Document ID: FDA-2023-N-0009-0003
Agency: fda
Document Type: Notice
Title: Statement of Organization, Functions, and Delegations of Authority
Posted Date: 2023-12-05T05:00Z

[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Pages 84336-84337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26512]

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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), Center for Biologics 
Evaluation and Research (CBER), Office of Blood Research and Review 
(OBRR) and the Office of Vaccines Research and Review (OVRR) have 
modified organizational structures.

DATES: These new organizational structures were approved by the 
Secretary of Health and Human Services on June 27, 2023.

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.

SUPPLEMENTARY INFORMATION:

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 CBER, OBRR and OVRR.
    CBER's mission is to protect and enhance public health through the 
regulation of biological and related products including blood, 
vaccines, allergenics, tissues, and cellular and gene therapies. With 
substantial growth in innovative, novel products, as well as a need to 
address an ever-changing landscape of potential public health threats, 
CBER is currently facing scientific, medical, and regulatory challenges 
that require changes to its structure.
    In OBRR, the establishment of a Laboratory of Pathogen Reduction 
will address Center-level initiatives focusing on the optimization of 
new pathogen inactivation technologies. These technologies can 
dramatically help the American public and potentially reduce or 
eliminate donor deferral and/or testing requirements. Additionally, the 
proposed structural changes, keeping OBRR's functioning state of two 
divisions instead of three, will maintain operational consistency and 
enable the divisions to build on processes and efficiencies gained in 
the last 2 years.
    In OVRR, the Division of Vaccines and Related Product Applications 
will split into the Division of Review Management and Regulatory Review 
and the Division of Clinical and Toxicology Review to allow for 
improved operational efficiency, appropriate supervisory ratios, and a 
better balance of workload within an area of increased demand.
    Under Part D, FDA's CBER, Office of Blood Research and Review, has 
been restructured as follows:
    DCB. ORGANIZATION. CBER is headed by the Center Director, Center 
for Biologics Evaluation and Research.

Center for Biologics Evaluation and Research (DCB)

Office of Blood Research and Review (DCBE)
    Administrative Staff (DCBE1)
    Regulatory Project Management Staff (DCBE2)
Laboratory of Pathogen Reduction (DCBE3)
Division of Emerging and Transfusion Transmitted Diseases (DCBEA)
    Laboratory of Molecular Virology (DCBEA1)
    Laboratory of Emerging Pathogens (DCBEA2)
    Product Review Branch (DCBEA4)
    Laboratory of Emerging Pathogens (DCBEA2)
    Product Review Branch (DCBEA4)
Division of Blood Components and Devices (DCBEB)
    Devices Review Branch (DCBEB2)
    Blood and Plasma Branch (DCBEB6)
    Laboratory of Cellular Hematology (DCBEB7)
    Laboratory of Biochemistry and Vascular Biology (DCBEB8)

    Under Part D, FDA's CBER, Office of Vaccines Research and Review, 
has been restructured as follows:
    DCB. ORGANIZATION. CBER is headed by the Center Director, Center 
for Biologics Evaluation and Research.

Center for Biologics Evaluation and Research (DCB)

Office of Vaccines Research and Review (DCBF)
    Program Operations Staff (DCBF1)
Division of Bacterial Parasitic and Allergenic Products (DCBFA)
    Laboratory of ImmunoBiochemistry (DCBFA1)
    Laboratory of Respiratory and Special Pathogens (DCBFA2)
    Laboratory of Bacterial Polysaccharides (DCBFA3)
    Laboratory of Mucosal Pathogens and Cellular Immunology (DCBFA4)
Division of Viral Products (DCBFB)
    Laboratory of Pediatric and Respiratory Viral Diseases (DCBFB1)
    Laboratory of Hepatitis Viruses (DCBFB2)
    Laboratory of Retroviruses (DCBFB3)
    Laboratory of DNA Viruses (DCBFB4)
    Laboratory of Vector Borne Diseases (DCBFB5)
    Laboratory of Method Development (DCBFB6)
    Laboratory of Immunoregulation (DCBFB7)
Division of Review Management and Regulatory Review (DCBFD)
    Regulatory Review Branch 1 (DCBFD1)
    Regulatory Review Branch 2

[[Page 84337]]

(DCBFD2) Regulatory Review Branch 3 (DCBFD3)
    Review Management Support Branch (DCBFD4)
Division of Clinical and Toxicology Review (DCBFE)
    Clinical Review Branch 1 (DCBFE1)
    Clinical Review Branch 2 (DCBFE2)
    Clinical Review Branch 3 (DCBFE3)
    Toxicology Staff (DCBFE4)

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

    After completion of the necessary requirements for implementation, 
this reorganization will be reflected in FDA's Staff Manual Guide (SMG) 
at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
    Authority: 44 U.S.C. 3101.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-26512 Filed 12-4-23; 8:45 am]
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