2024-30333. Statement of Organization, Functions, and Delegations of Authority

Document Headings

Document headings vary by document type but may contain the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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. ( print 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.