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[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Notices]
[Pages 104549-104550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30333]

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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), Center for Drug 
Evaluation and Research (CDER), Office of Medical Policy (OMP) has 
modified their organizational structure. The new organizational 
structure was approved by the Secretary of Health and Human Services on 
November 19, 2024.

FOR FURTHER INFORMATION CONTACT: Jennifer Wade, Acting Director, 
Division of Reorganizations and Delegations of Authority, Office of 
Budget, Office of Finance, Budget, and Acquisitions, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
731-0192.

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's 
reorganization of the CDER, OMP.

[[Page 104550]]

    The reorganization will improve FDA's ability to carry out its 
public health mission by realigning and dedicating resources within the 
organization to modernize clinical trials. The clinical trial 
innovation work tracks will place DCI at the forefront to robustly meet 
policy development, implementation, and analysis needs in areas such as 
Artificial Intelligence (AI), Digital Health Technologies (DHTs), Real-
World Evidence (RWE), and other rapidly advancing sectors in the 
dynamic clinical trial ecosystem.
    The CDER, OMP, Office of Medical Policy Initiatives retitled the 
Division of Clinical Trial Quality to the Division of Clinical 
Innovations.
    The reorganization will enhance the office's ability to attract and 
retain a diverse workforce representative of our nation and bring like 
scientists and policy experts together from across the organization, 
thereby facilitating collaboration and efficient use of shared 
resources while advancing key innovations in drug development. By 
developing responsive policies, the Division of Clinical Innovations 
will modernize the policy environment to ensure that CDER is providing 
the needed regulatory perspective to guide the appropriate use of such 
tools and technologies.
    The FDA's CDER, OMP has been restructured as follows:
    DCDH ORGANIZATION. The CDER OMP (DCDH) is headed by the Director, 
OMP and includes the following:

Office of Medical Policy (DCDH)
Office of Prescription Drug Promotion (DCDHA)
Division of Advertising and Promotion Review II (DCDHAA)
Division of Advertising and Promotion Review I (DCDHAB)
Division of Promotion Policy, Research and Operations (DCDHAC)
Office of Medical Policy Initiatives (DCDHB)
Division of Medical Policy Development (DCDHBA)
Division of Medical Policy Programs (DCDHBB)
Division of Clinical Innovations (DCDHBC)

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. 2024-30333 Filed 12-20-24; 8:45 am]
BILLING CODE 4164-01-P
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