2016-02444. Office of Foods and Veterinary Medicine; Center for Food Safety and Applied Nutrition; Statement of Organization, Functions, and Delegations of Authority

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

Statement of Organizations, Functions, and Delegations of Authority The Food and Drug Administration (FDA) is announcing that it has reorganized the Office of Foods and Veterinary Medicine (OFVM), Center for Food Safety and Applied Nutrition (CFSAN) by establishing the new Office of Dietary Supplement Programs (ODSP). ODSP will consist of the Evaluation and Research Staff and the Regulatory Implementation Staff. This reorganization resulted in the retitling of the OFVM, CFSAN, Office of Nutrition, Labeling and Dietary Supplements (ONLDS) to the Office of Nutrition and Food Labeling (ONFL), and the abolishment of the Division of Dietary Supplement Programs (DDSP) under ONLDS. This new organizational structure was approved by the Secretary of Health and Human Services on XXXXX and effective upon signature.

FOR FURTHER INFORMATION CONTACT:

Helio Chaves, Acting Associate Director for Management, Center for Food Safety and Applied Nutrition, Office of Foods and Veterinary Medicine, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2471.

I. Part D, Chapter D-B, (Food and Drug Administration), the Statement of Organization, Functions, and Delegations of Authority for the Department of Health Human Services (35 FR 3685, February 25, 1970; 60 FR 56605, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112, August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July 28, 2011) is amended to reflect the transfer of DDSP functions and personnel into ODSP to better align the mission and day-to-day activities of DDSP. The reorganization brings more prominence to dietary supplements, which is a noteworthy interest to Congress, increasing the ability to recruit resources and expertise to ODSP, and allowing for a more strategic approach in how ODSP resources are utilized. ODSP will focus on ensuring the integrity of product identity, enhancing Good Manufacturing Practices (GMP) compliance even further through more enforcement and more education, increased attention to products with acute health hazards, finding efficiencies in New Dietary Ingredient (NDI) review process, and greater attention to claim substantiation. This reorganization is explained in Staff Manual Guides 1230A.1, 1231.20, and 1231.21.

FDA, OVFM, CFSAN has been restructured as follows:

DJJH ORGANIZATION. CFSAN is headed by the Center Director and includes the following organizational units:

Center for Food Safety and Applied Nutrition (DJJH)

Office of the Center Director (DJJHA)

Office of Management (DJJHB)

Office of Analytics and Outreach (DJJHC)

Office of Food Safety (DJJHD)

Office of Cosmetics and Colors (DJJHE)

Office of Regulatory Science (DJJHF)

Office of Food Additive Safety (DJJHG)

Office of Compliance (DJJHH)

Office of Applied Research and Safety Assessment (DJJHI)

Office of Regulations, Policy and Social Sciences (DJJHJ)

Office of Nutrition and Food Labeling (DJJHK)

Office of Dietary Supplement Programs (DJJHL)

DJJHK ORGANIZATION. ONFL is headed by the Office Director and includes the following organizational units:

Office of Nutrition and Food Labeling (DJJHK)

Food Labeling and Standards Staff

Nutrition Programs Staff

DJJHL ORGANIZATION. ODSP is headed by the Office Director and includes the following organizational units:

Office of Dietary Supplement Programs (DJJHL)

Evaluation and Research Staff

Regulatory Implementation Staff

II. Delegations of Authority. Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and re-delegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further re-delegations, provided they are consistent with this reorganization.

III. Electronic Access. Persons interested in seeing the completed Staff Manual Guide can find it on FDA's Webs site at: http://www.fda.gov/​AboutFDA/​ReportsManualsForms/​StaffManualGuides/​default.htm.

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

Dated: December 22, 2015.

Sylvia M. Burwell,

Secretary.