
Program (HPP) Cooperative Agreement,
which provides financial and technical
support for medical preparedness to
health care facilities throughout the
country;
• Facilitates HHS participation in
development of International Health
Regulations (IHR);
• Manages the National Disaster
Medical System (NDMS);
• Manages the Biomedical Advanced
Research and Development Authority
(BARDA); and
• Manages and operates the HHS
SOC.
Section AN.10 Organization
The Office of the Assistant Secretary
for Preparedness and Response is
headed by the Assistant Secretary for
Preparedness and Response (ASPR),
who reports directly to the Secretary,
and includes the following components:
• Immediate Office/Chief Operating
Officer (ANA)
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• Office of Biomedical Advanced
Research and Development Authority
(ANB)
• Office of Preparedness and
Emergency Operations (ANC)
• Office of Acquisitions Management,
Contracts, and Grants (AND)
• Office of Policy and Planning (ANE)
• Office of Financial Planning and
Analysis (ANF)
Section AN.20 Functions
A. Immediate Office/Chief Operating
Officer (ANA). The Immediate Office
(IO) develops and maintains liaison
relationships with HHS operating and
staff divisions and represents HHS at
interagency meetings, as required. The
IO provides information to those
individuals and organizations that
inquire about or express interest in
ASPR. The IO establishes and maintains
effective communications to advise midand long-range plans to emphasize
recent or forthcoming changes in plans
and regulations, to receive effective
feedback; and explore ways to
implement suggestions for improved
business operations and performance.
The IO is responsible for the direction
of executive level business management
operations and managing division staff
coordination. The IO is responsible for
the timely and quality execution of all
management related matters under the
ASPR mission. The IO provides staff
guidance to maximize operational
effectiveness. The IO is responsible for
reviewing staff recommendations of
policies developed to further the ASPR
and HHS mission. The IO staff considers
the potential impact of political, social,
economic, technical, and administrative
factors on the recommended policies
and formally recommends actions on
approving/disapproving policies to the
ASPR.
The Immediate Office/Chief Operating
Officer (ANA) includes the following
components:
• Division of Administrative
Management (ANA1)
• Division of Communications
(ANA2)
• Division of Legislative Coordination
(ANA3)
• Division of Workforce Development
(ANA4)
• Division of Executive Secretariat
(ANA5)
The Immediate Office/Chief Operating
Officer provides for the facility,
logistics, and infrastructure support
services necessary to maintain day-today operations of ASPR; the office
provides communication and outreach
guidance and support for all external
communications, including legislative
and executive branch questions and
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inquiries, and serves as the principal
advisor to the ASPR on all legislative
strategies to fulfill the Office of the
ASPR and the HHS mission under the
PAHPA. Furthermore, the Office covers
the functions of Human Resources,
Organization and Employee
Development, Ethics, and United States
Public Health Service (USPHS) Liaison,
and develops and maintains liaison
relationships with HHS OPDIVs and
STAFFDIVs. The Chief Operating
Officer manages correspondence control
for the Assistant Secretary. In addition,
the office provides oversight in the
development and operation of tracking
systems, which are designed to identify
and resolve early warnings and
bottleneck problems with executive
correspondence.
B. Office of Biomedical Advance
Research and Development Authority
(ANB). The Office of Biomedical
Advanced Research and Development
Authority (BARDA), established in
April 2007 in response to the Pandemic
and All-Hazards Preparedness Act of
2006, serves preparedness and response
roles to provide medical
countermeasures (MCM) in order to
mitigate the medical consequences of
chemical, biological, radiological, and
nuclear (CBRN) threats and agents and
emerging infectious diseases, including
pandemic influenza. BARDA executes
this mission by facilitating research,
development, innovation, and
acquisition of medical countermeasures
and expanding domestic manufacturing
infrastructure and surge capacity of
these medical countermeasures.
BARDA is headed by a Deputy
Assistant Secretary, and includes the
following components:
• Division of Influenza (ANB1)
• Division of Emerging Infectious
Diseases (ANB2)
• Division of Chemical, Biological,
Radiological and Nuclear Threats
(ANB3)
• Division of Strategic Science and
Technology (ANB4)
• Division of Regulatory and Quality
Affairs (ANB5)
C. Office of Preparedness and
Emergency Operations (ANC). The
Office of Preparedness and Emergency
Operations (OPEO) is responsible for
providing a well-integrated
infrastructure that supports the
Department’s capabilities to prevent,
prepare for, respond to and recover from
natural public health and medical
threats and emergencies. OPEO leads
the preparedness and response activities
required to coordinate public health and
medical response systems and activities
with relevant Federal, state, Tribal,
Territorial, local, and international
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communities under ESF 8, ESF 6 and
ESF 14 of the NRF. OPEO is also
responsible for the HHS Continuity of
Operations (COOP) and the
development of the ASPR COOP Plan.
The Office of Preparedness and
Emergency Operations (OPEO) is
headed by a Deputy Assistant Secretary,
and includes the following components:
• Division of Mass Care (ANC1)
• Division of Operations (ANC2)
• Division of Planning (ANC3)
• Division of Infrastructure
Coordination (ANC4)
• Division of Emergency Care
Coordination Center (ECCC) (ANC5)
• Division of National Disaster
Medical System (NDMS) (ANC6)
D. Office of Acquisitions
Management, Contracts and Grants
(AND). The Office of Acquisitions
Management, Contracts and Grants
(AMCG) provides ASPR with
acquisition support to prepare and
respond to the adverse health
emergencies and disasters and provides
contractual support to the Immediate
Office of the ASPR, BARDA, Office of
Policy and Planning (OPP), and Office
of Financial Planning and Analysis
(FPA). The office focuses on providing
acquisition and contractual support to
BARDA in two specific program
divisions: Chemical, Biological,
Radiological, and Nuclear Threats
(CBRNT) and Influenza (Flu). The
Division of Acquisition Programs
Support (APS) provides a wide range of
program management support to the
ASPR as well as direct program support
to the following BARDA divisions—
CBRN, Influenza, Emerging Infectious
Diseases, and Strategic Science and
Technology. Functional support
activities of the Office include
requirements analysis for statement of
work/statement of operations
development, acquisition strategy
development and tracking assistance to
include contractual milestone
development with measurable success
criteria. The office also serves as ASPR’s
focal point for management, leadership
and administration of discretionary and
mandatory grants and cooperative
agreements.
The Office of Acquisitions
Management, Contracts and Grants
(AMCG) is headed by a Director, and
includes the following components:
• Division of ASPR Support (AND1)
• Division of BARDA Support
(AND2)
• Division of Acquisition Programs
Support (AND3)
• Division of Grants Management
(AND4)
• Division of Acquisition Policy
(AND5)
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35037
E. Office of Policy and Planning
(ANE). The Office of Policy and
Planning (OPP) is responsible for policy
development, analysis and
coordination, research and evaluation,
and strategic planning. The OPP: (1)
Analyzes proposed policies,
Presidential Directives, and regulations,
and develops short- and long-term
policy objectives for ASPR; (2) leads the
development and implementation of an
integrated ASPR approach to policy; (3)
serves as the focal point for the
Homeland Security Council (HSC) and
the National Security Council (NSC)
policy coordination activities on behalf
of ASPR and represents the ASPR, as
appropriate, in interagency policy
coordination meetings and activities; (4)
undertakes studies of preparedness and
response issues, identifying gaps in
policy, and initiating policy planning
and formulation to fill these gaps; (5)
leads in the implementation of the
PAHPA and is responsible for
developing the quadrennial National
Health Security Strategy and
implementation plan for public health
emergency preparedness and response;
(6) develops strategic partnerships with
stakeholders and leads in the
development of ASPR strategies for
knowledge and information
management; (7) manages the
development of the ASPR strategic plan,
annual plan, and balanced scorecard,
and compiles the ASPR Organizational
Assessment by tracking Key
Performance Indicators as part of the
ASPR strategic management system; (8)
develops and maintains liaison
relationships with strategic planning
personnel of HHS and ESF 8 partner
organizations; and (9) manages strategic
planning program objectives to ensure
programs are consistent with ASPR
goals and monitors program
development to make sure that
timelines are met accordingly.
OPP is headed by a Deputy Assistant
Secretary and includes the following
components:
• Division of Policy and Strategic
Planning (ANE1)
• Division of Medical
Countermeasures Policy and Planning
(ANE2)
• Division of Health Systems Policy
(ANE3)
• Division of International Health
(ANE4)
• Division of Biosecurity/Biosafety/
Countering Biologic Threats (ANE5)
F. Office of Financial Planning and
Analysis (ANF). The Office of Financial
Planning and Analysis (OFPA) ensures
that ASPR’s financial resources are
aligned to its strategic priorities. OFPA
carries out its responsibilities by
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formulating, monitoring, and evaluating
ASPR budgets and financial plans that
support program activities and ensures
the effective and efficient execution of
ASPR financial resources. OFPA has
administrative oversight of the
Administration & Finance section of the
emergency management group that is
activated under ESF 8 of the NRF during
a public health emergency. On behalf of
the ASPR, OFPA serves as the primary
point of contact with the Office of the
Assistant Secretary for Financial
Resources, the Office of Management
and Budget (OMB) and Congressional
Appropriation Committees. In
compliance with OMB Circular A–123,
FPA ensures accountability and
effectiveness of ASPR’s financial
programs and operations by
establishing, assessing, correcting, and
reporting on internal controls.
The Office of Financial Planning and
Analysis is headed by a Director and
includes the following components:
• Division of Budget Formulation and
Execution (ANF1)
• Division of Requisition Services
(ANF2)
• Division of Management Assurance
(ANF3)
• Division of Administration and
Finance (ANF4)
II. Delegations of Authority. All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegation, provided they are
consistent with this reorganization.
Dated: June 14, 2010.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2010–14997 Filed 6–18–10; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities; Proposed Collection;
Comment Request
sroberts on DSKD5P82C1PROD with NOTICES
AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Avoiding Readmissions in Hospitals
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Serving Diverse Patients.’’ In accordance
with the Paperwork Reduction Act, 44
U.S.C. 3501–3520, AHRQ invites the
public to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by August 20, 2010.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Avoiding Readmissions in Hospitals
Serving Diverse Patients
An important part of AHRQ’s mission
is to disseminate information and tools
that can support improvement in quality
and safety in the U.S. health care
community. The transition process from
the hospital to the outpatient setting is
nonstandardized and frequently
inadequate in quality. One in five
hospital discharges is complicated by an
adverse event (AE) within 30 days, often
leading to an emergency department
visit and/or rehospitalization. Many
readmissions stem from errors that can
be directly attributed to the
discontinuity and fragmentation of care
at discharge. High rates of low health
literacy, lack of coordination in the
‘‘hand-off’ from the hospital to
community care, gaps in social
supports, and other limitations also
contribute to the risk of
rehospitalization.
Boston University Medical Center
(BUMC), through a grant from AHRQ,
previously defined the discharge
process and determined what
improvements could be made to
improve this care transition for patients.
This new process was called the ‘‘reengineered discharge’’ (RED). The RED
consists of 11 elements, including
educating the patient throughout the
hospital stay, making follow-up
appointments, and giving the patient a
written discharge plan. The RED was
tested in a randomized controlled trial
in an academic safety net hospital at
BUMC with English speaking, general
medical patients being discharged to
home or community settings. Results of
this trial of 749 patients showed a
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reduction in rehospitalizations within
30 days and emergency department
visits following hospital discharge.
Participants also followed up with
primary care providers more often and
reported higher patient satisfaction with
the discharge process. Project RED
researchers created several tools to help
hospitals replicate RED. After AHRQ
and Project RED researchers fielded
many inquiries about how to implement
Project RED at hospitals nationwide,
AHRQ realized that the Project RED
Toolkit did not provide sufficient
guidance to potential replicators.
Various components of the RED were
not documented, and issues regarding
implementing the RED at hospitals
serving linguistically and culturally
diverse patient populations had not
been addressed. AHRQ has therefore
contracted with the RED researchers to
create a revised RED Toolkit that will
address these issues.
This proposed information collection
supports AHRQs mission by improving
upon the RED Toolkit. This project has
the following 3 goals:
(1) To revise the Project RED Toolkit
to comprehensively address all
components of the RED, as well as the
needs of culturally and linguistically
diverse patients;
(2) To pre-test the revised RED Toolkit
in ten varied hospital settings,
evaluating how the RED Toolkit is
implemented in varied hospital settings
by: (a) Documenting the implementation
process; (b) assessing the fidelity of
implementation; and (c) identifying the
factors that affect redesign fidelity,
including intensity of technical
assistance (TA).
(3) To modify the revised RED Toolkit
based on pre-testing and to disseminate
it.
BUMC will provide TA at two varying
levels. Four selected hospitals will
receive ‘‘train-the-trainer’’ TA, which
includes:
(1) Telephone assistance in
conducting a baseline needs assessment;
(2) Master trainer training;
(3) Access to Webinar trainings
specifically designed for each user
(nurse, IT professional, hospital
leadership, and pharmacist);
(4) An electronic template to print an
After Hospital Care Plan (AHCP)
booklet; and
(5) E-mails regarding updates to the
RED Web site and the opportunity to ask
questions about the newly revised and
enhanced RED tools and
implementation via telephone and
email.
Six selected hospitals will receive
intensive TA, which includes:
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]]>Agencies
[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35035-35038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14997]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Office of the Assistant Secretary for Preparedness and Response;
Statement of Organization, Functions, and Delegations of Authority
Part A, Office of the Secretary, Statement of Organization,
Functions, and Delegations of Authority of the Department of Health and
Human Services (HHS) is being amended at Chapter AN, Office of Public
Health Emergency Preparedness (OPHEP), as last amended at 71 FR 38403-
05 dated July 6, 2006. This organizational change is to retitle the
OPHEP as the Office of the Assistant Secretary for Preparedness and
Response (ASPR), and to realign the functions of ASPR to reflect the
changes mandated by the Pandemic and All-Hazards Preparedness Act (Pub.
L. 109-417) (PAHPA). The changes are as follows.
I. Under Part A, Chapter AN, ``Office of Public Health Emergency
Preparedness (AN),'' delete in its entirety and replace with the
following:
CHAPTER AN: Office of the Assistant Secretary for Preparedness and
Response
AN.00 Mission
AN.10 Organization
AN.20 Functions
[[Page 35036]]
Section AN.00 Mission
On behalf of the Secretary of HHS, the Assistant Secretary for
Preparedness and Response (ASPR) serves as the principal advisor on all
matters related to Federal public health and medical preparedness and
response for public health emergencies. The ASPR serves as the primary
advisor to the Secretary of HHS for national public health and medical
preparedness, including Emergency Support Function 8 (ESF 8).
Furthermore, the ASPR exercises the responsibilities of the Secretary
with respect to direction of ESF 8 activities, and coordination of HHS
assets in accord with the PAHPA, including the Strategic National
Stockpile (SNS) and the Cities Readiness Initiative (CRI).
ASPR leads the Federal public health and medical response to acts
of terrorism, nature, and other public health and medical emergencies;
coordinates the development and implementation of national policies and
plans related to public health and medical preparedness and response;
oversees the advanced research, development, and procurement of
qualified countermeasures and qualified pandemic or epidemic products;
coordinates services for at-risk individuals, preparedness planning,
and response efforts; and provides guidance in international programs,
initiatives, and policies that deal with public health and medical
emergency preparedness and response. ASPR is responsible for ensuring a
consolidated approach to developing public health and medical
preparedness and response capabilities and leading and coordinating the
relevant activities of the HHS Operating Divisions (OPDIVs) and Staff
Divisions (STAFFDIVs).
The Office of the ASPR is charged with strategic and operational
responsibilities for medical and public health preparedness and
response. The Immediate Office of the ASPR provides staff guidance to
maximize operational effectiveness and is responsible for reviewing
staff recommendations of policies developed to further the ASPR and HHS
mission.
Strategic responsibilities include policy development and
implementation, oversight of the National Health Security Strategy, and
coordination across HHS, with other Federal agencies, and state, local
and private sector entities. The ASPR is the primary HHS liaison to and
leads coordination of Homeland and National Security Councils' policy
initiatives and is responsible for the integration of national public
health and medical preparedness and response efforts into the Federal
interagency planning and policy processes.
Operational responsibilities include (but are not limited to) the
following:
Serves as the Incident Manager for ESF 8 during
activations;
Directs and coordinates the development of ESF 8
Playbooks, Concepts of Operations (CONOPS), Operating Plans (OPLANS),
and other planning or procedural documents that set forth how HHS
response assets are to be employed in various emergency contexts;
Coordinates preparedness and response planning with state,
local, and private sector entities in furtherance of the National ESF 8
mission;
Assures that planning and procedural documents make
explicit the respective roles of ASPR Headquarters staff, ASPR Regional
Emergency Coordinators, the ASPR field incident management teams, HHS
Secretary's Operations Center (SOC), Centers for Disease Control and
Prevention (CDC) Headquarters staff, the Director's Emergency
Operations Center, Federal Emergency Management Agency (FEMA)
Operations Center, Department of Homeland Security (DHS) National SOC,
CDC field staff such as SNS consultants, and other HHS division
response assets;
Assures clarity in state ESF 8 planning by convening state
ESF 8 planning meetings with the Department of State, ASPR, CDC, and
other organizations as necessary to ensure medical, public health, and
human service functions are integrated;
Manages the Hospital Preparedness Program (HPP)
Cooperative Agreement, which provides financial and technical support
for medical preparedness to health care facilities throughout the
country;
Facilitates HHS participation in development of
International Health Regulations (IHR);
Manages the National Disaster Medical System (NDMS);
Manages the Biomedical Advanced Research and Development
Authority (BARDA); and
Manages and operates the HHS SOC.
Section AN.10 Organization
The Office of the Assistant Secretary for Preparedness and Response
is headed by the Assistant Secretary for Preparedness and Response
(ASPR), who reports directly to the Secretary, and includes the
following components:
Immediate Office/Chief Operating Officer (ANA)
Office of Biomedical Advanced Research and Development
Authority (ANB)
Office of Preparedness and Emergency Operations (ANC)
Office of Acquisitions Management, Contracts, and Grants
(AND)
Office of Policy and Planning (ANE)
Office of Financial Planning and Analysis (ANF)
Section AN.20 Functions
A. Immediate Office/Chief Operating Officer (ANA). The Immediate
Office (IO) develops and maintains liaison relationships with HHS
operating and staff divisions and represents HHS at interagency
meetings, as required. The IO provides information to those individuals
and organizations that inquire about or express interest in ASPR. The
IO establishes and maintains effective communications to advise mid-
and long-range plans to emphasize recent or forthcoming changes in
plans and regulations, to receive effective feedback; and explore ways
to implement suggestions for improved business operations and
performance. The IO is responsible for the direction of executive level
business management operations and managing division staff
coordination. The IO is responsible for the timely and quality
execution of all management related matters under the ASPR mission. The
IO provides staff guidance to maximize operational effectiveness. The
IO is responsible for reviewing staff recommendations of policies
developed to further the ASPR and HHS mission. The IO staff considers
the potential impact of political, social, economic, technical, and
administrative factors on the recommended policies and formally
recommends actions on approving/disapproving policies to the ASPR.
The Immediate Office/Chief Operating Officer (ANA) includes the
following components:
Division of Administrative Management (ANA1)
Division of Communications (ANA2)
Division of Legislative Coordination (ANA3)
Division of Workforce Development (ANA4)
Division of Executive Secretariat (ANA5)
The Immediate Office/Chief Operating Officer provides for the
facility, logistics, and infrastructure support services necessary to
maintain day-to-day operations of ASPR; the office provides
communication and outreach guidance and support for all external
communications, including legislative and executive branch questions
and
[[Page 35037]]
inquiries, and serves as the principal advisor to the ASPR on all
legislative strategies to fulfill the Office of the ASPR and the HHS
mission under the PAHPA. Furthermore, the Office covers the functions
of Human Resources, Organization and Employee Development, Ethics, and
United States Public Health Service (USPHS) Liaison, and develops and
maintains liaison relationships with HHS OPDIVs and STAFFDIVs. The
Chief Operating Officer manages correspondence control for the
Assistant Secretary. In addition, the office provides oversight in the
development and operation of tracking systems, which are designed to
identify and resolve early warnings and bottleneck problems with
executive correspondence.
B. Office of Biomedical Advance Research and Development Authority
(ANB). The Office of Biomedical Advanced Research and Development
Authority (BARDA), established in April 2007 in response to the
Pandemic and All-Hazards Preparedness Act of 2006, serves preparedness
and response roles to provide medical countermeasures (MCM) in order to
mitigate the medical consequences of chemical, biological,
radiological, and nuclear (CBRN) threats and agents and emerging
infectious diseases, including pandemic influenza. BARDA executes this
mission by facilitating research, development, innovation, and
acquisition of medical countermeasures and expanding domestic
manufacturing infrastructure and surge capacity of these medical
countermeasures.
BARDA is headed by a Deputy Assistant Secretary, and includes the
following components:
Division of Influenza (ANB1)
Division of Emerging Infectious Diseases (ANB2)
Division of Chemical, Biological, Radiological and Nuclear
Threats (ANB3)
Division of Strategic Science and Technology (ANB4)
Division of Regulatory and Quality Affairs (ANB5)
C. Office of Preparedness and Emergency Operations (ANC). The
Office of Preparedness and Emergency Operations (OPEO) is responsible
for providing a well-integrated infrastructure that supports the
Department's capabilities to prevent, prepare for, respond to and
recover from natural public health and medical threats and emergencies.
OPEO leads the preparedness and response activities required to
coordinate public health and medical response systems and activities
with relevant Federal, state, Tribal, Territorial, local, and
international communities under ESF 8, ESF 6 and ESF 14 of the NRF.
OPEO is also responsible for the HHS Continuity of Operations (COOP)
and the development of the ASPR COOP Plan.
The Office of Preparedness and Emergency Operations (OPEO) is
headed by a Deputy Assistant Secretary, and includes the following
components:
Division of Mass Care (ANC1)
Division of Operations (ANC2)
Division of Planning (ANC3)
Division of Infrastructure Coordination (ANC4)
Division of Emergency Care Coordination Center (ECCC)
(ANC5)
Division of National Disaster Medical System (NDMS) (ANC6)
D. Office of Acquisitions Management, Contracts and Grants (AND).
The Office of Acquisitions Management, Contracts and Grants (AMCG)
provides ASPR with acquisition support to prepare and respond to the
adverse health emergencies and disasters and provides contractual
support to the Immediate Office of the ASPR, BARDA, Office of Policy
and Planning (OPP), and Office of Financial Planning and Analysis
(FPA). The office focuses on providing acquisition and contractual
support to BARDA in two specific program divisions: Chemical,
Biological, Radiological, and Nuclear Threats (CBRNT) and Influenza
(Flu). The Division of Acquisition Programs Support (APS) provides a
wide range of program management support to the ASPR as well as direct
program support to the following BARDA divisions--CBRN, Influenza,
Emerging Infectious Diseases, and Strategic Science and Technology.
Functional support activities of the Office include requirements
analysis for statement of work/statement of operations development,
acquisition strategy development and tracking assistance to include
contractual milestone development with measurable success criteria. The
office also serves as ASPR's focal point for management, leadership and
administration of discretionary and mandatory grants and cooperative
agreements.
The Office of Acquisitions Management, Contracts and Grants (AMCG)
is headed by a Director, and includes the following components:
Division of ASPR Support (AND1)
Division of BARDA Support (AND2)
Division of Acquisition Programs Support (AND3)
Division of Grants Management (AND4)
Division of Acquisition Policy (AND5)
E. Office of Policy and Planning (ANE). The Office of Policy and
Planning (OPP) is responsible for policy development, analysis and
coordination, research and evaluation, and strategic planning. The OPP:
(1) Analyzes proposed policies, Presidential Directives, and
regulations, and develops short- and long-term policy objectives for
ASPR; (2) leads the development and implementation of an integrated
ASPR approach to policy; (3) serves as the focal point for the Homeland
Security Council (HSC) and the National Security Council (NSC) policy
coordination activities on behalf of ASPR and represents the ASPR, as
appropriate, in interagency policy coordination meetings and
activities; (4) undertakes studies of preparedness and response issues,
identifying gaps in policy, and initiating policy planning and
formulation to fill these gaps; (5) leads in the implementation of the
PAHPA and is responsible for developing the quadrennial National Health
Security Strategy and implementation plan for public health emergency
preparedness and response; (6) develops strategic partnerships with
stakeholders and leads in the development of ASPR strategies for
knowledge and information management; (7) manages the development of
the ASPR strategic plan, annual plan, and balanced scorecard, and
compiles the ASPR Organizational Assessment by tracking Key Performance
Indicators as part of the ASPR strategic management system; (8)
develops and maintains liaison relationships with strategic planning
personnel of HHS and ESF 8 partner organizations; and (9) manages
strategic planning program objectives to ensure programs are consistent
with ASPR goals and monitors program development to make sure that
timelines are met accordingly.
OPP is headed by a Deputy Assistant Secretary and includes the
following components:
Division of Policy and Strategic Planning (ANE1)
Division of Medical Countermeasures Policy and Planning
(ANE2)
Division of Health Systems Policy (ANE3)
Division of International Health (ANE4)
Division of Biosecurity/Biosafety/Countering Biologic
Threats (ANE5)
F. Office of Financial Planning and Analysis (ANF). The Office of
Financial Planning and Analysis (OFPA) ensures that ASPR's financial
resources are aligned to its strategic priorities. OFPA carries out its
responsibilities by
[[Page 35038]]
formulating, monitoring, and evaluating ASPR budgets and financial
plans that support program activities and ensures the effective and
efficient execution of ASPR financial resources. OFPA has
administrative oversight of the Administration & Finance section of the
emergency management group that is activated under ESF 8 of the NRF
during a public health emergency. On behalf of the ASPR, OFPA serves as
the primary point of contact with the Office of the Assistant Secretary
for Financial Resources, the Office of Management and Budget (OMB) and
Congressional Appropriation Committees. In compliance with OMB Circular
A-123, FPA ensures accountability and effectiveness of ASPR's financial
programs and operations by establishing, assessing, correcting, and
reporting on internal controls.
The Office of Financial Planning and Analysis is headed by a
Director and includes the following components:
Division of Budget Formulation and Execution (ANF1)
Division of Requisition Services (ANF2)
Division of Management Assurance (ANF3)
Division of Administration and Finance (ANF4)
II. Delegations of Authority. All delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegation, provided they are consistent with this reorganization.
Dated: June 14, 2010.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2010-14997 Filed 6-18-10; 8:45 am]
BILLING CODE 4150-37-P
