Office of the Assistant Secretary for Preparedness and Response; Statement of Organization, Functions and Delegations of Authority, 33941-33942 [2018-15310]
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submission. You should submit two
copies total. One copy will include the
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the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Metal Expandable
Biliary Stents—Premarket Notification
(510(k)) Submissions’’ to the Office of
the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
April Marrone, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
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33941
Ave., Bldg. 66, Rm. G218, Silver Spring,
MD 20993–0002, 240–402–6510.
SUPPLEMENTARY INFORMATION:
number 1500070 to identify the
guidance you are requesting.
I. Background
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E, have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
parts 50 and 56 have been approved
under OMB control number 0910–0755;
the collections of information in 21 CFR
56.115 have been approved under OMB
control number 0910–0130; the
collections of information in 21 CFR
50.23 have been approved under OMB
control number 0910–0586; and the
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485.
This draft guidance provides draft
recommendations for 510(k)
submissions for metal expandable
biliary stents and their associated
delivery systems. These devices are
intended to provide luminal patency of
malignant strictures in the biliary tree.
FDA is updating this guidance to reflect
current review practices. The scope of
this guidance is limited to metal
expandable biliary stents regulated
under 21 CFR 876.5010 (Biliary catheter
and accessories) and with product code
FGE (Catheter, Biliary, Diagnostic). This
draft guidance applies only to biliary
stents indicated for palliation of
malignant strictures in the biliary tree.
It does not apply to biliary stents
indicated to treat benign strictures or
stents intended to be used in the
vasculature, tracheal/bronchial tubes, or
other gastrointestinal anatomy. This
draft guidance, when final, will
supersede the guidance ‘‘Guidance for
the Content of Premarket Notifications
for Metal Expandable Biliary Stents,’’
issued on February 5, 1998.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Metal Expandable Biliary Stents—
Premarket Notification (510(k))
Submissions.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
IV. Paperwork Reduction Act of 1995
Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15294 Filed 7–17–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Office of the Secretary
III. Electronic Access
Office of the Assistant Secretary for
Preparedness and Response;
Statement of Organization, Functions
and Delegations of Authority
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
draft guidance is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Metal Expandable Biliary Stents—
Premarket Notification (510(k))
Submissions’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
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 the Assistant
Secretary for Preparedness and
Response (ASPR), as last amended at 79
FR 70.535 (Nov. 26, 2014), 78 FR 25277
(April 30, 2013), 78 FR 7784 (Feb. 4,
2013), 75 FR 35.035 (June 21, 2010) to
realign the functions of ASPR to reflect
the changes mandated by the 21st
Century Cures Act and to address everincreasing manmade and naturally
occurring threats which degrade public
health, access to healthcare, access to
emergency medical services and
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33942
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
national security. The changes are as
follows.
I. Under AN.10 Organization, delete
all of the components and replace with
the following:
A. Immediate Office of the Assistant
Secretary for Preparedness and
Response (ANA)
B. Office of Biomedical Advanced
Research and Development Authority
(ANB)
C. Office of the Principal Deputy
Assistant Secretary (ANC)
D. Office of the Deputy Assistant
Secretary Incident Command and
Control (ANG)
II. Delete AN.20 Functions, in its
entirety and replace with the following:
Section AR.20 Functions.
A. Immediate Office of the Assistant
Secretary for Preparedness and
Response: The Immediate Office of the
Assistant Secretary for Preparedness
and Response (IO/ASPR) is headed by
the Assistant Secretary, who provides
leadership and executive and strategic
direction for the ASPR organization.
The Assistant Secretary is the principal
advisor to the Secretary on all matters
related to Federal public health and
medical preparedness and response for
public health emergencies. The
Assistant Secretary is responsible for
carrying out ASPR’s mission and
implementing the functions of ASPR.
The IO/ASPR (1) ensures development
and maintenance of liaison
relationships with HHS operating and
staff divisions and represents HHS at
interagency meetings, as required; (2)
establishes and maintains effective
communications and outreach guidance
and support for all external
communications, including legislative
and executive branch questions and
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
section 2811 and other relevant sections
of the Public Health Service Act, as
amended; (3) oversees advanced
research, development and procurement
of qualified countermeasures, security
countermeasures and qualified
pandemic or epidemic products; (4)
coordinate with relevant federal officials
to ensure integration of federal
preparedness and response activities for
public health emergencies; (5) manages
correspondence control for the Assistant
Secretary; and (6) coordinates the
strategic and operational activities for
public health preparedness response
and recovery.
B. Office of Biomedical Advance
Research and Development Authority
(ANB). The Office of Biomedical
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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 MCM and expanding
domestic manufacturing infrastructure
and surge capacity of these MCM.
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)
• Division of Research, Innovation and
Ventures (ANB6)
C. Office of the Principal Deputy
Assistant Secretary (ANC). The Office of
the Principal Deputy Assistant Secretary
(OPDAS) 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.
OPDAS leads the preparedness and
response activities required to
coordinate public health and healthcare
response systems and activities with
relevant federal, state, tribal, territorial,
local, and international communities
under the National Response
Framework and Emergency Support
Annexes #8, #6 and #14. OPDAS is
responsible for the execution of
business management operations and
managing coordination. OPDAS
provides for the facility, logistics,
information technology and
infrastructure support services
necessary to maintain day-to-day
operations of ASPR, including functions
of Human Resources, Organization and
Employee Development, Ethics, United
States Public Health Service (USPHS)
liaison, acquisitions management,
contracts, grants, and all financial
planning and analysis.
The Office of the Principal Deputy
Assistant Secretary is headed by the
Principal Deputy Assistant Secretary,
and includes the following components:
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• Division of Management Finance and
Human Capital (ANC1)
• Division of Emergency Management
and Medical Operations (ANC2)
• Division of Resource Management
(ANC3)
D. Deputy Assistant Secretary
Incident Command and Control (ANG):
The Deputy Assistant Secretary (DAS/
ICC) is responsible for the policy
development, planning analysis,
requirements and strategic planning.
DAS/ICC manages and operates the HHS
Secretary’s Operation Center (SOC),
intelligence, security, information
management and is also responsible for
the HHS Continuity of Operations
(COOP) and the development of the
ASPR COOP Plan. The Office of the
Assistant Secretary Incident Command
and Control (DAS/ICC) is headed by the
Deputy Assistant Secretary Incident
Command and Control, and includes the
following components:
• Division of Security Intelligence and
Information Management
• Division of Strategy, Policy, Planning
and Requirements
III. 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.
Alex M. Azar II,
Secretary.
[FR Doc. 2018–15310 Filed 7–17–18; 8:45 am]
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[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33941-33942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15310]
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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 the
Assistant Secretary for Preparedness and Response (ASPR), as last
amended at 79 FR 70.535 (Nov. 26, 2014), 78 FR 25277 (April 30, 2013),
78 FR 7784 (Feb. 4, 2013), 75 FR 35.035 (June 21, 2010) to realign the
functions of ASPR to reflect the changes mandated by the 21st Century
Cures Act and to address ever-increasing manmade and naturally
occurring threats which degrade public health, access to healthcare,
access to emergency medical services and
[[Page 33942]]
national security. The changes are as follows.
I. Under AN.10 Organization, delete all of the components and
replace with the following:
A. Immediate Office of the Assistant Secretary for Preparedness and
Response (ANA)
B. Office of Biomedical Advanced Research and Development Authority
(ANB)
C. Office of the Principal Deputy Assistant Secretary (ANC)
D. Office of the Deputy Assistant Secretary Incident Command and
Control (ANG)
II. Delete AN.20 Functions, in its entirety and replace with the
following:
Section AR.20 Functions.
A. Immediate Office of the Assistant Secretary for Preparedness and
Response: The Immediate Office of the Assistant Secretary for
Preparedness and Response (IO/ASPR) is headed by the Assistant
Secretary, who provides leadership and executive and strategic
direction for the ASPR organization. The Assistant Secretary is the
principal advisor to the Secretary on all matters related to Federal
public health and medical preparedness and response for public health
emergencies. The Assistant Secretary is responsible for carrying out
ASPR's mission and implementing the functions of ASPR. The IO/ASPR (1)
ensures development and maintenance of liaison relationships with HHS
operating and staff divisions and represents HHS at interagency
meetings, as required; (2) establishes and maintains effective
communications and outreach guidance and support for all external
communications, including legislative and executive branch questions
and 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 section 2811 and other relevant sections of the Public
Health Service Act, as amended; (3) oversees advanced research,
development and procurement of qualified countermeasures, security
countermeasures and qualified pandemic or epidemic products; (4)
coordinate with relevant federal officials to ensure integration of
federal preparedness and response activities for public health
emergencies; (5) manages correspondence control for the Assistant
Secretary; and (6) coordinates the strategic and operational activities
for public health preparedness response and recovery.
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 MCM and expanding domestic manufacturing infrastructure
and surge capacity of these MCM.
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)
Division of Research, Innovation and Ventures (ANB6)
C. Office of the Principal Deputy Assistant Secretary (ANC). The
Office of the Principal Deputy Assistant Secretary (OPDAS) 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. OPDAS leads the preparedness and response activities
required to coordinate public health and healthcare response systems
and activities with relevant federal, state, tribal, territorial,
local, and international communities under the National Response
Framework and Emergency Support Annexes #8, #6 and #14. OPDAS is
responsible for the execution of business management operations and
managing coordination. OPDAS provides for the facility, logistics,
information technology and infrastructure support services necessary to
maintain day-to-day operations of ASPR, including functions of Human
Resources, Organization and Employee Development, Ethics, United States
Public Health Service (USPHS) liaison, acquisitions management,
contracts, grants, and all financial planning and analysis.
The Office of the Principal Deputy Assistant Secretary is headed by
the Principal Deputy Assistant Secretary, and includes the following
components:
Division of Management Finance and Human Capital (ANC1)
Division of Emergency Management and Medical Operations (ANC2)
Division of Resource Management (ANC3)
D. Deputy Assistant Secretary Incident Command and Control (ANG):
The Deputy Assistant Secretary (DAS/ICC) is responsible for the policy
development, planning analysis, requirements and strategic planning.
DAS/ICC manages and operates the HHS Secretary's Operation Center
(SOC), intelligence, security, information management and is also
responsible for the HHS Continuity of Operations (COOP) and the
development of the ASPR COOP Plan. The Office of the Assistant
Secretary Incident Command and Control (DAS/ICC) is headed by the
Deputy Assistant Secretary Incident Command and Control, and includes
the following components:
Division of Security Intelligence and Information Management
Division of Strategy, Policy, Planning and Requirements
III. 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.
Alex M. Azar II,
Secretary.
[FR Doc. 2018-15310 Filed 7-17-18; 8:45 am]
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