[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58806-58807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20997]


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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, Department of Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA), Center for Biologics 
Evaluation and Research (CBER), Office of Tissues and Advanced 
Therapies (OTAT) has modified its organizational structures.

DATES: These new organizational structures were approved by the 
Secretary of Health and Human Services on August 8, 2022, and effective 
on September 16, 2022.

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 the Food and 
Drug Administration's reorganization of CBER, Office of Tissues and 
Advanced Therapies (OTAT).
    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.
    Utilizing key tenets of CBER's modernization efforts, CBER will 
retitle OTAT to the Office of Therapeutic Products (OTP) and elevate 
OTP to a Super Office to manage its program at a macro level and to 
better position the Center to address an everchanging public health 
landscape. With the current and anticipated increase in workloads, the 
proposed structural changes will improve functional alignment, increase 
review capabilities, and enhance expertise on new cell and gene 
therapies. Additional supervisory positions will not only help to 
address this increased workload but will also provide advancement 
opportunities to facilitate recruitment and retention of highly 
qualified staff. The proposal creates flexibility and capacity for 
future growth in Full-Time Employees (FTEs) and workload, avoiding the 
need for continual reorganizations. The reorganization will position 
OTP to focus on commitments, including those negotiated with industry 
in the prescription drug user fee agreement (PDUFA) for FY 2023-2027, 
and other key priorities that protect public health. To advance the 
field and support the next generation of cell and gene therapies, OTP 
will continue to see growth in the Regenerative Medicine Advanced 
Therapy (RMAT) program, established in the 21st Century Cures Act.
    The Food and Drug Administration's Center for Biologics Evaluation 
and Research, Office of Tissues and Advanced Therapies, has been 
restructured as follows:
    DCB. ORGANIZATION. The Center for Biologics Evaluation and Research 
is headed by the Center Director, Center for Biologics Evaluation and 
Research.

Center for Biologics Evaluation and Research (DCB)

Office of Therapeutic Products (DCBG)
Administrative Staff (DCBG1)
Policy and Special Projects Staff (DCBG2)
Office of Gene Therapy CMC (DCBGF)
Division of Gene Therapy I (DCBGFA)
Gene Therapy Branch 1 (DCBGFA1)
Gene Therapy Branch 2 (DCBGFA2)
Gene Therapy Branch 3 (DCBGFA3)
Division of Gene Therapy II (DCBGFB)
Gene Transfer and Immunogenicity Branch (DCBGFB1)
Gene Therapy Branch 4 (DCBGFB2)
Gene Therapy Branch 5 (DCBGFB3)
Office of Cellular Therapy and Human Tissues CMC (DCBGG)
Division of Cell Therapy I (DCBGGA)
Cell Therapy Branch 1 (DCBGGA1)
Cell Therapy Branch 2 (DCBGGA2)
Cellular and Tissue Therapy Branch (DCBGGA3)
Division of Cell Therapy II (DCBGGB)
Tissue Engineering Branch 1 (DCBGGB1)
Tissue Engineering Branch 2 (DCBGGB2)
Tumor Vaccine and Biotechnology Branch (DCBGGB3)
Division of Human Tissues (DCBGGC)
Human Tissues and Reproduction Staff (DCBGGC1)
Office of Plasma Protein Therapeutics CMC (DCBGH)
Division of Hemostasis (DCBGHA)
Hemostasis Branch 1 (DCBGHA1)
Hemostasis Branch 2 (DCBGHA2)
Division of Plasma Derivatives (DCBGHB)
Plasma Derivatives Branch 1 (DCBGHB1)
Plasma Derivatives Branch 2 (DCBGHB2)
Office of Clinical Evaluation (DCBGI)
Division of Clinical Evaluation General Medicine (DCBGIA)
General Medicine Branch 1 (DCBGIA1)
General Medicine Branch 2 (DCBGIA2)
General Medicine Branch 3 (DCBGIA3)
General Medicine Branch 4 (DCBGIA4)
Division of Clinical Evaluation Oncology (DCBGIB)
Oncology Branch 1 (DCBGIB1)
Oncology Branch 2 (DCBGIB2)
Division of Clinical Evaluation Hematology (DCBGIC)
Benign Hematology Branch (DCBGIC1)
Malignant Hematology Branch (DCBGIC2)
Office of Pharmacology/Toxicology (DCBGJ)
Division of Pharmacology/Toxicology I (DCBGJA)
Pharmacology/Toxicology Branch 1 (DCBGJA1)
Pharmacology/Toxicology Branch 3 (DCBGJA2)
Division of Pharmacology/Toxicology II (DCBGJB)
Pharmacology/Toxicology Branch 2 (DCBGJB1)
Pharmacology/Toxicology Branch 4 (DCBGJB2)
Office of Review Management and Regulatory Review (DCBGK)
Division of Review Management and Regulatory Review I (DCBGKA)
Regulatory Review Branch 1 (DCBGKA1)
Review Management Support Branch 1 (DCBGKA2)
Division of Review Management and Regulatory Review II (DCBGKB)

[[Page 58807]]

Regulatory Review Branch 2 (DCBGKB1)
Review Management Support Branch 2 (DCBGKB2)

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: September 23, 2022.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2022-20997 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P


