Statement of Organization, Functions, and Delegations of Authority

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration's (FDA), Center for Veterinary Medicine's (CVM), Office of Management (OM) and Office of New Animal Drug Evaluation (ONADE) have modified their organizational structures. The new organizational structures were approved by the Secretary of Health and Human Services on July 22, 2024.

FOR FURTHER INFORMATION CONTACT:

Yashika Rahaman, Director, Office of Planning, Evaluation, and Risk Management, Office of Finance, Budget, Acquisitions, and Planning, Food and Drug Administration, 4041 Powder Mill Rd., Beltsville, MD 20705-4304, 301-796-3843.

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 the reorganization of CVM OM and ONADE.

The reorganization of OM merged the Budget Planning and Evaluation Staff (BPES) and the Program and Resource Management Staff (PRMS) and retitled the PRMS to the Financial Management Staff (FMS) and abolished BPES. The reorganization retitled ONADE to the Office of New Animal Product Evaluation (ONAPE), established the Regulatory Counsel Staff and the Administrative Staff, established branches within the Division of Food Animal Drugs, the Division of Companion Animal Drugs, the Division of Human Food Safety, the Division of Manufacturing Technologies, the Division of Business Information Science and Management, the Division of Animal Bioengineering and Cellular Therapies (DABCT), and the Division of Scientific Support (DSS). The reorganization retitled DABCT to the Division of Biotechnology and retitled DSS to the Division of Statistical and Biological Sciences. The reorganization established the Office of Generic Animal Drugs (OGAD), established the Business Management and Operations Staff and the Division of Manufacturing Technologies (DMT) under OGAD, realigned the Division of Generic Animal Drugs (DGAD) from ONADE to OGAD, and established branches under DGAD and DMT.

DCGB. ORGANIZATION. CVM's OM is headed by the Associate Director for Management, and includes the following:

Financial Management Staff (DCGB1)

Human Capital Management Staff (DCGB2)

Talent Development Staff (DCGB3)

Business Informatics Staff (DCGB5)

DCGC. ORGANIZATION. CVM's ONAPE is headed by the Director, and includes the following:

Office of New Animal Product Evaluation (DCGC)

Regulatory Counsel Staff (DCGC1)

Administrative Staff (DCGC2)

Division of Food Animal Drugs (DCGCA)

Food Animal Branch 1 (DCGCA1)

Food Animal Branch 2 (DCGCA2)

Division of Companion Animal Drugs (DCGCC)

Companion Animal Branch 1 (DCGCC1)

Companion Animal Branch 2 (DCGCC2)

Companion Animal Branch 3 (DCGCC3)

Division of Human Food Safety (DCGCD)

Human Food Safety Branch 1 (DCGCD1)

Human Food Safety Branch 2 (DCGCD2)

Division of Manufacturing Technologies (DCGCE)

Feed and Topical Branch (DCGCE1)

Sterile Drugs Branch (DCGCE2)

Biotherapeutics Branch (DCGCE3)

Chemotherapeutics Branch (DCGCE4)

Drug Substance Branch (DCGCE5)

Division of Statistical and Biological Sciences (DCGCF)

Environmental Branch (DCGCF1)

Biostatistics Branch 1 (DCGCF2)

Biostatistics Branch 2 (DCGCF3)

Clinical Pharmacology Branch (DCGCF4)

Division of Business Information Science and Management (DCGCH)

Business Informatics Branch (DCGCH1)

Quality Assurance Branch (DCGCH2)

Project Management Branch (DCGCH3)

Division of Biotechnology (DCGCI)

Animal Biotechnology Branch (DCGCI1)

Biologic Products Branch (DCGCI2)

DCGG. ORGANIZATION. CVM's OGAD is headed by the Director, and includes the following:

Office of Generic Animal Drugs (DCGG)

Business Management and Operations Staff (DCGG1)

Division of Generic Animal Drugs (DCGGA)

Generics Review Branch 1 (DCGGA1)

Generics Review Branch 2 (DCGGA2)

Generics Review Branch 3 (DCGGA3)

Generics Review Branch 4 (DCGGA4)

Generics Review Branch 5 (DCGGA5)

Division of Manufacturing Technologies (DCGGB)

Generic Drug Manufacturing Branch 1 (DCGGB1)

Generic Drug Manufacturing Branch 2 (DCGGB2)

Generic Drug Manufacturing Branch 3 (DCGGB3)

Generic Drug Substances and Facilities Assessment Branch (DCGGB4)

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 SMG can find it on FDA's website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm .

(Authority: 44 U.S.C. 3101)