Notice2024-02603
Statement of Organization, Functions, and Delegations of Authority
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 15, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration's (FDA), Office of the Commissioner (OC), Office of Digital Transformation (ODT) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on December 21, 2023.
Full Text
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<title>Federal Register, Volume 89 Issue 32 (Thursday, February 15, 2024)</title>
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[Federal Register Volume 89, Number 32 (Thursday, February 15, 2024)]
[Notices]
[Pages 11837-11838]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA), Office of the
Commissioner (OC), Office of Digital Transformation (ODT) has modified
their organizational structure. The new organizational structure was
approved by the Secretary of Health and Human Services on December 21,
2023.
FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk Management; Office of Finance, Budget,
Acquisitions, and Planning; 4041 Powder Mill Road, Beltsville, MD
20705-4304; 301-796-3843.
SUPPLEMENTARY INFORMATION:
I. Introduction
Part D, Chapter D-B, (Food and Drug Administration), the Statement
of Organization, Functions and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970,
60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28,
2011, and 84 FR 22854, May 20, 2019) is revised to reflect the FDA,
OC's ODT.
The proposed changes to ODT's organizational structure consolidate
similar functions and resources across multiple areas and align the
organizational structure with federal and industry standards. This will
create a more agile organization, improve resource management, enhance
customer service, and better align the name of organizational
components with current functions. The reorganization will maintain a
reasonable span of control and clear and appropriate lines of authority
and responsibilities between organizations. This will also ensure
optimal resource utilization and leveraging of existing staff talent
and will allow ODT more efficiency and effectiveness in the advancement
of continuous improvement efforts.
This reorganization elevates the functions and resources of the
Office of Enterprise Portfolio Management in the Office of Information
Management and Technology (OIMT) to the Office of Digital
Transformation; established the Division of Acquisition Innovation,
Division of Technology Business Management, and the Division of Finance
and Budget within OEPM; and realigned the Delivery Management Support
Staff from the Office of Technology and Delivery (OTD) to OEPM,
Division of Acquisition Innovation; established the Acquisitions
Operations Branch, Acquisition Governance Branch, and IT Asset
Management Branch within the Division of Acquisition Innovation;
established the IT Governance Branch and Business Intelligence Branch
within the Division of Technology Business Management; establish the
Budget Formulation Branch and Budget Execution Branch within the
Division of Finance and Budget; established the Office of
Organizational Excellence (OEX) reporting to the ODT; established the
Division of People and Culture (DPC) and the Division of Knowledge and
Communications (DKC) within OEX; realigned the staff resources and
functions from the OBCA Division of Management Services (DMS) to DPC in
OEX; established the Talent Strategy Staff (TSS) and the Executive
Services Staff (ESS) within OEX; abolished the Strategic Operations
Staff (SOS) located in ODT Immediate Office and realigned staff
resources and functions to DKC in OEX; realigned staff resources and
functions from the Knowledge Management Staff (KMS) in the Office of
Data, Analytics, and Research to DKC; realigned existing executive
services functions and staff in the ODAR, OIMT, and ODT immediate
offices to DKC; retitled the current Office of Business and Customer
Assurance in OIMT to the Office of Customer Experience (OCX); abolished
the Division of Management Services and Division of Business
Partnerships and Support in the current Office of Business and Customer
Assurance; established the Division of Collaboration Services, Division
of Service Desk and Support, Division of Endpoint Management, Division
of End User Services, and Division of Employee Information in the new
OCX; established the Enterprise Architecture Staff in the OIMT
Immediate Office; established the Division of Engineering (DE) in the
OIMT Office of Technology and Delivery; established the Engineering
Branch, Implementation Branch, Application Branch, and Database &
Content Services Branch within DE; retitled the Division of
Infrastructure Operations (DIO) in the OTD in OIMT to the Division of
Infrastructure Services (DIS); abolished the Infrastructure Management
Services Staff (IMSS) within DIO and realigned
[[Page 11838]]
the staff resources and functions to the DIS immediate office;
abolished the DIO's Implementation Branch, Infrastructure Engineering
Branch, System Operations Branch, Network and Communications Operations
Branch, Systems Monitoring and Response Branch, and Systems Monitoring
and Response Branch; established the Network Services Branch, Systems
Services Branch, and Operations Branch in DIS; realigned staff
resources based on their roles and responsibilities; abolished the
Delivery Management Support Staff (DMSS) within OTD immediate office;
abolished the Application Management Services Staff, Medical Products
Branch, OC/CVM/CTP Branch, ORA/CFSAN/CVM Branch, Enterprise
Applications Branch, Data Management and Operations Branch within OIMT/
OTD/Division of Application Services (DAS); established the Regulatory
Operations Branch, Scientific Operations Branch, and Business & Post-
Market Branch within DAS; retitled the Office of Data, Analytics, and
Research (ODAR), Data Staff to the Analytics Staff; retitled the ODAR
Health Informatics Staff to the Informatics Staff; established the Data
and Analytics Governance Staff and Data Strategy and Services Staff
within ODAR; abolished the Knowledge Management Staff (KMS) within ODAR
and realigned the staff resources and functions to the Office of
Organizational Excellence, Division of Knowledge & Communications;
established the Division of Cybersecurity Capabilities (DCC), Division
of Risk & Compliance (DRC), Division of Cybersecurity Operations (DCO),
and the Division of Counterintelligence & Insider Threat (DCIT) within
the Office of Information Security (OIS); established the Vulnerability
Management Branch and Identity Management Branch under OIS/DCC;
established the Information System Security Branch and Risk Compliance
and Audit Branch under OIS/DRMC; established the CIOCC Operations
Branch and Network Security Branch under OIS/DCO; established the
Program Staff within the OIS immediate office; realigned OIS staff
resources and functions within OIS based on their roles and
responsibilities.
The Food and Drug Administration Office of the Commissioner's
Office of Digital Transformation is headed by the Chief Information
Officer and has been restructured as follows:
Office of Digital Transformation (DCAD)
Office of Information Management and Technology (DCADA)
Enterprise Architecture Staff (DCADA1)
Office of Technology and Delivery (DCADAA)
Division of Infrastructure Services (DCADAAA)
Network Services Branch (DCADAAA1)
Systems Services Branch (DCADAAA2)
Operations Branch (DCADAAA3)
Division of Application Services (DCADAAB)
Regulatory Operations Branch (DCADAAB1)
Scientific Operations Branch (DCADAAB2)
Business and Post-Market Branch (DCADAAB3)
Division of Engineering (DCADAAC)
Engineering Branch (DCADAAC1)
Implementation Branch (DCADAAC2)
Application Branch (DCADAAC3)
Database & Content Services Branch (DCADAAC4)
Office of Customer Experience (DCADAB)
Division of Collaboration Services (DCADABA)
Division of Service Desk and Support (DCADABB)
Division of Endpoint Management (DCADABC)
Division of End User Services (DCADABD)
Division of Employee Information (DCADABE)
Office of Information Security (DCADB)
Program Staff (DCADB1)
Division of Cybersecurity Capabilities (DCADBA)
Vulnerability Management Branch (DCADBA1)
Identity Management Branch (DCADBA2)
Division of Risk and Compliance (DCADBB)
Information System Security Branch (DCADBB1)
Risk Compliance and Audit Branch (DCADBB2)
Division of Cybersecurity Operations (DCADBC)
CIOCC Operations Branch (DCADBC1)
Network Security Branch (DCADBC2)
Division of Counterintelligence/Insider Threat (DCADBD)
Office of Data, Analytics, and Research (DCADC)
Analytics Staff (DCADC1)
Informatics Staff (DCADC2)
Data and Analytics Governance Staff (DCADC4)
Data Strategy and Services Staff (DCADC5)
Office of Enterprise Portfolio Management (DCADD)
Division of Acquisition Innovation (DCADDA)
Acquisitions Operations Branch (DCADDA1)
Acquisitions Governance Branch (DCADDA2)
IT Asset Management Branch (DCADDA3)
Division of Technology Business Management (DCADDB)
IT Governance Branch (DCADDB1)
Business Intelligence Branch (DCADDB2)
Division of Finance and Budget (DCADDC)
Budget Formulation Branch (DCADDC1)
Budget Execution Branch (DCADDC2)
Office of Organizational Excellence (DCADE)
Talent Strategy Staff (DCADE1)
Executive Services Staff (DCADE2)
Division of People and Culture (DCADEA)
Employee Experience Branch (DCADEA1)
Learning and Development Branch (DCADEA2)
Division of Knowledge and Communications (DCADEB)
Knowledge and Innovation Branch (DCADEB1)
Communications and Outreach Branch (DCADEB2)
II. Delegations of Authority
Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, all delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.
III. Electronic Access
This reorganization is reflected in FDA's Staff Manual Guide (SMG).
Persons interested in seeing the complete Staff Manual Guide can find
it on FDA's website at: <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm</a>.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2024-02603 Filed 2-14-24; 8:45 am]
BILLING CODE 4164-01-P
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