Document ID: FDA-2022-N-0009-0003
Agency: fda
Document Type: Notice
Title: Statement of Organization, Functions, and Delegations of Authority
Posted Date: 2022-01-03T05:00Z

[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Page 94]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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.
[FR Doc. 2021-28385 Filed 12-30-21; 8:45 am]
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