88 FR 155 pgs. 55053-55054 - Statement of Organization, Functions, and Delegations of Authority
Type: NOTICEVolume: 88Number: 155Pages: 55053 - 55054
Pages: 55053, 55054FR document: [FR Doc. 2023-17379 Filed 8-11-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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
[top] This reorganization is reflected in FDA's Staff Manual Guide (SMG). Persons interested in seeing the
(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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