Notice2023-17379
Statement of Organization, Functions, and Delegations of Authority
Primary source
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Published
August 14, 2023
Effective
August 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST) has modified its organizational structure.
Full Text
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<title>Federal Register, Volume 88 Issue 155 (Monday, August 14, 2023)</title>
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[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55053-55054]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17379]
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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 (FDA), Center for Devices and
Radiological Health (CDRH), Office of Strategic Partnerships and
Technology Innovation (OST) has modified its organizational structure.
DATES: These new organizations' structures were approved by the
Secretary of Health and Human Services on June 27, 2023, and effective
on August 8, 2023.
FOR FURTHER INFORMATION CONTACT: Denise Huttenlocker, Associate
Director for Management, Office of Management, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 240-743-1760.
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 amended to reflect Food and
Drug Administration's reorganization of CDRH, OST.
This reorganization changed the OST organizational structure from
an office with three divisions to an office with five suboffices each
with their own divisions. The previous divisions were: the Division of
All Hazards Response, Science and Strategic Partnerships, the Division
of Digital Health, and the Division of Technology and Data Services.
The OST will elevate the programs performed by these former divisions
to a super office structure whereby these divisions are abolished, and
their functions and resources are realigned across five new OST
suboffices. DCCC. ORGANIZATION. The Office of Office of Strategic
Partnerships and Technology Innovation is headed by the Director of
Strategic Partnerships and Technology Innovation and includes the
following organizational units:
Office of Readiness and Response
Division of All Hazards Preparedness and Response
Division of Standards and Conformity Assessment
Division of Medical Device Cybersecurity
Office of Equity and Innovative Development
Division of Patient-Centered Development
Division of Heath Equity
Division of Partnerships and Innovation
Digital Health Center of Excellence
Division of Digital Health Policy
Division of Digital Health Technology Assessment
Division of Digital Health Outreach
Office of Technology and Data Services
Division of Business Transformation Delivery
Division of Technology Services
Division of Data Services
Office of Supply Chain Resilience
Division of Prevention, Innovation, and Resilience
Division of Shortage Assessment and Product Authentication
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
[[Page 55054]]
complete SMG can find it on FDA's website at: <a href="http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm">http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm</a>.
(Authority: 44 U.S.C. 3101.)
Dated: August 9, 2023.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023-17379 Filed 8-11-23; 8:45 am]
BILLING CODE 4164-01-P
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