Notice2022-20997
Statement of Organization, Functions, and Delegations of Authority
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 28, 2022
Effective
September 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 187 (Wednesday, September 28, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58806-58807]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20997]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: <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: 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
</pre></body>
</html>Indexed from Federal Register on September 28, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.