2021-28378. Statement of Organization, Functions, and Delegations of Authority

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration's (FDA), Center for Food Safety and Applied Nutrition (CFSAN), including its Office of the Center Director (OCD), has modified their organizational structure. The new organizational structure was approved by the Deputy Secretary of Health and Human Services and effective on November 24, 2021.

FOR FURTHER INFORMATION CONTACT:

Yashika Rahaman, Director, Office of Planning, Evaluation and Risk Management, Office of Finance, Budget, Acquisitions and Planning, FDA, 4041 Powder Mill Road, 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 revised to reflect FDA's reorganization of CFSAN to elevate its OCD's International Affairs Staff to the Office of International Engagement.

The primary purpose of this reorganization is to establish the Office of International Engagement (OIE) within CFSAN. With the establishment of OIE, the current structure of the International Affairs Staff (IAS) (currently under OCD) would dissolve and its resources and functions absorbed into OIE. OIE (currently IAS) would maintain its current roles and responsibilities as the Center's focal point for engaging in international activities.

The establishment of the proposed OIE aligns with broader organizational initiatives and priorities due to the establishment of the Office of Global Policy and Strategy (OGPS) and the Associate Commissioner for Imported Food Safety in the Office of Food Policy and Response (OFPR). OIE (currently IAS) has primary responsibility for the Center's coordination of international engagement for all its mission areas and coordinates with OGPS and OFPR daily. The establishment of OIE will streamline and improve work processes for better effectiveness and efficiency. All OIE work activities cut across Foods program offices and agency lines and requires central coordination and support, and OIE, by having more prominence as an Office in the Center, will enhance this effort. Additionally, the efficiencies gained by the reorganization aligns with HHS Strategic Goal 5: Promote Effective and Efficient Management and Stewardship; Strategic Objective 5.1: Ensure responsible financial management and Strategic Objective 5.2: Manage human capital to achieve the HHS mission.

The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Office of the Center Director and Office of International Engagement has been restructured as follows:

DCEA. ORGANIZATION. The Center for Food Safety and Applied Nutrition's, Office of the Center Director is headed by the Center Director and includes the following:

Office of the Center Director (DCEA)

DCEO. ORGANIZATION. The Center for Food Safety and Applied Nutrition's, Office International Engagement is headed by the Director, Office of International Engagement, and includes the following:

Public Health and Trade Staff (DCEO1)

Regulatory Cooperation and Partnerships Staff (DCEO2)

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.

Dated: October 22, 2021.

Andrea Palm,

Deputy Secretary of Health and Human Services.