[Federal Register Volume 89, Number 32 (Thursday, February 15, 2024)]
[Notices]
[Pages 11837-11838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
    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