81 FR 6524 - Office of Foods and Veterinary Medicine; Center for Food Safety and Applied Nutrition; Statement of Organization, Functions, and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 25 (February 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 25 (February 8, 2016)
| Page Range | 6524-6524 | |
| FR Document | 2016-02444 |
[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)] [Notices] [Page 6524] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02444] [[Page 6524]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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. [FR Doc. 2016-02444 Filed 2-5-16; 8:45 am] BILLING CODE 4160-01-P
![6524 Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices
DEPARTMENT OF HEALTH AND Manufacturing Practices (GMP) DEPARTMENT OF HEALTH AND
HUMAN SERVICES compliance even further through more HUMAN SERVICES
enforcement and more education,
Food and Drug Administration increased attention to products with National Institutes of Health
acute health hazards, finding
Office of Foods and Veterinary efficiencies in New Dietary Ingredient National Institute on Deafness and
Medicine; Center for Food Safety and (NDI) review process, and greater Other Communication; Disorders
Applied Nutrition; Statement of attention to claim substantiation. This Notice of Closed Meeting
Organization, Functions, and reorganization is explained in Staff
Delegations of Authority Manual Guides 1230A.1, 1231.20, and Pursuant to section 10(d) of the
AGENCY: Food and Drug Administration, 1231.21. Federal Advisory Committee Act, as
HHS. FDA, OVFM, CFSAN has been amended (5 U.S.C. App.), notice is
restructured as follows: hereby given of a meeting of the Board
ACTION: Notice. DJJH ORGANIZATION. CFSAN is headed of Scientific Counselors, NIDCD.
by the Center Director and includes the
SUMMARY: Statement of Organizations, The meeting will be closed to the
following organizational units:
Functions, and Delegations of Authority public as indicated below in accordance
Center for Food Safety and Applied Nutrition
The Food and Drug Administration (DJJH) with the provisions set forth in section
(FDA) is announcing that it has Office of the Center Director (DJJHA) 552b(c)(6), Title 5 U.S.C., as amended
reorganized the Office of Foods and Office of Management (DJJHB) for the review, discussion, and
Veterinary Medicine (OFVM), Center for Office of Analytics and Outreach (DJJHC)
evaluation of individual intramural
Food Safety and Applied Nutrition Office of Food Safety (DJJHD)
Office of Cosmetics and Colors (DJJHE) programs and projects conducted by the
(CFSAN) by establishing the new Office
of Dietary Supplement Programs Office of Regulatory Science (DJJHF) National Institute on Deafness and
(ODSP). ODSP will consist of the Office of Food Additive Safety (DJJHG) Other Communication Disorders,
Office of Compliance (DJJHH) including consideration of personnel
Evaluation and Research Staff and the Office of Applied Research and Safety
Regulatory Implementation Staff. This qualifications and performance, and the
Assessment (DJJHI)
reorganization resulted in the retitling of competence of individual investigators,
Office of Regulations, Policy and Social
the OFVM, CFSAN, Office of Nutrition, Sciences (DJJHJ) the disclosure of which would
Labeling and Dietary Supplements Office of Nutrition and Food Labeling constitute a clearly unwarranted
(ONLDS) to the Office of Nutrition and (DJJHK) invasion of personal privacy.
Food Labeling (ONFL), and the Office of Dietary Supplement Programs
Name of Committee: Board of Scientific
abolishment of the Division of Dietary (DJJHL)
Counselors, NIDCD.
Supplement Programs (DDSP) under DJJHK ORGANIZATION. ONFL is headed
Date: March 8, 2016.
ONLDS. This new organizational by the Office Director and includes the
following organizational units: Time: 3:00 p.m. to 4:00 p.m.
structure was approved by the Secretary Agenda: To review and evaluate personal
of Health and Human Services on Office of Nutrition and Food Labeling
(DJJHK) qualifications and performance, and
XXXXX and effective upon signature. Food Labeling and Standards Staff competence of individual investigators.
FOR FURTHER INFORMATION CONTACT: Nutrition Programs Staff Place: National Institutes of Health,
Helio Chaves, Acting Associate Director DJJHL ORGANIZATION. ODSP is headed Building 31, Room 3C05, 31 Center Drive,
for Management, Center for Food Safety by the Office Director and includes the Bethesda, MD 20892 (Telephone Conference
and Applied Nutrition, Office of Foods following organizational units: Call).
and Veterinary Medicine, Food and Office of Dietary Supplement Programs Contact Person: Andrew J. Griffith, Ph.D.,
Drug Administration, 5100 Paint Branch (DJJHL) MD, Director, Division of Intramural
Pkwy., College Park, MD 20740, 240– Evaluation and Research Staff Research, National Institute on Deafness and
402–2471. Regulatory Implementation Staff Other Communication Disorders, 35A
I. Part D, Chapter D–B, (Food and II. Delegations of Authority. Pending Convent Drive, GF 103 Rockville, MD 20892,
Drug Administration), the Statement of further delegation, directives, or orders 301–496–1960, griffita@nidcd.nih.gov.
Organization, Functions, and by the Commissioner of Food and Information is also available on the
Delegations of Authority for the Drugs, all delegations and re-delegations Institute’s/Center’s home page: http://
Department of Health Human Services of authority made to officials and www.nidcd.nih.gov/about/groups/bsc/,
(35 FR 3685, February 25, 1970; 60 FR employees of affected organizational where an agenda and any additional
56605, November 9, 1995; 64 FR 36361, components will continue in them or information for the meeting will be posted
July 6, 1999; 72 FR 50112, August 30, their successors pending further re- when available.
2007; 74 FR 41713, August 18, 2009; delegations, provided they are (Catalogue of Federal Domestic Assistance
and 76 FR 45270, July 28, 2011) is consistent with this reorganization. Program Nos. 93.173, Biological Research
amended to reflect the transfer of DDSP III. Electronic Access. Persons Related to Deafness and Communicative
functions and personnel into ODSP to interested in seeing the completed Staff Disorders, National Institutes of Health, HHS)
better align the mission and day-to-day Manual Guide can find it on FDA’s Dated: February 2, 2016.
activities of DDSP. The reorganization Webs site at: http://www.fda.gov/
Sylvia Neal,
brings more prominence to dietary AboutFDA/ReportsManualsForms/
asabaliauskas on DSK5VPTVN1PROD with NOTICES
supplements, which is a noteworthy StaffManualGuides/default.htm. Program Analyst, Office of Federal Advisory
interest to Congress, increasing the Committee Policy.
Authority: 44 U.S.C. 3101.)
ability to recruit resources and expertise [FR Doc. 2016–02318 Filed 2–5–16; 8:45 am]
to ODSP, and allowing for a more Dated: December 22, 2015. BILLING CODE 4140–01–P
strategic approach in how ODSP Sylvia M. Burwell,
resources are utilized. ODSP will focus Secretary.
on ensuring the integrity of product [FR Doc. 2016–02444 Filed 2–5–16; 8:45 am]
identity, enhancing Good BILLING CODE 4160–01–P
VerDate Sep<11>2014 17:51 Feb 05, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4703 Sfmt 9990 E:\FR\FM\08FEN1.SGM 08FEN1](https://thefederalregister.org/doc/81_FR_6549/page/1.svg)
Document Created: 2016-02-06 00:24:29
Document Modified: 2016-02-06 00:24:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 81 FR 6524 |
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