83 FR 33941 - Office of the Assistant Secretary for Preparedness and Response; Statement of Organization, Functions and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 83, Issue 138 (July 18, 2018)
Office of the Secretary
Federal Register Volume 83, Issue 138 (July 18, 2018)
| Page Range | 33941-33942 | |
| FR Document | 2018-15310 |
[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)] [Notices] [Pages 33941-33942] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15310] ----------------------------------------------------------------------- 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] BILLING CODE P
![Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33941
submission. You should submit two Ave., Bldg. 66, Rm. G218, Silver Spring, number 1500070 to identify the
copies total. One copy will include the MD 20993–0002, 240–402–6510. guidance you are requesting.
information you claim to be confidential SUPPLEMENTARY INFORMATION: IV. Paperwork Reduction Act of 1995
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS I. Background This draft guidance refers to
CONFIDENTIAL INFORMATION.’’ The This draft guidance provides draft previously approved collections of
Agency will review this copy, including recommendations for 510(k) information found in FDA regulations.
the claimed confidential information, in submissions for metal expandable These collections of information are
its consideration of comments. The biliary stents and their associated subject to review by the Office of
second copy, which will have the delivery systems. These devices are Management and Budget (OMB) under
claimed confidential information intended to provide luminal patency of the Paperwork Reduction Act of 1995
redacted/blacked out, will be available malignant strictures in the biliary tree. (44 U.S.C. 3501–3520). The collections
for public viewing and posted on FDA is updating this guidance to reflect of information in 21 CFR part 807,
https://www.regulations.gov. Submit current review practices. The scope of subpart E, have been approved under
both copies to the Dockets Management this guidance is limited to metal OMB control number 0910–0120; the
Staff. If you do not wish your name and expandable biliary stents regulated collections of information in 21 CFR
contact information to be made publicly under 21 CFR 876.5010 (Biliary catheter part 820 have been approved under
available, you can provide this and accessories) and with product code OMB control number 0910–0073; the
information on the cover sheet and not FGE (Catheter, Biliary, Diagnostic). This collections of information in 21 CFR
in the body of your comments and you draft guidance applies only to biliary part 812 have been approved under
must identify this information as stents indicated for palliation of OMB control number 0910–0078; the
‘‘confidential.’’ Any information marked malignant strictures in the biliary tree. collections of information in 21 CFR
as ‘‘confidential’’ will not be disclosed It does not apply to biliary stents parts 50 and 56 have been approved
except in accordance with 21 CFR 10.20 indicated to treat benign strictures or under OMB control number 0910–0755;
and other applicable disclosure law. For stents intended to be used in the the collections of information in 21 CFR
more information about FDA’s posting vasculature, tracheal/bronchial tubes, or 56.115 have been approved under OMB
of comments to public dockets, see 80 other gastrointestinal anatomy. This control number 0910–0130; the
FR 56469, September 18, 2015, or access draft guidance, when final, will collections of information in 21 CFR
the information at: https://www.gpo.gov/ supersede the guidance ‘‘Guidance for 50.23 have been approved under OMB
fdsys/pkg/FR-2015-09-18/pdf/2015- the Content of Premarket Notifications control number 0910–0586; and the
23389.pdf. for Metal Expandable Biliary Stents,’’ collections of information in 21 CFR
Docket: For access to the docket to issued on February 5, 1998. part 801 have been approved under
read background documents or the OMB control number 0910–0485.
II. Significance of Guidance
electronic and written/paper comments Dated: July 12, 2018.
received, go to https:// This draft guidance is being issued Leslie Kux,
www.regulations.gov and insert the consistent with FDA’s good guidance
Associate Commissioner for Policy.
docket number, found in brackets in the practices regulation (21 CFR 10.115).
[FR Doc. 2018–15294 Filed 7–17–18; 8:45 am]
heading of this document, into the The draft guidance, when finalized, will
BILLING CODE 4164–01–P
‘‘Search’’ box and follow the prompts represent the current thinking of FDA
and/or go to the Dockets Management on ‘‘Metal Expandable Biliary Stents—
Staff, 5630 Fishers Lane, Rm. 1061, Premarket Notification (510(k))
DEPARTMENT OF HEALTH AND
Rockville, MD 20852. Submissions.’’ It does not establish any
HUMAN SERVICES
You may submit comments on any rights for any person and is not binding
guidance at any time (see 21 CFR on FDA or the public. You can use an Office of the Secretary
10.115(g)(5)). alternative approach if it satisfies the
requirements of the applicable statutes Office of the Assistant Secretary for
An electronic copy of the guidance
and regulations. This guidance is not Preparedness and Response;
document is available for download
subject to Executive Order 12866. Statement of Organization, Functions
from the internet. See the
SUPPLEMENTARY INFORMATION section for III. Electronic Access and Delegations of Authority
information on electronic access to the Persons interested in obtaining a copy Part A, Office of the Secretary,
guidance. Submit written requests for a of the draft guidance may do so by Statement of Organization, Functions,
single hard copy of the draft guidance downloading an electronic copy from and Delegations of Authority of the
document entitled ‘‘Metal Expandable the internet. A search capability for all Department of Health and Human
Biliary Stents—Premarket Notification Center for Devices and Radiological Services (HHS) is being amended at
(510(k)) Submissions’’ to the Office of Health guidance documents is available Chapter AN, Office of the Assistant
the Center Director, Guidance and at https://www.fda.gov/MedicalDevices/ Secretary for Preparedness and
Policy Development, Center for Devices DeviceRegulationandGuidance/ Response (ASPR), as last amended at 79
and Radiological Health, Food and Drug GuidanceDocuments/default.htm. This FR 70.535 (Nov. 26, 2014), 78 FR 25277
Administration, 10903 New Hampshire draft guidance is also available at (April 30, 2013), 78 FR 7784 (Feb. 4,
Ave., Bldg. 66, Rm. 5431, Silver Spring, https://www.regulations.gov. Persons 2013), 75 FR 35.035 (June 21, 2010) to
amozie on DSK3GDR082PROD with NOTICES1
MD 20993–0002. Send one self- unable to download an electronic copy realign the functions of ASPR to reflect
addressed adhesive label to assist that of ‘‘Metal Expandable Biliary Stents— the changes mandated by the 21st
office in processing your request. Premarket Notification (510(k)) Century Cures Act and to address ever-
FOR FURTHER INFORMATION CONTACT: Submissions’’ may send an email increasing manmade and naturally
April Marrone, Center for Devices and request to CDRH-Guidance@fda.hhs.gov occurring threats which degrade public
Radiological Health, Food and Drug to receive an electronic copy of the health, access to healthcare, access to
Administration, 10903 New Hampshire document. Please use the document 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 Advanced Research and Development • Division of Management Finance and
follows. Authority (BARDA), established in Human Capital (ANC1)
I. Under AN.10 Organization, delete April 2007 in response to the Pandemic • Division of Emergency Management
all of the components and replace with and All-Hazards Preparedness Act of and Medical Operations (ANC2)
the following: 2006, serves preparedness and response • Division of Resource Management
A. Immediate Office of the Assistant roles to provide medical (ANC3)
Secretary for Preparedness and countermeasures (MCM) in order to D. Deputy Assistant Secretary
Response (ANA) mitigate the medical consequences of Incident Command and Control (ANG):
B. Office of Biomedical Advanced chemical, biological, radiological, and The Deputy Assistant Secretary (DAS/
Research and Development Authority nuclear (CBRN) threats and agents and ICC) is responsible for the policy
(ANB) emerging infectious diseases, including development, planning analysis,
C. Office of the Principal Deputy pandemic influenza. BARDA executes requirements and strategic planning.
Assistant Secretary (ANC) this mission by facilitating research, DAS/ICC manages and operates the HHS
D. Office of the Deputy Assistant development, innovation, and Secretary’s Operation Center (SOC),
Secretary Incident Command and acquisition of MCM and expanding intelligence, security, information
Control (ANG) domestic manufacturing infrastructure management and is also responsible for
II. Delete AN.20 Functions, in its and surge capacity of these MCM. the HHS Continuity of Operations
entirety and replace with the following: BARDA is headed by a Deputy (COOP) and the development of the
Section AR.20 Functions. Assistant Secretary, and includes the ASPR COOP Plan. The Office of the
A. Immediate Office of the Assistant following components: Assistant Secretary Incident Command
Secretary for Preparedness and • Division of Influenza (ANB1) and Control (DAS/ICC) is headed by the
Response: The Immediate Office of the • Division of Emerging Infectious Deputy Assistant Secretary Incident
Assistant Secretary for Preparedness Diseases (ANB2) Command and Control, and includes the
and Response (IO/ASPR) is headed by • Division of Chemical, Biological, following components:
the Assistant Secretary, who provides Radiological and Nuclear Threats • Division of Security Intelligence and
leadership and executive and strategic (ANB3) Information Management
direction for the ASPR organization. • Division of Strategic Science and • Division of Strategy, Policy, Planning
The Assistant Secretary is the principal Technology (ANB4) and Requirements
advisor to the Secretary on all matters • Division of Regulatory and Quality III. Delegations of Authority. All
related to Federal public health and Affairs (ANB5) delegations and redelegations of
medical preparedness and response for • Division of Research, Innovation and authority made to officials and
public health emergencies. The Ventures (ANB6) employees of affected organizational
Assistant Secretary is responsible for C. Office of the Principal Deputy components will continue in them or
carrying out ASPR’s mission and Assistant Secretary (ANC). The Office of their successors pending further
implementing the functions of ASPR. the Principal Deputy Assistant Secretary redelegation, provided they are
The IO/ASPR (1) ensures development (OPDAS) is responsible for providing a consistent with this reorganization.
and maintenance of liaison well-integrated infrastructure that
relationships with HHS operating and supports the Department’s capabilities Alex M. Azar II,
staff divisions and represents HHS at to prevent, prepare for, respond to and Secretary.
interagency meetings, as required; (2) recover from natural public health and [FR Doc. 2018–15310 Filed 7–17–18; 8:45 am]
establishes and maintains effective medical threats and emergencies. BILLING CODE P
communications and outreach guidance OPDAS leads the preparedness and
and support for all external response activities required to
communications, including legislative coordinate public health and healthcare DEPARTMENT OF HEALTH AND
and executive branch questions and response systems and activities with HUMAN SERVICES
inquiries, and serves as the principal relevant federal, state, tribal, territorial,
advisor to the ASPR on all legislative local, and international communities National Institutes of Health
strategies to fulfill the Office of the under the National Response National Institute of Diabetes and
ASPR and the HHS mission under Framework and Emergency Support Digestive and Kidney Diseases; Notice
section 2811 and other relevant sections Annexes #8, #6 and #14. OPDAS is of Closed Meetings
of the Public Health Service Act, as responsible for the execution of
amended; (3) oversees advanced business management operations and Pursuant to section 10(d) of the
research, development and procurement managing coordination. OPDAS Federal Advisory Committee Act, as
of qualified countermeasures, security provides for the facility, logistics, amended, notice is hereby given of the
countermeasures and qualified information technology and following meetings.
pandemic or epidemic products; (4) infrastructure support services The meetings will be closed to the
coordinate with relevant federal officials necessary to maintain day-to-day public in accordance with the
to ensure integration of federal operations of ASPR, including functions provisions set forth in sections
preparedness and response activities for of Human Resources, Organization and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
public health emergencies; (5) manages Employee Development, Ethics, United as amended. The grant applications and
correspondence control for the Assistant States Public Health Service (USPHS) the discussions could disclose
amozie on DSK3GDR082PROD with NOTICES1
Secretary; and (6) coordinates the liaison, acquisitions management, confidential trade secrets or commercial
strategic and operational activities for contracts, grants, and all financial property such as patentable material,
public health preparedness response planning and analysis. and personal information concerning
and recovery. The Office of the Principal Deputy individuals associated with the grant
B. Office of Biomedical Advance Assistant Secretary is headed by the applications, the disclosure of which
Research and Development Authority Principal Deputy Assistant Secretary, would constitute a clearly unwarranted
(ANB). The Office of Biomedical and includes the following components: invasion of personal privacy.
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Document Created: 2018-11-06 10:24:35
Document Modified: 2018-11-06 10:24:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 33941 |
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