Statement of Organization, Functions, and Delegations of Authority, 11837-11838 [2024-02603]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices
Investigational Drugs Under an IND:
Questions and Answers.’’ FDA issued a
revised draft guidance of the same title
in August 2022 to include responses to
stakeholder questions received since
publication of the final guidance in
2016. This guidance finalizes the
revised draft guidance issued on August
23, 2022 (87 FR 51679). FDA considered
comments received on the revised draft
guidance as the guidance was finalized.
Changes from the revised draft to the
final guidance address the inclusion of
information about charging for
investigational drugs in the informed
consent document and provide the
definition of intermediate-size patient
population expanded access. In
addition, editorial changes were made
to improve clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Charging for
Investigational Drugs Under an IND:
Questions and Answers.’’ 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: February 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–03186 Filed 2–14–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:36 Feb 14, 2024
Jkt 262001
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.
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:
SUMMARY:
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
11837
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
E:\FR\FM\15FEN1.SGM
15FEN1
khammond on DSKJM1Z7X2PROD with NOTICES
11838
Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices
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)
VerDate Sep<11>2014
18:36 Feb 14, 2024
Jkt 262001
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)
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; DATA 2000 Waiver Training
Payment Program Application for
Payment, OMB No. 0906–0061
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
