Statement of Organization, Functions, and Delegations of Authority, 38158 [2024-09382]

Download as PDF 38158 Federal Register / Vol. 89, No. 89 / Tuesday, May 7, 2024 / Notices The reorganization retitled OCE as the Office of Communication, Information Disclosure, Training, and Education (OCITE); abolished the Digital Communication Media Staff; established the Office of Communication and Content Development (OCCD) and the Office of Training and Education (OTE) within OCITE, established the Division of Digital Communication and Marketing (DDCM) within OCCD, and realigned the existing divisions to the new offices. DCCE. ORGANIZATION. CDRH’s OCITE is headed by the Director, and includes the following: Office of Communication, Information Disclosure, Training, and Education (DCCE) Program Management Operations Staff (DCCE1) Office of Communication and Content Development (DCCEE) Division of Communication (DCCEEA) Division of Information Disclosure (DCCEEB) Division of Digital Communication and Marketing (DCCEEC) Office of Training and Education (DCCEF) Division of Employee Training and Development (DCCEFA) Division of Industry and Consumer Education (DCCEFB) 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. khammond on DSKJM1Z7X2PROD with NOTICES III. Electronic Access This reorganization is reflected in FDA’s Staff Manual Guide (SMG). Persons interested in seeing the complete SMG can find it on FDA’s website at: https://www.fda.gov/ AboutFDA/ReportsManualsForms/Staff ManualGuides/default.htm. (Authority: 44 U.S.C. 3101). Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2024–09381 Filed 5–6–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 15:55 May 06, 2024 Jkt 262001 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. The Food and Drug Administration’s (FDA), Center for Devices and Radiological Health’s (CDRH), Office of Product Evaluation and Quality (OPEQ) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on December 21, 2023, and it became effective on January 22, 2024. FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of Planning, Evaluation and Risk Management, Office of Finance, Budget, Acquisitions and Planning, Food and Drug Administration, 4041 Powder Mill Rd., Beltsville, MD 20705–4304, 301– 796–3843. SUMMARY: 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 amended to reflect the reorganization of the CDRH OCE. The reorganization of OPEQ impacted the OPEQ’s Office of Clinical Evidence and Analysis (OCEA) and the OPEQ’s Office of Health Technology IV (OHT IV). OCEA established the Division of Clinical Evidence and Analysis IV and the Division of Clinical Evidence and Analysis V. OHT IV established the Division of Health Technology IV C. DCCFB. ORGANIZATION. CDRH’s OPEQ OCEA is headed by the Director, and includes the following: Office of Clinical Evidence and Analysis (DCCFB) Division of Clinical Evidence and Analysis I (DCCFBA) Division of Clinical Evidence and Analysis II (DCCFBB) Division of Clinical Evidence and Analysis III (DCCFBC) Division of Clinical Evidence and Analysis IV (DCCFBD) Division of Clinical Evidence and Analysis V (DCCFBE) PO 00000 Frm 00141 Fmt 4703 Sfmt 4703 DCCFF. ORGANIZATION. CDRH’s OPEQ OHT IV is headed by the Director, and includes the following: Office of Health Technology IV (DCCFF) Division of Health Technology IV A (DCCFFA) Division of Health Technology IV B (DCCFFB) Division of Health Technology IV C (DCCFFC) 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 SMG can find it on FDA’s website at: https://www.fda.gov/ AboutFDA/ReportsManualsForms/Staff ManualGuides/default.htm. (Authority: 44 U.S.C. 3101). Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2024–09382 Filed 5–6–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1917] Fresenius Kabi USA, LLC, et. al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of June 6, 2024. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New SUMMARY: E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Page 38158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09382]


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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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA), Center for Devices 
and Radiological Health's (CDRH), Office of Product Evaluation and 
Quality (OPEQ) has modified their organizational structure. The new 
organizational structure was approved by the Secretary of Health and 
Human Services on December 21, 2023, and it became effective on January 
22, 2024.

FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of 
Planning, Evaluation and Risk Management, Office of Finance, Budget, 
Acquisitions and Planning, Food and Drug Administration, 4041 Powder 
Mill Rd., 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 amended to reflect the 
reorganization of the CDRH OCE.
    The reorganization of OPEQ impacted the OPEQ's Office of Clinical 
Evidence and Analysis (OCEA) and the OPEQ's Office of Health Technology 
IV (OHT IV). OCEA established the Division of Clinical Evidence and 
Analysis IV and the Division of Clinical Evidence and Analysis V. OHT 
IV established the Division of Health Technology IV C.
    DCCFB. ORGANIZATION. CDRH's OPEQ OCEA is headed by the Director, 
and includes the following:

Office of Clinical Evidence and Analysis (DCCFB)
Division of Clinical Evidence and Analysis I (DCCFBA)
Division of Clinical Evidence and Analysis II (DCCFBB)
Division of Clinical Evidence and Analysis III (DCCFBC)
Division of Clinical Evidence and Analysis IV (DCCFBD)
Division of Clinical Evidence and Analysis V (DCCFBE)

    DCCFF. ORGANIZATION. CDRH's OPEQ OHT IV is headed by the Director, 
and includes the following:

Office of Health Technology IV (DCCFF)
Division of Health Technology IV A (DCCFFA)
Division of Health Technology IV B (DCCFFB)
Division of Health Technology IV C (DCCFFC)

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 SMG can find it on FDA's 
website 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. 2024-09382 Filed 5-6-24; 8:45 am]
BILLING CODE 4164-01-P
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