Notice2021-28385
Statement of Organization, Functions, and Delegations of Authority
Primary source
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Published
January 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration's (FDA), Office of the Commissioner (OC), Office of the Chief Scientist (OCS) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 1 (Monday, January 3, 2022)</title>
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[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Page 94]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28385]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA), Office of the
Commissioner (OC), Office of the Chief Scientist (OCS) 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 the Food and
Drug Administration's reorganization of Office of the Chief Scientist.
The FDA Office of the Commissioner, Office of the Chief Scientist
(OCS), is realigning the FDA Technology Transfer Program (FDATT), from
the Office of Regulatory Science and Innovation (ORSI), OCS, to the OCS
Immediate Office (OCS-IO). This realignment of the FDATT program and
resources intends to further enhance the effectiveness of FDA's
partnership programs by increasing the FDA-wide its efforts to (1)
facilitate the implementation of authorizing legislation for federal
technology transfer, (2) ensure compliance with relevant legal and
regulatory requirements, and (3) establish/maintain related policies
and processes. The realignment will also increase OCS's effectiveness
in driving regulatory science research through external partnerships
and would demonstrate FDA's commitment to strengthening its partnership
and collaboration capabilities, which are key contributors to
sustaining FDA's ability to see and be at the forefront of biomedical
advancements in carrying out its public health mission. Additionally,
OCS is abolishing the Division of Science Innovation & Critical Path
from its Office of Regulatory Science and Innovation (ORSI). ORSI's
programs have evolved away from the need for this division. This
proposed, formal abolishment of the division will serve as a corrective
action to align ORSI's organizational structure with its current
programmatic responsibilities that fulfill its functions. The Food and
Drug Administration's Office of the Chief Scientist has been
restructured as follows:
DCCF. ORGANIZATION. The Office of the Chief Scientist is headed by
the FDA Chief Scientist, and includes the following:
Office of the Chief Scientist (DCP)
Advisory Committee Oversight and Management Staff (DCP1)
FDA Technology Transfer Program Staff (DCP2)
Office of Counter-Terrorism and Emerging Threats (DCPA)
Office of Laboratory Safety (DCPB)
Office of Regulatory Science and Innovation (DCPC)
Office of Scientific Integrity (DCPD)
Office of Scientific Professional Development (DCPE)
National Center for Toxicological Research (DCPF)
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: <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm</a>.
Authority: 44 U.S.C. 3101.
Dated: October 22, 2021.
Andrea Palm,
Deputy Secretary of Health and Human Services.
[FR Doc. 2021-28385 Filed 12-30-21; 8:45 am]
BILLING CODE 4164-01-P
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