Document ID: FDA-2023-N-0009-0001
Agency: fda
Document Type: Notice
Title: Statement of Organization, Functions, and Delegations of Authority
Posted Date: 2023-08-14T04:00Z

[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55053-55054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

(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]
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