Statement of Organization, Functions, and Delegations of Authority, 47567-47576 [2024-11893]
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Federal Register / Vol. 89, No. 107 / Monday, June 3, 2024 / Notices
47567
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued
Application No.
Drug
Applicant
NDA 019826 ......
B. Braun Medical Inc, 901 Marcon Blvd., Allentown, PA
18109.
NDA 020928 ......
Theophylline and Dextrose 5% Injections in Plastic Container, 40 mg/100 milliliters (mL), 80 mg/100 mL, 160 mg/
100 mL, 200 mg/100 mL, 320 mg/100 mL, and 400 mg/
100 mL.
Norvir (ritonavir) Oral Solution, 80 mg/mL ...............................
Emadine (emedastine difumarate) Ophthalmic Solution,
0.05%.
Aggrenox (aspirin and dipyridamole) Extended-Release Capsules, 25 mg/200 mg.
Glucagon Injection, 1 mg/vial ...................................................
NDA 020972 ......
Sustiva (efavirenz) Capsules, 50 mg, 100 mg, and 200 mg ...
NDA 021400 ......
NDA 021449 ......
Levitra (vardenafil HCI) Tablets, 2.5 mg, 5 mg, 10 mg, and
20 mg.
Hepsera (adefovir dipivoxil) Tablets, 10 mg ............................
NDA 021623 ......
Synera (lidocaine and tetracaine) Patch, 70 mg/70 mg ..........
NDA 022331 ......
Kapvay (clonidine HCl) Extended-Release Tablets, 0.1 mg
and 0.2 mg.
Jenloga (clonidine HCl) Extended-Release Tablets, 0.1 mg
and 0.2 mg.
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Tablets, 600 mg/300 mg/300 mg.
NDA 020659 ......
NDA 020706 ......
NDA 020884 ......
NDA 022343 ......
NDA 022344 ......
NDA 205004 ......
Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 300
mg/300 mg.
Staxyn (vardenafil HCl) Orally Disintegrating Tablets, 10 mg
Durlaza (aspirin) Extended-Release Capsules, 162.5 mg ......
Radiogenix System (technetium Tc-99m generator) For the
Production of Sodium Pertechnetate Tc 99m Injection, Intravenous, Intravesicular, and Ophthalmic Solution, 30–
1153 millicurie/Generator.
Bortezomib Powder for Injection, 3.5 mg/vial ..........................
NDA 205787 ......
Evzio (naloxone HCl) Solution for Injection, 0.4 mg/0.4 mL ...
NDA 209862 ......
Evzio (naloxone HCl) Auto-Injector for Injection, 2 mg/0.4 mL
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NDA 200179 ......
NDA 200671 ......
NDA 202158 ......
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of July 3, 2024.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms included in the
application but inadvertently missing
from table 1. Introduction or delivery for
introduction into interstate commerce of
products listed in table 1 without an
approved new drug application violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in table 1 that are in inventory
on July 3, 2024 may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
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AbbVie Inc. 1 N. Waugekan Rd., North Chicago, IL 60064.
Novartis Pharmaceuticals Co., 1 Health Plaza, East Hanover,
NJ 07936–1080
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury
Rd, Ridgefield, CT 06877.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis,
IN 46285.
Bristol-Myers Squibb Company, P.O. Box 4000, Princeton,
NJ 08543–4000.
Bayer HealthCare Pharmaceuticals Inc.
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA
94404.
Galen Specialty Pharma US, LLC, 25 Fretz Rd., Souderton,
PA 18694.
Concordia Pharmaceuticals, Inc C/O Cardinal Health Reg
Sciences, 7400 West 110th St., Suite 150, Overland Park,
KS 66210.
Aurobindo Pharma Limited C/O Aurobindo Pharma USA,
Inc., 279 Princeton-Highstown Rd., East Windsor, NJ
08520.
Do.
Bayer HealthCare Pharmaceuticals, Inc.
HESP LLC, 312 Farmington Ave., Farmington, CT 06032.
NorthStar Medical Radioisotopes, LLC, 1800 Gateway Blvd.,
Beloit, WI 53511.
Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL
60047.
Kaleo, Inc., 111 Virginia St., Suite 300, Richmond, VA
23219.
Do.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12065 Filed 5–31–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
Food and Drug Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA), Office of the
Commissioner, Headquarters
organizations, and Centers have
modified their organizational structure
DATES: This organization was approved
by the Secretary of Health and Human
SUMMARY:
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Services on March 5, 2024, and became
effective on May 13, 2024.
FOR FURTHER INFORMATION CONTACT:
Yashika Rahaman, Director, Office of
Planning, Evaluation, and Risk
Management, Office of the Finance,
Budget, Acquisitions and Planning,
Food and Drug Administration, 10903
New Hampshire Avenue, WO32, Room
4216, Silver Spring, MD 20993, 301–
796–4710.
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 approved Food
and Drug Administration’s Human
Foods reorganization.
SUPPLEMENTARY INFORMATION:
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The Food and Drug Administration
(FDA) is focused on transforming its
organization structure to be more
efficient, nimble, and ready for the
future with the ever-changing and
complex industries we regulate,
including the emergence of new food
and medical product technologies, the
impacts of globalization, climate change
and other factors that require FDA to
quickly adapt to a consistently evolving
world.
FDA carefully reviewed the findings
and recommendations of the ReaganUdall Foundation evaluation, an
internal review of FDA’s infant formula
response and feedback from external
and internal stakeholders during events
such as listening sessions with FDA
employees. The approved changes in
the Human Foods Program (HFP) would
allow us to fully realize the preventive
vision laid out in the FDA Food Safety
Modernization Act, elevate the
importance of nutrition, strengthen
local, state, and international
partnerships, position the FDA to
regulate innovative food and
agricultural products more effectively,
and uphold safety of the nation’s food
supply. The organizational changes
impact other products that FDA
regulates, such as medical products and
cosmetics, by promoting more
streamlined, efficient decision-making
and strengthening the enterprise-wide
structure to enhance collaboration
across FDA.
The intent is to have a modernized
FDA that optimizes resources to help
the agency meet its public health
mission; provide employees with clearer
priorities and more career opportunities;
and comply with recent legislation such
as the Food and Drug Omnibus Reform
Act of 2022 (FDORA) mandating the
establishment of the Office of Critical
Foods, and the Modernization of
Cosmetics Regulation Act of 2022
(MoCRA) to ensure the safety of
cosmetics products.
The reorganization establishes the
HFP by realigning the functions of the
Center for Food Safety and Applied
Nutrition (CFSAN), Office of Food
Policy and Response, as well as key
functions from the Office of Regulatory
Affairs (ORA) including human foods
compliance, Human and Animal Food
Laboratories, and State Partnerships to
this new organization. The
reorganization will also:
Realign ORA’s compliance functions
to Center for Biologics Evaluation and
Research’s Office of Compliance and
Biologics Quality, Center for Devices
and Radiological Health’s Office of
Product Evaluation and Quality, Center
for Drug Evaluation and Research’s
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Office of Compliance and its
substructure organizations, and the
Center for Veterinary Medicine’s Office
of Surveillance and Compliance.
Realign ORA’s laboratory safety
functions and resources as well as the
Medical Product and Specialty
Laboratories safety functions and
resources to the Office of the Chief
Scientist.
Retitle ORA to the Office of
Inspections and Investigations (OII) and
establish new inspection and
investigation offices to focus on
inspections, investigations, and imports
as its core mission.
Realign emergency response functions
and resources from the Office of
Operations’ Office of Security and
Emergency Management to OII.
Realign select functions to strengthen
the Office of the Commissioner (OC) and
headquarter organizations, including:
Establish, within OC immediate
organization, the Office of Enterprise
Transformation to focus on key
information technology transformation
projects across FDA.
Realign the Office of Planning,
Evaluation and Risk Management,
within OC immediate organization, to
focus on strategic initiatives for FDA.
Retitle the Office of Clinical Policy
and Programs and realign functions to
form the Office of the Chief Medical
Officer.
Retitle the Office of External Affairs’
Stakeholder Engagement Staff to Public
Engagement Staff.
Realign select functions to strengthen
the Office of Operations (OO) and
substructure organizations, including:
Realign the Office of Executive
Secretariat’s Freedom of Information
Staff functions and resources from the
OC’s Immediate Office to OO’s Office of
Enterprise Management Services
(OEMS) to consolidate and streamline
information disclosure operations.
Retitle OO’s OEMS to the Office of
Management and Enterprise Services
(OMES). Restructure the organization by
establishing two office level
organizations: the Office of Disclosure,
Information Governance, and
Accessibility (ODIGA) and the Office of
Management (OM) and substructure
organizational components within
OMES.
Retitle OO’s Office of Security and
Emergency Management (OSEM) to the
Office of Security and Passport
Operations (OSPO). Abolish the
substructure organizations, and
establish the Division of Personnel
Security and Credentialing, the Division
of Physical Security and Integration,
and the Division of Resource Integration
and Passport Operations.
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Retitle OO’s Office of Finance,
Budget, Acquisitions and Planning
(OFBAP) to the Office of Finance,
Budget, and Acquisitions (OFBA).
Realign travel functions and resources
from ORA to the Office of Financial
Management within OFBA.
Abolish OO’s Office of Facilities
Engineering and Mission Support
Services’ (OFEMS) Employee Safety and
Occupational Health Staff (ESOHS) and
realign emergency safety and
occupational health functions from
OFEMS to the Office of the Chief
Scientist (OCS).
Realign select functions to strengthen
the OCS and substructure organizations,
as follows:
Establish an Administrative Staff
organizational component and realign
functions and resources from within the
immediate organization into this new
component.
Realign the Informatics and Business
Operations Staff from the ORA Office of
Regulatory Science to the OCS
immediate organization.
Merge the Office of Counter-Terrorism
and Emerging Threats, and the Office of
Regulatory Science and Innovation, to
form the Office of Regulatory and
Emerging Science. Establish the
Communications and Outreach Staff,
the Preparedness Research Staff and the
Regulatory Science Staff to this new
organization.
Merge the Office of Laboratory Safety
and OO’s ESOH within OFEMS to the
organization titled as the Office of
Occupational Safety and Health
(OOSH). Within the OOSH, merge the
functions of the former OO ESOH with
those of the OCS Office of Laboratory
Safety, and establish the Occupational
Safety Staff and the Occupational
Health Services Staff to this new
organizational component.
Realign the Office of Cosmetics and
Colors organization, including its
Divisions and Branches, functions and
resources, from CFSAN to OCS.
Establish the Office of Analytical and
Regulatory Laboratories and realign
resources from the ORA Office of
Medical Products Laboratory Operations
and substructure organizations, and
realign functions from within the
CFSAN Office of Regulatory Science to
this new organization which will be a
direct report to OCS.
Establish the Office of Specialty
Laboratories and Enforcement Support
and realign functions from the ORA’s
Office of Medical Products Laboratory
Operations within the Office of
Regulatory Science to this new
organization which will be a direct
report to OCS.
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Establish the Office of Science and
Laboratory Advancement and realign
functions from ORA’s Office of Safety
within the Office of Regulatory Science
to this new organization which will be
a direct report to OCS.
DCA. ORGANIZATION. To reflect
these changes, Part D, Section D–B, is
replaced with the following:
The Office of the Commissioner is
headed by the Commissioner of Food
and Drugs, and includes the following
organizational units:
Office of the Commissioner (DCA)
Office of the Chief Counsel (DCAA)
Office of the Executive Secretariat
(DCAB)
Office of the Counselor to the
Commissioner (DCAC)
Office of Digital Transformation (DCAD)
Strategy and Operations Staff (DCAD1)
Office of Information Management and
Technology (DCADA)
Office of Technology and Delivery
(DCADAA)
Delivery Management Support Staff
(DCADAA1)
Division of Infrastructure Operations
(DCADAAA)
Infrastructure Management Services
Staff (DCADAAA1)
Implementation Branch (DCADAAA2)
Infrastructure Engineering Branch
(DCADAAA3)
Systems Monitoring and Response
Branch (DCADAAA4)
Systems Operations Branch
(DCADAAA5)
Network and Communications
Operations Branch (DCADAAA6)
Division of Application Services
(DCADAAB)
Application Management Services Staff
(DCADAAB1)
Data Management and Operations
Branch (DCADAAB2)
Medical Products Branch (DCADAAB3)
OC, CVM, CTP Branch (DCADAAB4)
ORA, CFSAN Branch (DCADAAB5)
Enterprise Application Branch
(DCADAAB6)
Office of Business and Customer
Assurance (DCADAB)
Division of Business Partnership and
Support (DCADABA)
Internet and Intranet Branch
(DCADABA1)
Call Center Branch (DCADABA2)
Regional Support Branch (DCADABA3)
Property Receiving and Distribution
Branch (DCADABA4)
Employee Resource and Information
Center (DCADABA5)
Division of Management Services
(DCADABB)
Office of Enterprise Portfolio
Management (DCADAC)
Office of Information Security (DCADB)
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Office of Data Analytics and Research
(DCADC)
Data Staff (DCADC1)
Health Informatics Staff (DCADC2)
Knowledge Management Staff
(DCADC3)
Office of Enterprise Transformation
(DCAE)
Office of Planning, Evaluation, and Risk
Management (DCAG)
Administrative Staff (DCAG1)
Strategic Planning and Change
Management Staff (DCAG2)
Evaluation and Analytics Staff (DCAG3)
Enterprise Risk Management Staff
(DCAG4)
Performance Management Staff
(DCAG5)
DCBC. ORGANIZATION. The Office
of Compliance and Biologics Quality
within the Center for Biologics
Evaluation and Research is headed by
the Director for Compliance and
Biologics Quality and includes the
following organizational units:
Office of Compliance and Biologics
Quality (DCBC)
Division of Case Management (DCBCA)
Blood and Tissue Compliance Branch
(DCBCA1)
Advertising and Promotional Labeling
Branch (DCBCA2)
Biological Drug and Device Compliance
Branch 1 (DCBCA3)
Biological Drug and Device Compliance
Branch 2 (DCBCA4)
Division of Inspections and Surveillance
(DCBCB)
Program Surveillance Branch (DCBCB1)
Bioresearch Monitoring Branch
(DCBCB2)
Field Surveillance Branch (DCBCB3)
Division of Manufacturing and Product
Quality (DCBCC)
Product Release Branch (DCBCC1)
Manufacturing Review Branch 1
(DCBCC2)
Manufacturing Review Branch 2
(DCBCC3)
Manufacturing Review Branch 3
(DCBCC4)
Applications Review Branch (DCBCC5)
Division of Biological Standards and
Quality Control (DCBCD)
Quality Assurance Branch (DCBCD2)
Laboratory of Microbiology, In-Vivo
Testing and Standards Branch
(DCBCD3)
Laboratory of Analytical Chemistry
(DCBCD4)
Laboratory of Biochemistry, Virology,
and Immunochemistry Branch
(DCBCD5)
Laboratory of Blood Related Products
Branch (DCBCD6)
DCDF. ORGANIZATION. The Office
of Compliance within the Center for
Drug Evaluation and Research is headed
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47569
by the Director for Compliance and
includes the following organization
units:
Office of Compliance (DCDF)
Program Management and Analysis Staff
(DCDF1)
Office of Manufacturing Quality
(DCDFA)
Manufacturing Guidance and Policy
Staff (DCDFA1)
Regulatory Compliance and Analysis
Staff (DCDFA2)
Division of Drug Quality I (DCDFAA)
Division of Drug Quality II (DCDFAB)
Division of Drug Quality III (DCDFD)
Office of Unapproved Drugs and
Labeling Compliance (DCDFB)
Division of Unapproved New Drugs and
Labeling (DCDFBB)
Fraud Drugs Branch (DCDFBB2)
Prescription Drugs Branch (DCDFBB3)
Division of Labeling, Regulation,
Regulation and Unapproved Drugs
(DCDFBC)
Over-The-Counter Drug Branch
(DCDFBC1)
Drug Registration and Listing Branch
(DCDFBC2)
Office of Scientific Investigations
(DCDFC)
Policy Staff (DCDFC1)
Division of Good Clinical Practice
Compliance (DCDFCA)
Good Clinical Practice Enforcement
Branch (DCDFCA1)
Good Clinical Practice Assessment
Branch (DCDFCA2)
Division of Safety Compliance
(DCDFCB)
Division of Enforcement and Postmarket Safety (DCDFCC)
Compliance Enforcement Branch
(DCDFCC1)
Post-marketing Safety Branch
(DCDFCC2)
Division of Clinical Compliance
Evaluation (DCDFCD)
Good Clinical Practice Compliance
Oversight Branch DCDFCD1)
Good Clinical Practice Assessment
Branch (DCDFCD2)
Office of Drug Security Integrity and
Response (DCDFD)
Division of Global Drug Distribution and
Policy (DCDFDA)
Imports Compliance Branch (DCDFDA3)
Exports Compliance Branch (DCDFDA4)
Division of Supply Chain Integrity
(DCDFDB)
Incidents, Recalls, and Shortage Branch
(DCDFDB3)
Supply Chain Security Branch
(DCDFDB4)
Office of Program and Regulatory
Operations (DCDFE)
Program and Regulatory Operations
Staff 1 (DCDFE1)
Program and Regulatory Operations
Staff 2 (DCDFE2)
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Project Management and Coordination
Staff 3 (DCDFE4)
Office of Compounding Quality and
Compliance (DCDFF)
Division of Compounding I (DCDFFA)
Compounding Branch 1 (DCDFFA1)
Compounding Branch 2 (DCDFFA2)
Compounding Branch 3 (DCDFFA3)
Division of Compounding II (DCDFFB)
Compounding Branch 4 (DCDFFB2)
Compounding Branch 5 (DCDFFB3)
Compounding Branch 6 (DCDFFB4)
Division of Compounding Policy and
Outreach (DCDFFC)
Compounding Branch 7 (DCDFFC3)
Compounding Branch 8 (DCDFFC4)
DCGD. ORGANIZATION. The Office
of Surveillance and Compliance within
the Center for Veterinary Medicine is
headed by the Director of Surveillance
and Compliance and includes the
following organization units:
Office of Surveillance and Compliance
(DCGD)
Regulatory Counsel Staff (DCGD1)
Business Management and Operations
Staff (DCGD2)
Division of Pharmacovigilance and
Surveillance (DCGDA)
Marketed Product Information Branch
(DCGDA1)
Food Animal, BioPharm, Small Animal
Antiparasitics and Endectocides
Branch (DCGDA2)
Small Animal Antibiotics/Anesthectics/
NSAIDS/Oncology/Others Branch
(DCGDA3)
Division of Animal Food Ingredients
(DCGDB)
Program-Business Branch (DCGDB1)
Biotechnology Branch (DCGDB2)
Chemistry Manufacturing and Controls
(CMC) Tech Additives Branch
(DCGDB3)
Nutrients Claims Branch (DCGDB4)
Division of Drug Compliance (DCGDC)
Drug and Devices—Veterinary Medical
Support Branch (DCGDC1)
Drug and Devices-Compliance Support
Branch (DCGDC2)
Bioresearch Monitoring (BIMO) and
Current Good Manufacturing Practice
(CGMP) Branch (DCGDC3)
Division of Food Compliance (DCGDE)
Complaints, Emergencies, and Recall
Team (CERT) Branch (DCGDE1)
Field Operations and Investigations
Branch (DCGDE2)
Regulatory Policy and Program Branch
(DCGDE3)
Science Policy Branch (DCGDE4)
Compliance Action Branch (DCGDE5)
DCJ. ORGANIZATION. The Office of
the Chief Medical Officer is headed by
the Chief Medical Officer, and includes
the following organization units:
Office of the Chief Medical Officer (DCJ)
Office of Clinical Policy (DCJA)
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Office of Combination Products (DCJB)
Office of Orphan Products Development
(DCJC)
Office of Pediatric Therapeutics (DCJD)
Office of Public Health Preparedness
and Response (DCJE)
DCK. ORGANIZATION. The Office of
External Affairs is headed by the
Associate Commissioner for External
Affairs, and includes the following
organization units:
Office of External Affairs (DCK)
Operations Staff (DCK1)
Public Engagement Staff (DCK3)
Web and Digital Services Staff (DCK4)
Office of Editorial and Creative Services
(DCKA)
Office of Media Affairs (DCKB)
DCN. ORGANIZATION. The Office of
Operations is headed by the Deputy
Commissioner for Operations and Chief
Operations Officer and includes the
following organization units:
Office of Operations (DCN)
Office of Management and Enterprise
Services (DCNA)
Office of Disclosure, Information
Governance, and Accessibility
(DCNAF)
Division of Information Governance
(DCNAFA)
eDiscovery Branch (DCNAFA1)
Records Management Branch
(DCNAFA2)
Paperwork Reduction Act Branch
(DCNAFA3)
Privacy Branch (DCNAFA4)
Dockets Management Branch
(DCNAFA5)
Division of Information Disclosure
(DCNAFB)
Freedom of Information Branch
(DCNAFB1)
Disclosure Branch (DCNAFB2)
Division of Headquarters Freedom of
Information (DCNAFC)
Division of Conflict Prevention, and
Accessibility (DCNAFD)
Conflict Prevention and Resolution
Branch (DCNAFD1)
Reasonable Accommodations Branch
(DCNAFD2)
Office of Management (DCNAG)
Division of Resources Management
(DCNAGA)
Office of the Commissioner Resource
Management Branch (DCNAGA1)
Global Policy and Strategy Resource
Management Branch (DCNAGA2)
Division of Human Capital (DCNAGB)
Human Capital Management Branch
(DCNAGB1)
Human Capital Programs Branch
(DCNAGB2)
Division of Acquisitions Management
(DCNAGC)
Acquisitions Management Branch
(DCNAGC1)
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Acquisitions Support Branch
(DCNAGC2)
Division of Management Services
(DCNAGD)
Communications Branch (DCNAGD1)
Governance Branch (DCNAGD2)
Office of Ethics and Integrity (DCNB)
Office of Equal Employment
Opportunity (DCNC)
Compliance Staff (DCNC1)
Office of Finance, Budget, and
Acquisitions (DCNE)
Business Management Services Staff
(DCNE1)
Office of Budget (DCNEA)
Division of Budget Formulation
(DCNEAA)
Division of Budget Execution and
Control (DCNEAB)
Division of Reorganizations and
Delegations of Authority (DCNEAC)
Office of Acquisitions and Grants
Services (DCNEB)
Training and Development Staff
(DCNEB1)
Division of Acquisition Operations
(DCNEBA)
Service Contracts Branch (DCNEBA1)
Contracts Operations Branch
(DCNEBA2)
Scientific Support Branch (DCNEBA3)
Division of Acquisition Programs
(DCNEBB)
Field Operations Branch (DCNEBB2)
Facilities Support Branch (DCNEBB3)
ORA Inspection Branch (DCNEBB4)
CTP Inspection Branch (DCNEBB5)
Division of Grants, Agreements and
Acquisitions Support (DCNEBC)
Grants and Assistance Agreements
Branch (DCNEBC1)
Contracts Administration Branch
(DCNEBC4)
Division of Information Technology
Acquisitions (DCNEBD)
Information Technology Acquisitions
Branch (DCNEBD1)
Systems Technology Acquisitions
Branch (DCNEBD2)
IT Strategic Support Branch (DCNEBD3)
Division of Policy, Systems and Program
Support (DCNEBE)
Acquisitions Policy and Oversight
Branch (DCNEBE2)
Innovation Systems and Data Quality
Branch (DCNEBE3)
Office of Financial Management
(DCNEC)
Financial Systems Support Staff
(DCNEC1)
User Fee Support Staff (DCNEC2)
Operations Support Staff (DCNEC3)
Controls, Compliance and Oversight
Staff (DCNEC4)
Division of Accounting (DCNECA)
Division of Payment Services (DCNECC)
Division of Travel Services (DCNECD)
Office of Facilities, Engineering and
Mission Support Services (DCNG)
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Jefferson Laboratories Complex Staff
(DCNG1)
Facilities Program Staff (DCNG2)
Division of Operations Management and
Community Relations (DCNGA)
Logistics and Transportation
Management Branch (DCNGA1)
Facilities Maintenance and Operations
Branch (DCNGA2)
Auxiliary Program Management Staff
(DCNGA3)
Division of Planning, Engineering and
Space Management (DCNGB)
Portfolio and Space Management
Branch (DCNGB1)
Engineering Management Branch
(DCNGB2)
Office of Security and Passport
Operations (DCNH)
Special Operations Staff (DCNH1)
Division of Resource Integration and
Passport Operations (DCNHC)
Resource Integration Branch (DCNHC1)
Passport Operations Branch (DCNHC2)
Division of Personnel Security and
Credentialing (DCNHD)
Personnel Vetting Branch (DCNHD1)
Identity and Credentialing Services
Branch (DCNHD2)
Division of Physical Security and
Integration (DCNHE)
Physical Security Branch (DCNHE1)
Security Integration Branch (DCNHE2)
Office of Human Capital Management
(DCNI)
Office of Talent Solutions (DCNJ)
Office of FDA Commissioned Corps
(DCNK)
DCP. ORGANIZATION. The Office of
the Chief Scientist is headed by the
Chief Scientist and includes the
following organization units:
Office of the Chief Scientist (DCP)
Advisory Committee Oversight and
Management Staff (DCP1)
FDA Technology Transfer Program Staff
(DCP2)
Administrative Management Staff
(DCP3)
Informatics and Business Operations
Staff (DCP4)
Office of Scientific Integrity (DCPD)
Office of Scientific Professional
Development (DCPE)
National Center for Toxicological
Research (DCPF)
Office of Occupational Safety and
Health (DCPG)
Occupational Safety Staff (DCPG1)
Occupational Health Services Staff
(DCPG2)
Office of Regulatory and Emerging
Science (DCPH)
Regulatory Science Staff (DCPH1)
Preparedness Research Staff (DCPH2)
Communications and Outreach Staff
(DCPH3)
Office of Cosmetics and Colors (DCPI)
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Division of Color Certification and
Technology (DCPIA)
Color Certification Branch (DCPIA1)
Color Technology Branch (DCPIA2)
Division of Cosmetics (DCPIB)
Cosmetics Regulatory Activities Branch
(DCPIB1)
Cosmetics Regulatory Science Branch
(DCPIB2)
Office of Analytical and Regulatory
Laboratories (DCPJ)
Analytical and Regulatory Laboratories
Staff (DCPJ1)
Detroit Medical Products Laboratory
(DCPJA)
Irvine Medical Products Laboratory
(DCPJB)
New York Medical Products Laboratory
(DCPJC)
San Juan Medical Products Laboratory
(DCPJD)
Tobacco Products Laboratory (DCPJE)
Office of Specialty Laboratories and
Enforcement Support (DCPK)
National Forensic Chemistry Center
(DCPKA)
Inorganic Branch (DCPKA1)
Organic Branch (DCPKA2)
Satellite Laboratory Branch (DCPKA3)
Winchester Engineering and Analytical
Center (DCPKB)
Analytical Branch (DCPKB1)
Engineering Branch (DCPKB2)
Office of Science and Laboratory
Advancement (DCPL)
Regulatory Operations Safety Staff
(DCPL1)
DCR. ORGANIZATION. The Human
Foods Program is headed by the Deputy
Commissioner for Human Foods, and
includes the following organizational
units:
Human Foods Program (DCR)
Office of the Deputy Commissioner for
Human Foods (DCRA)
Management Operations Staff (DCRA1)
Office of Executive Programs (DCRB)
Project and Portfolio Management Staff
1 (DCRB1)
Project and Portfolio Management Staff
2 (DCRB2)
Legislative and Program Issue
Coordination and Executive
Secretariat Staff (DCRB3)
Office of Strategic Programing (DCRC)
Office of Policy and International
Engagement (DCRD)
Office of Policy, Regulations, and
Information (DCRDA)
Regulation and Policy Development
Staff (DCRDA1)
Government Information Policy Staff
(DCRDA2)
Office of Policy Initiatives and Projects
(DCRDB)
Office of International Engagement
(DCRDC)
Public Health and Trade Staff (DCRDC1)
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Regulatory Cooperation and
Partnerships Staff (DCRDC2)
Office of Resource Management (DCRE)
Division of Budget and Planning
(DCREA)
Budget Formulation Branch (DCREA1)
Budget Execution Branch (DCREA2)
Acquisition Liaison Branch (DCREA3)
Financial Operations Branch (DCREA4)
Division of Workforce Management
(DCREB)
Recruitment Liaison Branch (DCREB1)
Workforce Policy and Programs Branch
(DCREB2)
Staff College (DCREB3)
Division of Information Technology
Management (DCREC)
Regulatory and Data Management
Branch (DCREC1)
Scientific Computing and IT Support
Branch (DCREC2)
Division of Safety and Facilities
Management (DCRED)
Division of Travel Management and
Operations Support (DCREE)
Division of Management Support and
Analysis (DCREF)
Office of Communications, Education,
and Engagement (DCRF)
Internal Communications Staff (DCRF1)
Division of External Communications
and Consumer Education (DCRFA)
Strategic Communications Branch
(DCRFA1)
Consumer Education Branch (DCRFA2)
Division of Public Engagement and
Information (DCRFB)
Public Engagement Branch (DCRFB1)
Public Information Branch (DCRFB2)
Division of Web, Visual, and Virtual
Communications (DCRFC)
Web Branch (DCRFC1)
Graphics and Virtual Collaboration
Branch (DCRFC2)
Office of Surveillance Strategy and Risk
Prioritization (DCRG)
Advisory and Operations Staff (DCRG1)
Division of Surveillance and Data
Integration (DCRGA)
Surveillance Design Branch (DCRGA1)
Signal Detection and Bioinformatics
Branch (DCRGA2)
Surveillance Systems Operations
Branch (DCRGA3)
Data Integration Branch (DCRGA4)
Division of Risk Assessment and
Prioritization (DCRGB)
Hazard Characterization and
Assessment Branch (DCRGB1)
Exposure Assessment Branch (DCRGB2)
Risk Assessment and Ranking Branch
(DCRGB3)
Division of Evaluation and Population
Health Science (DCRGC)
Behavioral and Social Sciences Branch
(DCRGC1)
Epidemiology and Medical Sciences
Branch (DCRGC2)
Signal Coordination and Triage Branch
(DCRGC3)
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Office of Coordinated Outbreak
Response, Evaluation and Emergency
Preparedness (DCRH)
Division of Outbreak Data Management
and Signals (DCRHA)
Division of Response (DCRHB)
Division of Preparedness and
Emergency Programs (DCRHC)
Office of Compliance and Enforcement
(DCRI)
Administrative Staff (DCRI1)
Compliance Initiatives Staff (DCRI2)
Office of Compliance Operations and
Implementation (DCRIA)
Division of Compliance Operations
(DCRIAA)
Compliance Operations Planning
Branch (DCRIAA1)
Compliance Operations Analysis Branch
(DCRIAA2)
Division of Compliance Implementation
(DCRIAB)
Compliance Policy and Procedures
Branch (DCRIAB1)
Compliance Programs and Assignments
Branch (DCRIAB2)
Office of Enforcement (DCRIB)
Division of Critical Foods and Dietary
Supplement Enforcement (DCRIBA)
Dietary Supplements Enforcement
Branch (DCRIBA1)
Critical Foods and Labeling
Enforcement Branch (DCRIBA2)
Division of Conventional Foods
Enforcement (DCRIBB)
Conventional Foods Enforcement
Branch 1(DCRIBB1)
Conventional Foods Enforcement
Branch 2 (DCRIBB2)
Conventional Foods Enforcement
Branch 3 (DCRIBB3)
Division of Produce and Imports
Enforcement (DCRIBC)
Imports Enforcement Branch (DCRIBC1)
Produce Enforcement Branch (DCRIBC2)
Office of Compliance Intervention and
Consultation (DCRIC)
Division of Recalls and Emerging Issues
(DCRICA)
Recalls Branch (DCRICA1)
Emerging Issues Branch (DCRICA2)
Division of Compliance Consultation
(DCRICB)
Compliance Consultation Branch 1
(DCRICB1)
Compliance Consultation Branch 2
(DCRICB2)
Office of Integrated Food Safety Systems
Partnerships (DCRJ)
Partnerships Services Staff (DCRJ1)
Office of Domestic Partnerships (DCRJA)
Division of Domestic Partnership
Coordination and Integration
(DCRJAA)
Domestic Partnership Coordination and
Integration Branch 1 (DCRJAA1)
Domestic Partnership Coordination and
Integration Branch 2 (DCRJAA2)
Division of Domestic Partnership
Investments (DCRJAB)
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Human and Animal Branch (DCRJAB1)
Laboratory and Innovation Branch
(DCRJAB2)
Produce Branch (DCRJAB3)
Office of Retailed Food Protection
(DCRJB)
Division of Retail Food Protection
Policy, Research, and Risk
Assessment (DCRJBA)
Retail Food Protection Branch 1
(DCRJBA1)
Retail Food Protection Branch 2
(DCRJBA2)
Division of Retail Food Protection
Implementation (DCRJBB)
Retail Food Protection Implementation
Branch 1 (DCRJBB1)
Retail Food Protection Implementation
Branch 2 (DCRJBB2)
Retail Food Protection Implementation
Branch 3 (DCRJBB3)
Office of Food Chemical Safety, Dietary
Supplements, and Innovation (DCRK)
Operations Staff (DCRK1)
Innovative Foods Staff (DCRK2)
Office of Pre-Market Additive Safety
(DCRKA)
Division of Food Ingredients (DCRKAA)
Toxicology Review Branch (DCRKAA1)
Chemistry Evaluation Branch
(DCRKAA2)
Regulatory Management Branch
(DCRKAA3)
Division of Food Contact Substances
(DCRKAB)
Toxicology Review Branch (DCRKAB1)
Chemistry Evaluation Branch
(DCRKAB2)
Regulatory Management Branch
(DCRKAB3)
Office of Post-Market Assessment
(DCRKB)
Division of Chemical Contaminants
(DCRKBA)
Division of Additives and Ingredients
(DCRKBB)
Hazard Assessment and Analytics
Branch (DCRKBB1)
Regulatory Management Branch
(DCRKBB2)
Office of Dietary Supplement Programs
(DCRKC)
Division of Policy and Regulatory
Operations (DCRKCA)
Regulatory Operations Branch
(DCRKCA1)
Policy and Communications Branch
(DCRKCA2)
Division of Research and Evaluation
(DCRKCB)
Identity and Status Branch (DCRKCB1)
Safety Evaluation Branch (DCRKCB2)
Nutrition Center of Excellence (DCRL)
Office of Nutrition and Food Labeling
(DCRLA)
Division of Food Labeling and
Standards (DCRLAA)
Labeling Regulations Implementation
Branch (DCRLAA1)
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Product Evaluation and Labeling Branch
1 (DCRLAA2)
Product Evaluation and Labeling Branch
2 (DCRLAA3)
Division of Nutrition Labeling, Science
and Claims (DCRLAB)
Nutrition Assessment and Evaluation
Branch (DCRLAB1)
Nutrition Science Review Branch
(DCRLAB2)
Office of Critical Foods (DCRLB)
Infant Formula Pre-Market Review Staff
(DCRLB1)
Office of Laboratory Operations and
Applied Science (DCRM)
Office of Regulatory Testing and
Surveillance (DCRMA)
Division of Science Program
Coordination (DCRMAA)
Microbiology Branch (DCRMAA1)
Chemistry Branch (DCRMAA2)
Arkansas Human and Animal Food
Laboratory (DCRMAB)
Arkansas Chemistry Branch
(DCRMAB1)
Arkansas Microbiology Branch
(DCRMAB2)
Atlanta Human and Animal Food
Laboratory (DCRMAC)
Atlanta Chemistry Branch (DCRMAC1)
Atlanta Microbiology Branch
(DCRMAC2)
Atlanta Nutrient Analysis Branch
(DCRMAC3)
Denver Human and Animal Food
Laboratory (DCRMAD)
Denver Chemistry Branch (DCRMAD1)
Denver Microbiology Branch
(DCRMAD2)
Irvine Human and Animal Food
Laboratory (DCRMAE)
Irvine Chemistry Branch (DCRMAE1)
Irvine Microbiology Branch (DCRMAE2)
Kansas City Human and Animal Food
Laboratory (DCRMAF)
Kansas City Chemistry Branch 1
(DCRMAF1)
Kansas City Chemistry Branch 2
(DCRMAF2)
New York Human and Animal Food
Laboratory (DCRMAG)
New York Chemistry Branch
(DCRMAG1)
New York Microbiological Branch
(DCRMAG2)
San Francisco Human and Animal Food
Laboratory (DCRMAH)
San Francisco Chemistry Branch
(DCRMAH1)
San Francisco Microbiology Branch
(DCRMAH2)
Seattle Human and Animal Food
Laboratory (DCRMAI)
Seattle Chemistry Branch (DCRMAI1)
Seattle Microbiology Branch (DCRMAI2)
Office of Applied Microbiology and
Technology (DCRMB)
Division of Food and Environmental
Safety (DCRMBA)
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Environmental Microbiology Branch
(DCRMBA1)
Virology and Parasitology Branch
(DCRMBA2)
Microbial Methods Development Branch
(DCRMBA3)
Division of Food Safety Genomics
(DCRMBB)
Genomics Development and
Application Branch (DCRMBB1)
Metagenomic Diversity and Ecology
Branch (DCRMBB2)
Molecular Genetic Methods Branch
(DCRMBB3)
Division of Food Processing Science and
Technology (DCRMBC)
Chemistry and Process Engineering
Branch (DCRMBC1)
Microbiology and Food Technology
Branch (DCRMBC2)
Division of Seafood Science and
Technology (DCRMBD)
Chemical Hazards Science Branch
(DCRMBD1)
Microbiological Hazards Science Branch
(DCRMBD2)
Office of Chemistry and Toxicology
(DCRMC)
Division of Analytical Chemistry
(DCRMCA)
Method Development Branch
(DCRMCA1)
Spectroscopy and Mass Spectrometry
Branch (DCRMCA2)
Division of Bioanalytical Chemistry
(DCRMCB)
Bioanalytical Methods Branch
(DCRMCB1)
Chemical Contaminants Branch
(DCRMCB2)
Division of Toxicology (DCRMCC)
Predictive Toxicology Branch
(DCRMCC1)
Systems Toxicology Branch (DCRMCC2)
Office of Scientific Coordination and
Computational Sciences (DCRMD)
Senior Science Advisor Staff (DCRMD1)
Research Coordination Staff (DCRMD2)
GenomeTrakr and Computational
Science Staff (DCRMD3)
Office of Quality Assessment and
Management (DCRN)
Quality Assessment Staff (DCRN1)
Quality Management Staff (DCRN2)
Office of Microbiological Food Safety
(DCRO)
Operations Staff (DCRO1)
Office of Dairy and Seafood Safety
(DCROA)
Division of Dairy Safety (DCROAA)
Dairy Safety Policy Branch (DCROAA1)
Egg, Meat, and Laboratory Policy Branch
(DCROAA2)
Dairy Operations East Branch
(DCROAA3)
Dairy Operations West Branch
(DCROAA4)
Division of Seafood Safety (DCROAB)
Shellfish and Aquaculture Policy
Branch (DCROAB1)
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Seafood Processing and Technology
Policy Branch (DCROAB2)
Shellfish Operations Branch 1
(DCROAB3)
Shellfish Operations Branch 2
(DCROAB4)
Office of Produce Safety (DCROB)
Division of Fresh Produce Safety
(DCROBA)
Fresh Produce Policy Branch
(DCROBA1)
Produce Safety Engagement Branch
(DCROBA2)
Division of Processed Food and
Beverages Safety (DCROBB)
Processed Food and Beverages Policy
Branch (DCROBB1)
Processed Produce Policy Branch
(DCROBB2)
DCS. ORGANIZATION. The Office of
Inspections and Investigations is headed
by the Associate Commissioner for
Inspections and Investigations, and
includes the following organizational
units:
Office of Inspections and Investigations
(DCS)
Office of the Associate Commissioner
for Inspections and Investigations
(DCSA)
Division of Organizational
Communication and Engagement
(DCSAA)
Strategic Communication Staff
(DCSAA1)
Executive Secretariat Staff (DCSAA2)
Office of Management (DCSB)
Office of Budget, Facilities and Travel
Support (DCSBA)
Division of Financial Operations
(DCSBAA)
Human and Animal Food Budget
Execution Branch (DCSBAA1)
Budget Formulation Branch (DCSBAA2)
Medical Products and Tobacco Budget
Execution Branch (DCSBAA3)
Division of Facilities and Property
Management (DCSBAB)
Real Property Branch 1 (DCSBAB1)
Real Property Branch 2 (DCSBAB2)
Real Property Branch 3 (DCSBAB3)
Fleet and Personal Property
Management Branch (DCSBAB4)
Real Property Branch 4 (DCSBAB5)
Real Property Branch 5 (DCSBAB6)
Real Property Branch 6 (DCSBAB7)
Division of Contracts and Grants
(DCSBAC)
Operational Contracts and Agreements
Branch 1 (DCSBAC1)
Operational Contracts and Agreements
Branch 2 (DCSBAC2)
Division of Travel Operations
(DCSBAD)
Domestic Travel Branch (DCSBAD1)
Foreign Travel Branch 1 (DCSBAD2)
Foreign Travel Branch 2 (DCSBAD3)
Foreign Travel Branch 3 (DCSBAD4)
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Foreign Travel Branch 4 (DCSBAD5)
Office of Workforce Management
(DCSBB)
Executive and Scientific Resource Staff
(DCSBB1)
Division of Human Capital Staffing
Services (DCSBBA)
Talent Acquisition Branch 1 (DCSBBA1)
Talent Acquisition Branch 2 (DCSBBA2)
Talent Acquisition Branch 3 (DCSBBA3)
Division of Human Capital Programs
(DCSBBB)
Performance Management and
Engagement Branch (DCSBBB1)
Management Analysis Branch
(DCSBBB2)
Office of Animal Food Inspectorate
(DCSC)
Division of Animal Food Inspectorate I
(DCSCA)
Animal Food Investigations Branch 1
(DCSCA1)
Animal Food Investigations Branch 2
(DCSCA2)
Animal Food Investigations Branch 3
(DCSCA3)
Division of Animal Food Inspectorate II
(DCSCB)
Animal Food Investigations Branch 1
(DCSCB1)
Animal Food Investigations Branch 2
(DCSCB2)
Animal Food Investigations Branch 3
(DCSCB3)
Office of Biologics Inspectorate (DCSD)
Biologics Global Operations Staff
(DCSD1)
Division of Biologics Inspectorate I
(DCSDB)
Biologics Investigations Branch 1
(DCSDB1)
Biologics Investigations Branch 2
(DCSDB2)
Biologics Investigations Branch 3
(DCSDB3)
Biologics Investigations Branch 4
(DCSDB4)
Division of Biologics Inspectorate II
(DCSDC)
Biologics Investigations Branch 1
(DCSDC1)
Biologics Investigations Branch 2
(DCSDC2)
Biologics Investigations Branch 3
(DCSDC3)
Division of Biologics Inspectorate III
(DCSDD)
Biologics Investigations Branch 1
(DCSDD1)
Biologics Investigations Branch 2
(DCSDD2)
Biologics Investigations Branch 3
(DCSDD3)
Division of Biotechnology Inspectorate
(DCSDE)
Biotechnology Investigations Branch 1
(DCSDE1)
Biotechnology Investigations Branch 2
(DCSDE2)
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Office of Bioresearch Monitoring
Inspectorate (DCSE)
Division of Bioresearch Monitoring
Global Operations (DCSEA)
Bioresearch Monitoring Foreign
Investigations Branch 1 (DCSEA1)
Bioresearch Monitoring Foreign
Investigations Branch 2 (DCSEA2)
Bioresearch Monitoring Inspectorate
Expert Support Branch (DCSEA3)
Division of Bioresearch Monitoring
Inspectorate I (DCSEB)
Bioresearch Monitoring Investigations
Branch 1 (DCSEB1)
Bioresearch Monitoring Investigations
Branch 2 (DCSEB2)
Bioresearch Monitoring Investigations
Branch 3 (DCSEB3)
Bioresearch Monitoring Investigations
Branch 4 (DCSEB4)
Division of Bioresearch Monitoring
Inspectorate II (DCSEC)
Bioresearch Monitoring Investigations
Branch 1 (DCSEC1)
Bioresearch Monitoring Investigations
Branch 2 (DCSEC2)
Bioresearch Monitoring Investigations
Branch 3 (DCSEC3)
Division of Bioresearch Monitoring
Inspectorate III (DCSED)
Bioresearch Monitoring Investigations
Branch 1 (DCSED1)
Bioresearch Monitoring Investigations
Branch 2 (DCSED2)
Bioresearch Monitoring Investigations
Branch 3 (DCSED3)
Division of Bioresearch Monitoring
Inspectorate IV (DCSEF)
Bioresearch Monitoring Investigations
Branch 1 (DCSEF1)
Bioresearch Monitoring Investigations
Branch 2 (DCSEF2)
Bioresearch Monitoring Investigations
Branch 3 (DCSEF3)
Office of Business Informatics and
Solutions Management (DCSF)
Division of Import Business Informatics
and Solutions (DCSFB)
Import Business Informatics Branch
(DCSFB1)
Import Business Solutions Branch
(DCSFB2)
Division of Regulatory Business
Informatics and Solutions (DCSFC)
Regulatory Business Informatics Branch
(DCSFC1)
Regulatory Business Solutions Branch
(DCSFC2)
Division of Solutions Planning,
Management and Governance
(DCSFD)
Integrated Management and Investments
Branch (DCSFD1)
Program Solutions and Services Branch
(DCSFD2)
Division of Work Planning and
Analytics (DCSFE)
Work Planning and Analytics Branch
(DCSFE1)
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Informatics and Process Quality Branch
(DCSFE2)
Office of Criminal Investigations (DCSG)
Metro Washington Field Office (DCSGA)
Philadelphia Resident Unit (DCSGA1)
Chicago Field Office (DCSGB)
New York Field Office (DCSGC)
Boston, MA Resident Unit (DCSGC1)
Los Angeles Field Office (DCSGD)
San Francisco, CA Resident Unit
(DCSGD1)
Miami Field Office (DCSGE)
San Juan, PR Resident Unit (DCSGE1)
Atlanta, GA Resident Unit (DCSGE2)
New Orleans, LA Resident Unit
(DCSGE3)
Kansas City Field Office (DCSGF)
Dallas, TX Resident Unit (DCSGF1)
Office of Field Operations and Response
(DCSH)
Organizational Quality Staff (DCSH1)
Office of Field Regulatory Operations
(DCSHA)
Division of Field Enforcement
(DCSHAA)
Health Fraud Inspectorate Branch
(DCSHAA1)
Field Recall Effectiveness Branch
(DCSHAA2)
Division of Inspectorate Policy
(DCSHAB)
Food Inspectorate Policy Branch
(DCSHAB1)
Medical Products and Tobacco
Inspectorate Policy Branch
(DCSHAB2)
Division of Tobacco Inspectorate
(DCSHAC)
Tobacco Investigations Branch 1
(DCSHAC1)
Tobacco Investigations Branch 2
(DCSHAC2)
Office of Emergency Response (DCSHB)
Division of Emergency Response
(DCSHBA)
Field Emergency Response Coordinators
Branch 1 (DCSHBA1)
Field Emergency Response Coordinators
Branch 2 (DCSHBA2)
Incident Coordination Branch
(DCSHBA3)
Division of Emergency Preparedness
and Support (DCSHBB)
Emergency Planning, Exercises and
Evaluation Branch (DCSHBB2)
Program Operations and Coordination
Branch (DCSHBB3)
Office of Training, Education, and
Development (DCSI)
Division of Programmatic Training
(DCSIA)
Programmatic Training Branch 1
(DCSIA1)
Programmatic Training Branch 2
(DCSIA2)
Division of Multi-Program, Leadership,
and Management Training (DCSIB)
Multi-Program, Leadership, and
Management Branch (DCSIB1)
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Leadership, Management, and
Mentoring Training Branch (DCSIB2)
Division of Instructional Systems and
Technology (DCSIC)
Instructional Systems Branch (DCSIC1)
Learning Management Technology and
Multimedia Branch (DCSIC2)
Certification Branch (DCSIC3)
Office of Human and Animal Drug
Inspectorate (DCSJ)
Division of Human and Animal Drug
Foreign Inspectorate (DCSJA)
Human and Animal Drug Foreign
Investigations Branch 1 (DCSJA1)
Human and Animal Drug Foreign
Investigations Branch 2 (DCSJA2)
Human and Animal Drug Foreign
Operations Branch (DCSJA3)
Division of Human and Animal Drug
Global Operations (DCSJB)
Human and Animal Drug Program
Operations Branch (DCSJB1)
Human and Animal Drug Mutual
Recognition Branch (DCSJB2)
Division of Human and Animal Drug
Inspectorate I (DCSJC)
Human and Animal Drug Investigations
Branch 1 (DCSJC1)
Human and Animal Drug Investigations
Branch 2 (DCSJC2)
Human and Animal Drug Investigations
Branch 3 (DCSJC3)
Human and Animal Drug Investigations
Branch 4 (DCSJC4)
Human and Animal Drug Investigations
Branch 5 (DCSJC5)
Division of Human and Animal Drug
Inspectorate II (DCSJD)
Human and Animal Drug Investigations
Branch 1 (DCSJD1)
Human and Animal Drug Investigations
Branch 2 (DCSJD2)
Human and Animal Drug Investigations
Branch 3 (DCSJD3)
Human and Animal Drug Investigations
Branch 4 (DCSJD4)
Human and Animal Drug Investigations
Branch 5 (DCSJD5)
Division of Human and Animal Drug
Inspectorate III (DCSJE)
Human and Animal Drug Investigations
Branch 1 (DCSJE1)
Human and Animal Drug Investigations
Branch 2 (DCSJE2)
Human and Animal Drug Investigations
Branch 3 (DCSJE3)
Human and Animal Drug Investigations
Branch 4 (DCSJE4)
Human and Animal Drug Investigations
Branch 5 (DCSJE5)
Division of Human and Animal Drug
Inspectorate IV (DCSJF)
Human and Animal Drug Investigations
Branch 1 (DCSJF1)
Human and Animal Drug Investigations
Branch 2 (DCSJF2)
Human and Animal Drug Investigations
Branch 3 (DCSJF3)
Human and Animal Drug Investigations
Branch 4 (DCSJF4)
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Human and Animal Drug Investigations
Branch 5 (DCSJF5)
Division of Human and Animal Drug
Inspectorate V (DCSJG)
Human and Animal Drug Investigations
Branch 1 (DCSJG1)
Human and Animal Drug Investigations
Branch 2 (DCSJG2)
Human and Animal Drug Investigations
Branch 3 (DCSJG3)
Human and Animal Drug Investigations
Branch 4 (DCSJG4)
Human and Animal Drug Investigations
Branch 5 (DCSJG5)
Division of Human and Animal Drug
Inspectorate VI (DCSJH)
Human and Animal Drug Investigations
Branch 1 (DCSJH1)
Human and Animal Drug Investigations
Branch 2 (DCSJH2)
Human and Animal Drug Investigations
Branch 3 (DCSJH3)
Human and Animal Drug Investigations
Branch 4 (DCSJH4)
Human and Animal Drug Investigations
Branch 5 (DCSJH5)
Office of Human Food Inspectorate
(DCSK)
Office of Human Food Inspectorate
Central (DCSKA)
Division of Human Food Inspectorate
Central I (DCSKAA)
Human Food Investigations Branch 1
(DCSKAA1)
Human Food Investigations Branch 2
(DCSKAA2)
Human Food Investigations Branch 3
(DCSKAA3)
Human Food Investigations Branch 4
(DCSKAA4)
Division of Human Food Inspectorate
Central II (DCSKAB)
Human Food Investigations Branch 1
(DCSKAB1)
Human Food Investigations Branch 2
(DCSKAB2)
Human Food Investigations Branch 3
(DCSKAB3)
Human Food Investigations Branch 4
(DCSKAB4)
Human Food Investigations Branch 5
(DCSKAB5)
Division of Human Food Inspectorate
Central III (DCSKAC)
Human Food Investigations Branch 1
(DCSKAC1)
Human Food Investigations Branch 2
(DCSKAC2)
Human Food Investigations Branch 3
(DCSKAC3)
Human Food Investigations Branch 4
(DCSKAC4)
Human Food Investigations Branch 5
(DCSKAC5)
Human Food Investigations Branch 6
(DCSKAC6)
Division of Human Food Inspectorate
Central IV (DCSKAD)
Human Food Investigations Branch 1
(DCSKAD1)
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Human Food Investigations Branch 2
(DCSKAD2)
Human Food Investigations Branch 3
(DCSKAD3)
Human Food Investigations Branch 4
(DCSKAD4)
Division of Human Food Inspectorate
Central V (DCSKAE)
Human Food Investigations Branch 1
(DCSKAE1)
Human Food Investigations Branch 2
(DCSKAE2)
Human Food Investigations Branch 3
(DCSKAE3)
Human Food Investigations Branch 4
(DCSKAE4)
Human Food Investigations Branch 5
(DCSKAE5)
Office of Human Food Inspectorate East
(DCSKB)
Division of Human Food Inspectorate
East I (DCSKBA)
Human Food Investigations Branch 1
(DCSKBA1)
Human Food Investigations Branch 2
(DCSKBA2)
Human Food Investigations Branch 3
(DCSKBA3)
Human Food Investigations Branch 4
(DCSKBA4)
Human Food Investigations Branch 5
(DCSKBA5)
Division of Human Food Inspectorate
East II (DCSKBB)
Human Food Investigations Branch 1
(DCSKBB1)
Human Food Investigations Branch 2
(DCSKBB2)
Human Food Investigations Branch 3
(DCSKBB3)
Human Food Investigations Branch 4
(DCSKBB4)
Division of Human Food Inspectorate
East III (DCSKBC)
Human Food Investigations Branch 1
(DCSKBC1)
Human Food Investigations Branch 2
(DCSKBC2)
Human Food Investigations Branch 3
(DCSKBC3)
Human Food Investigations Branch 4
(DCSKBC4)
Division of Human Food Inspectorate
East IV (DCSKBD)
Human Food Investigations Branch 1
(DCSKBD1)
Human Food Investigations Branch 2
(DCSKBD2)
Human Food Investigations Branch 3
(DCSKBD3)
Human Food Investigations Branch 4
(DCSKBD4)
Human Food Investigations Branch 5
(DCSKBD5)
Human Food Investigations Branch 6
(DCSKBD6)
Office of Human Food Inspectorate West
(DCSKC)
Division of Human Food Inspectorate
West I (DCSKCA)
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Human Food Investigations Branch 1
(DCSKCA1)
Human Food Investigations Branch 2
(DCSKCA2)
Human Food Investigations Branch 3
(DCSKCA3)
Human Food Investigations Branch 4
(DCSKCA4)
Human Food Investigations Branch 5
(DCSKCA5)
Division of Human Food Inspectorate
West II (DCSKCB)
Human Food Investigations Branch 1
(DCSKCB1)
Human Food Investigations Branch 2
(DCSKCB2)
Human Food Investigations Branch 3
(DCSKCB3)
Human Food Investigations Branch 4
(DCSKCB4)
Human Food Investigations Branch 5
(DCSKCB5)
Division of Human Food Inspectorate
West III (DCSKCC)
Human Food Investigations Branch 1
(DCSKCC1)
Human Food Investigations Branch 2
(DCSKCC2)
Human Food Investigations Branch 3
(DCSKCC3)
Human Food Investigations Branch 4
(DCSKCC4)
Division of Human Food Inspectorate
West IV (DCSKCD)
Human Food Investigations Branch 1
(DCSKCD1)
Human Food Investigations Branch 2
(DCSKCD2)
Human Food Investigations Branch 3
(DCSKCD3)
Human Food Investigations Branch 4
(DCSKCD4)
Office of Global and Specialty Human
Food Inspectorate (DCSKD)
Human Food National Expert Staff
(DCSKD1)
Division of Critical and Specialty Food
(DCSKDA)
Critical Food Investigations Branch
(DCSKDA1)
Food Defense Branch (DCSKDA2)
Human Food Program Expert Branch
(DCSKDA3)
Emerging Food and Specialty Products
Branch (DCSKDA4)
Division of Foreign Food Investigations
and Global Operations (DCSKDB)
Foreign Food Investigations Branch 1
(DCSKDB1)
Foreign Food Investigations Branch 2
(DCSKDB2)
Foreign Food Investigations Branch 3
(DCSKDB3)
Foreign Food Operations Branch
(DCSKDB4)
Foreign Food Coordination Branch
(DCSKDB5)
Division of Produce Safety (DCSKDC)
Produce Safety Branch 1 (DCSKDC1)
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Produce Safety Branch 2 (DCSKDC2)
Produce Safety Branch 3 (DCSKDC3)
Office of Import Operations (DCSL)
Division of Targeting and Analysis
(DCSLA)
Division of Import Operations (DCSLB)
Import Operations Branch (DCSLB1)
Import Compliance Branch (DCSLB2)
Division of Analysis and Program
Evaluation (DCSLC)
Program Development Branch (DCSLC1)
Import Technical Assistance Branch
(DCSLC2)
Division of Southwest Imports (DCSLD)
Southwest Import Investigations Branch
(DCSLD1)
Southwest Import Compliance Branch
(DCSLD2)
Division of Southeast Imports (DCSLE)
Southeast Import Investigations Branch
1 (DCSLE1)
Southeast Import Investigations Branch
2 (DCSLE2)
Southeast Import Compliance Branch
(DCSLE3)
Division of Northeast Imports (DCSLF)
Northeast Import Investigations Branch
(DCSLF1)
Northeast Import Compliance Branch
(DCSLF2)
Division of Northern Border Imports
(DCSLG)
Northern Border Import Investigations
Branch 1 (DCSLG1)
Northern Border Import Investigations
Branch 2 (DCSLG2)
Northern Border Import Compliance
Branch (DCSLG3)
Division of West Coast Imports (DCSLH)
West Coast Import Investigations Branch
(DCSLH1)
West Coast Import Compliance Branch
(DCSLH2)
Division of Planning and Public
Response (DCSLI)
Office of Medical Device and
Radiological Health Inspectorate
(DCSM)
Division of Mammography and
Radiological Health Inspectorate
(DCSMA)
Mammography Operations Branch 1
(DCSMA1)
Mammography Operations Branch 2
(DCSMA2)
Division of Medical Device and
Radiological Health Inspectorate I
(DCSMB)
Medical Device and Radiological Health
Investigations Branch 1 (DCSMB1)
Medical Device and Radiological Health
Investigations Branch 2 (DCSMB2)
Medical Device and Radiological Health
Investigations Branch 3 (DCSMB3)
Medical Device and Radiological Health
Investigations Branch 4 (DCSMB4)
Division of Medical Device and
Radiological Health Inspectorate II
(DCSMC)
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Medical Device and Radiological Health
Investigations Branch 1 (DCSMC1)
Medical Device and Radiological Health
Investigations Branch 2 (DCSMC2)
Medical Device and Radiological Health
Investigations Branch 3 (DCSMC3)
Medical Device and Radiological Health
Investigations Branch 4 (DCSMC4)
Medical Device and Radiological Health
Investigations Branch 5 (DCSMC5)
Division of Medical Device and
Radiological Health Inspectorate III
(DCSMD)
Medical Device and Radiological Health
Investigations Branch 1 (DCSMD1)
Medical Device and Radiological Health
Investigations Branch 2 (DCSMD2)
Medical Device and Radiological Health
Investigations Branch 3 (DCSMD3)
Medical Device and Radiological Health
Investigations Branch 4 (DCSMD4)
Medical Device and Radiological Health
Investigations Branch 5 (DCSMD5)
Division of Medical Device and
Radiological Health Global Operations
(DCSME)
Medical Device and Radiological Health
Foreign Operations Branch (DCSME1)
Medical Device and Radiological Health
Operations Branch (DCSME2)
Medical Device and Radiological Health
Risk Mitigation and Response Branch
(DCSME3)
Division of Medical Device and
Radiological Health Inspectorate IV
(DCSMF)
Medical Device and Radiological Health
Investigations Branch 1 (DCSMF1)
Medical Device and Radiological Health
Investigations Branch 2 (DCSMF2)
Medical Device and Radiological Health
Investigations Branch 3 (DCSMF3)
Medical Device and Radiological Health
Investigations Branch 4 (DCSMF4)
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.
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Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2024–11893 Filed 5–30–24; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5345]
Michael Terry Little: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Michael Terry Little for a period of 5
years from importing or offering for
import any drug into the United States.
FDA bases this order on a finding that
Mr. Little was convicted of one felony
count under Federal law for
introduction of unapproved new drugs
in interstate commerce. The factual
basis supporting Mr. Little’s conviction,
as described below, is conduct relating
to the importation into the United States
of a drug or controlled substance. Mr.
Little was given notice of the proposed
debarment and was given an
opportunity to request a hearing to show
why he should not be debarred. As of
March 13, 2024 (30 days after receipt of
the notice), Mr. Little had not
responded. Mr. Little’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable June 3,
2024.
ADDRESSES: Any application by Mr.
Little for termination of debarment
under section 306(d)(1) of the FD&C Act
(21 U.S.C. 335a(d)(1)) may be submitted
at any time as follows:
SUMMARY:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\03JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47567-47576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11893]
-----------------------------------------------------------------------
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.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Office of the
Commissioner, Headquarters organizations, and Centers have modified
their organizational structure
DATES: This organization was approved by the Secretary of Health and
Human Services on March 5, 2024, and became effective on May 13, 2024.
FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of
Planning, Evaluation, and Risk Management, Office of the Finance,
Budget, Acquisitions and Planning, Food and Drug Administration, 10903
New Hampshire Avenue, WO32, Room 4216, Silver Spring, MD 20993, 301-
796-4710.
SUPPLEMENTARY INFORMATION: 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 approved Food and Drug Administration's
Human Foods reorganization.
[[Page 47568]]
The Food and Drug Administration (FDA) is focused on transforming
its organization structure to be more efficient, nimble, and ready for
the future with the ever-changing and complex industries we regulate,
including the emergence of new food and medical product technologies,
the impacts of globalization, climate change and other factors that
require FDA to quickly adapt to a consistently evolving world.
FDA carefully reviewed the findings and recommendations of the
Reagan-Udall Foundation evaluation, an internal review of FDA's infant
formula response and feedback from external and internal stakeholders
during events such as listening sessions with FDA employees. The
approved changes in the Human Foods Program (HFP) would allow us to
fully realize the preventive vision laid out in the FDA Food Safety
Modernization Act, elevate the importance of nutrition, strengthen
local, state, and international partnerships, position the FDA to
regulate innovative food and agricultural products more effectively,
and uphold safety of the nation's food supply. The organizational
changes impact other products that FDA regulates, such as medical
products and cosmetics, by promoting more streamlined, efficient
decision-making and strengthening the enterprise-wide structure to
enhance collaboration across FDA.
The intent is to have a modernized FDA that optimizes resources to
help the agency meet its public health mission; provide employees with
clearer priorities and more career opportunities; and comply with
recent legislation such as the Food and Drug Omnibus Reform Act of 2022
(FDORA) mandating the establishment of the Office of Critical Foods,
and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to
ensure the safety of cosmetics products.
The reorganization establishes the HFP by realigning the functions
of the Center for Food Safety and Applied Nutrition (CFSAN), Office of
Food Policy and Response, as well as key functions from the Office of
Regulatory Affairs (ORA) including human foods compliance, Human and
Animal Food Laboratories, and State Partnerships to this new
organization. The reorganization will also:
Realign ORA's compliance functions to Center for Biologics
Evaluation and Research's Office of Compliance and Biologics Quality,
Center for Devices and Radiological Health's Office of Product
Evaluation and Quality, Center for Drug Evaluation and Research's
Office of Compliance and its substructure organizations, and the Center
for Veterinary Medicine's Office of Surveillance and Compliance.
Realign ORA's laboratory safety functions and resources as well as
the Medical Product and Specialty Laboratories safety functions and
resources to the Office of the Chief Scientist.
Retitle ORA to the Office of Inspections and Investigations (OII)
and establish new inspection and investigation offices to focus on
inspections, investigations, and imports as its core mission.
Realign emergency response functions and resources from the Office
of Operations' Office of Security and Emergency Management to OII.
Realign select functions to strengthen the Office of the
Commissioner (OC) and headquarter organizations, including:
Establish, within OC immediate organization, the Office of
Enterprise Transformation to focus on key information technology
transformation projects across FDA.
Realign the Office of Planning, Evaluation and Risk Management,
within OC immediate organization, to focus on strategic initiatives for
FDA.
Retitle the Office of Clinical Policy and Programs and realign
functions to form the Office of the Chief Medical Officer.
Retitle the Office of External Affairs' Stakeholder Engagement
Staff to Public Engagement Staff.
Realign select functions to strengthen the Office of Operations
(OO) and substructure organizations, including:
Realign the Office of Executive Secretariat's Freedom of
Information Staff functions and resources from the OC's Immediate
Office to OO's Office of Enterprise Management Services (OEMS) to
consolidate and streamline information disclosure operations.
Retitle OO's OEMS to the Office of Management and Enterprise
Services (OMES). Restructure the organization by establishing two
office level organizations: the Office of Disclosure, Information
Governance, and Accessibility (ODIGA) and the Office of Management (OM)
and substructure organizational components within OMES.
Retitle OO's Office of Security and Emergency Management (OSEM) to
the Office of Security and Passport Operations (OSPO). Abolish the
substructure organizations, and establish the Division of Personnel
Security and Credentialing, the Division of Physical Security and
Integration, and the Division of Resource Integration and Passport
Operations.
Retitle OO's Office of Finance, Budget, Acquisitions and Planning
(OFBAP) to the Office of Finance, Budget, and Acquisitions (OFBA).
Realign travel functions and resources from ORA to the Office of
Financial Management within OFBA.
Abolish OO's Office of Facilities Engineering and Mission Support
Services' (OFEMS) Employee Safety and Occupational Health Staff (ESOHS)
and realign emergency safety and occupational health functions from
OFEMS to the Office of the Chief Scientist (OCS).
Realign select functions to strengthen the OCS and substructure
organizations, as follows:
Establish an Administrative Staff organizational component and
realign functions and resources from within the immediate organization
into this new component.
Realign the Informatics and Business Operations Staff from the ORA
Office of Regulatory Science to the OCS immediate organization.
Merge the Office of Counter-Terrorism and Emerging Threats, and the
Office of Regulatory Science and Innovation, to form the Office of
Regulatory and Emerging Science. Establish the Communications and
Outreach Staff, the Preparedness Research Staff and the Regulatory
Science Staff to this new organization.
Merge the Office of Laboratory Safety and OO's ESOH within OFEMS to
the organization titled as the Office of Occupational Safety and Health
(OOSH). Within the OOSH, merge the functions of the former OO ESOH with
those of the OCS Office of Laboratory Safety, and establish the
Occupational Safety Staff and the Occupational Health Services Staff to
this new organizational component.
Realign the Office of Cosmetics and Colors organization, including
its Divisions and Branches, functions and resources, from CFSAN to OCS.
Establish the Office of Analytical and Regulatory Laboratories and
realign resources from the ORA Office of Medical Products Laboratory
Operations and substructure organizations, and realign functions from
within the CFSAN Office of Regulatory Science to this new organization
which will be a direct report to OCS.
Establish the Office of Specialty Laboratories and Enforcement
Support and realign functions from the ORA's Office of Medical Products
Laboratory Operations within the Office of Regulatory Science to this
new organization which will be a direct report to OCS.
[[Page 47569]]
Establish the Office of Science and Laboratory Advancement and
realign functions from ORA's Office of Safety within the Office of
Regulatory Science to this new organization which will be a direct
report to OCS.
DCA. ORGANIZATION. To reflect these changes, Part D, Section D-B,
is replaced with the following:
The Office of the Commissioner is headed by the Commissioner of
Food and Drugs, and includes the following organizational units:
Office of the Commissioner (DCA)
Office of the Chief Counsel (DCAA)
Office of the Executive Secretariat (DCAB)
Office of the Counselor to the Commissioner (DCAC)
Office of Digital Transformation (DCAD)
Strategy and Operations Staff (DCAD1)
Office of Information Management and Technology (DCADA)
Office of Technology and Delivery (DCADAA)
Delivery Management Support Staff (DCADAA1)
Division of Infrastructure Operations (DCADAAA)
Infrastructure Management Services Staff (DCADAAA1)
Implementation Branch (DCADAAA2)
Infrastructure Engineering Branch (DCADAAA3)
Systems Monitoring and Response Branch (DCADAAA4)
Systems Operations Branch (DCADAAA5)
Network and Communications Operations Branch (DCADAAA6)
Division of Application Services (DCADAAB)
Application Management Services Staff (DCADAAB1)
Data Management and Operations Branch (DCADAAB2)
Medical Products Branch (DCADAAB3)
OC, CVM, CTP Branch (DCADAAB4)
ORA, CFSAN Branch (DCADAAB5)
Enterprise Application Branch (DCADAAB6)
Office of Business and Customer Assurance (DCADAB)
Division of Business Partnership and Support (DCADABA)
Internet and Intranet Branch (DCADABA1)
Call Center Branch (DCADABA2)
Regional Support Branch (DCADABA3)
Property Receiving and Distribution Branch (DCADABA4)
Employee Resource and Information Center (DCADABA5)
Division of Management Services (DCADABB)
Office of Enterprise Portfolio Management (DCADAC)
Office of Information Security (DCADB)
Office of Data Analytics and Research (DCADC)
Data Staff (DCADC1)
Health Informatics Staff (DCADC2)
Knowledge Management Staff (DCADC3)
Office of Enterprise Transformation (DCAE)
Office of Planning, Evaluation, and Risk Management (DCAG)
Administrative Staff (DCAG1)
Strategic Planning and Change Management Staff (DCAG2)
Evaluation and Analytics Staff (DCAG3)
Enterprise Risk Management Staff (DCAG4)
Performance Management Staff (DCAG5)
DCBC. ORGANIZATION. The Office of Compliance and Biologics Quality
within the Center for Biologics Evaluation and Research is headed by
the Director for Compliance and Biologics Quality and includes the
following organizational units:
Office of Compliance and Biologics Quality (DCBC)
Division of Case Management (DCBCA)
Blood and Tissue Compliance Branch (DCBCA1)
Advertising and Promotional Labeling Branch (DCBCA2)
Biological Drug and Device Compliance Branch 1 (DCBCA3)
Biological Drug and Device Compliance Branch 2 (DCBCA4)
Division of Inspections and Surveillance (DCBCB)
Program Surveillance Branch (DCBCB1)
Bioresearch Monitoring Branch (DCBCB2)
Field Surveillance Branch (DCBCB3)
Division of Manufacturing and Product Quality (DCBCC)
Product Release Branch (DCBCC1)
Manufacturing Review Branch 1 (DCBCC2)
Manufacturing Review Branch 2 (DCBCC3)
Manufacturing Review Branch 3 (DCBCC4)
Applications Review Branch (DCBCC5)
Division of Biological Standards and Quality Control (DCBCD)
Quality Assurance Branch (DCBCD2)
Laboratory of Microbiology, In-Vivo Testing and Standards Branch
(DCBCD3)
Laboratory of Analytical Chemistry (DCBCD4)
Laboratory of Biochemistry, Virology, and Immunochemistry Branch
(DCBCD5)
Laboratory of Blood Related Products Branch (DCBCD6)
DCDF. ORGANIZATION. The Office of Compliance within the Center for
Drug Evaluation and Research is headed by the Director for Compliance
and includes the following organization units:
Office of Compliance (DCDF)
Program Management and Analysis Staff (DCDF1)
Office of Manufacturing Quality (DCDFA)
Manufacturing Guidance and Policy Staff (DCDFA1)
Regulatory Compliance and Analysis Staff (DCDFA2)
Division of Drug Quality I (DCDFAA)
Division of Drug Quality II (DCDFAB)
Division of Drug Quality III (DCDFD)
Office of Unapproved Drugs and Labeling Compliance (DCDFB)
Division of Unapproved New Drugs and Labeling (DCDFBB)
Fraud Drugs Branch (DCDFBB2)
Prescription Drugs Branch (DCDFBB3)
Division of Labeling, Regulation, Regulation and Unapproved Drugs
(DCDFBC)
Over-The-Counter Drug Branch (DCDFBC1)
Drug Registration and Listing Branch (DCDFBC2)
Office of Scientific Investigations (DCDFC)
Policy Staff (DCDFC1)
Division of Good Clinical Practice Compliance (DCDFCA)
Good Clinical Practice Enforcement Branch (DCDFCA1)
Good Clinical Practice Assessment Branch (DCDFCA2)
Division of Safety Compliance (DCDFCB)
Division of Enforcement and Post-market Safety (DCDFCC)
Compliance Enforcement Branch (DCDFCC1)
Post-marketing Safety Branch (DCDFCC2)
Division of Clinical Compliance Evaluation (DCDFCD)
Good Clinical Practice Compliance Oversight Branch DCDFCD1)
Good Clinical Practice Assessment Branch (DCDFCD2)
Office of Drug Security Integrity and Response (DCDFD)
Division of Global Drug Distribution and Policy (DCDFDA)
Imports Compliance Branch (DCDFDA3)
Exports Compliance Branch (DCDFDA4)
Division of Supply Chain Integrity (DCDFDB)
Incidents, Recalls, and Shortage Branch (DCDFDB3)
Supply Chain Security Branch (DCDFDB4)
Office of Program and Regulatory Operations (DCDFE)
Program and Regulatory Operations Staff 1 (DCDFE1)
Program and Regulatory Operations Staff 2 (DCDFE2)
[[Page 47570]]
Project Management and Coordination Staff 3 (DCDFE4)
Office of Compounding Quality and Compliance (DCDFF)
Division of Compounding I (DCDFFA)
Compounding Branch 1 (DCDFFA1)
Compounding Branch 2 (DCDFFA2)
Compounding Branch 3 (DCDFFA3)
Division of Compounding II (DCDFFB)
Compounding Branch 4 (DCDFFB2)
Compounding Branch 5 (DCDFFB3)
Compounding Branch 6 (DCDFFB4)
Division of Compounding Policy and Outreach (DCDFFC)
Compounding Branch 7 (DCDFFC3)
Compounding Branch 8 (DCDFFC4)
DCGD. ORGANIZATION. The Office of Surveillance and Compliance
within the Center for Veterinary Medicine is headed by the Director of
Surveillance and Compliance and includes the following organization
units:
Office of Surveillance and Compliance (DCGD)
Regulatory Counsel Staff (DCGD1)
Business Management and Operations Staff (DCGD2)
Division of Pharmacovigilance and Surveillance (DCGDA)
Marketed Product Information Branch (DCGDA1)
Food Animal, BioPharm, Small Animal Antiparasitics and Endectocides
Branch (DCGDA2)
Small Animal Antibiotics/Anesthectics/NSAIDS/Oncology/Others Branch
(DCGDA3)
Division of Animal Food Ingredients (DCGDB)
Program-Business Branch (DCGDB1)
Biotechnology Branch (DCGDB2)
Chemistry Manufacturing and Controls (CMC) Tech Additives Branch
(DCGDB3)
Nutrients Claims Branch (DCGDB4)
Division of Drug Compliance (DCGDC)
Drug and Devices--Veterinary Medical Support Branch (DCGDC1)
Drug and Devices-Compliance Support Branch (DCGDC2)
Bioresearch Monitoring (BIMO) and Current Good Manufacturing Practice
(CGMP) Branch (DCGDC3)
Division of Food Compliance (DCGDE)
Complaints, Emergencies, and Recall Team (CERT) Branch (DCGDE1)
Field Operations and Investigations Branch (DCGDE2)
Regulatory Policy and Program Branch (DCGDE3)
Science Policy Branch (DCGDE4)
Compliance Action Branch (DCGDE5)
DCJ. ORGANIZATION. The Office of the Chief Medical Officer is
headed by the Chief Medical Officer, and includes the following
organization units:
Office of the Chief Medical Officer (DCJ)
Office of Clinical Policy (DCJA)
Office of Combination Products (DCJB)
Office of Orphan Products Development (DCJC)
Office of Pediatric Therapeutics (DCJD)
Office of Public Health Preparedness and Response (DCJE)
DCK. ORGANIZATION. The Office of External Affairs is headed by the
Associate Commissioner for External Affairs, and includes the following
organization units:
Office of External Affairs (DCK)
Operations Staff (DCK1)
Public Engagement Staff (DCK3)
Web and Digital Services Staff (DCK4)
Office of Editorial and Creative Services (DCKA)
Office of Media Affairs (DCKB)
DCN. ORGANIZATION. The Office of Operations is headed by the Deputy
Commissioner for Operations and Chief Operations Officer and includes
the following organization units:
Office of Operations (DCN)
Office of Management and Enterprise Services (DCNA)
Office of Disclosure, Information Governance, and Accessibility (DCNAF)
Division of Information Governance (DCNAFA)
eDiscovery Branch (DCNAFA1)
Records Management Branch (DCNAFA2)
Paperwork Reduction Act Branch (DCNAFA3)
Privacy Branch (DCNAFA4)
Dockets Management Branch (DCNAFA5)
Division of Information Disclosure (DCNAFB)
Freedom of Information Branch (DCNAFB1)
Disclosure Branch (DCNAFB2)
Division of Headquarters Freedom of Information (DCNAFC)
Division of Conflict Prevention, and Accessibility (DCNAFD)
Conflict Prevention and Resolution Branch (DCNAFD1)
Reasonable Accommodations Branch (DCNAFD2)
Office of Management (DCNAG)
Division of Resources Management (DCNAGA)
Office of the Commissioner Resource Management Branch (DCNAGA1)
Global Policy and Strategy Resource Management Branch (DCNAGA2)
Division of Human Capital (DCNAGB)
Human Capital Management Branch (DCNAGB1)
Human Capital Programs Branch (DCNAGB2)
Division of Acquisitions Management (DCNAGC)
Acquisitions Management Branch (DCNAGC1)
Acquisitions Support Branch (DCNAGC2)
Division of Management Services (DCNAGD)
Communications Branch (DCNAGD1)
Governance Branch (DCNAGD2)
Office of Ethics and Integrity (DCNB)
Office of Equal Employment Opportunity (DCNC)
Compliance Staff (DCNC1)
Office of Finance, Budget, and Acquisitions (DCNE)
Business Management Services Staff (DCNE1)
Office of Budget (DCNEA)
Division of Budget Formulation (DCNEAA)
Division of Budget Execution and Control (DCNEAB)
Division of Reorganizations and Delegations of Authority (DCNEAC)
Office of Acquisitions and Grants Services (DCNEB)
Training and Development Staff (DCNEB1)
Division of Acquisition Operations (DCNEBA)
Service Contracts Branch (DCNEBA1)
Contracts Operations Branch (DCNEBA2)
Scientific Support Branch (DCNEBA3)
Division of Acquisition Programs (DCNEBB)
Field Operations Branch (DCNEBB2)
Facilities Support Branch (DCNEBB3)
ORA Inspection Branch (DCNEBB4)
CTP Inspection Branch (DCNEBB5)
Division of Grants, Agreements and Acquisitions Support (DCNEBC)
Grants and Assistance Agreements Branch (DCNEBC1)
Contracts Administration Branch (DCNEBC4)
Division of Information Technology Acquisitions (DCNEBD)
Information Technology Acquisitions Branch (DCNEBD1)
Systems Technology Acquisitions Branch (DCNEBD2)
IT Strategic Support Branch (DCNEBD3)
Division of Policy, Systems and Program Support (DCNEBE)
Acquisitions Policy and Oversight Branch (DCNEBE2)
Innovation Systems and Data Quality Branch (DCNEBE3)
Office of Financial Management (DCNEC)
Financial Systems Support Staff (DCNEC1)
User Fee Support Staff (DCNEC2)
Operations Support Staff (DCNEC3)
Controls, Compliance and Oversight Staff (DCNEC4)
Division of Accounting (DCNECA)
Division of Payment Services (DCNECC)
Division of Travel Services (DCNECD)
Office of Facilities, Engineering and Mission Support Services (DCNG)
[[Page 47571]]
Jefferson Laboratories Complex Staff (DCNG1)
Facilities Program Staff (DCNG2)
Division of Operations Management and Community Relations (DCNGA)
Logistics and Transportation Management Branch (DCNGA1)
Facilities Maintenance and Operations Branch (DCNGA2)
Auxiliary Program Management Staff (DCNGA3)
Division of Planning, Engineering and Space Management (DCNGB)
Portfolio and Space Management Branch (DCNGB1)
Engineering Management Branch (DCNGB2)
Office of Security and Passport Operations (DCNH)
Special Operations Staff (DCNH1)
Division of Resource Integration and Passport Operations (DCNHC)
Resource Integration Branch (DCNHC1)
Passport Operations Branch (DCNHC2)
Division of Personnel Security and Credentialing (DCNHD)
Personnel Vetting Branch (DCNHD1)
Identity and Credentialing Services Branch (DCNHD2)
Division of Physical Security and Integration (DCNHE)
Physical Security Branch (DCNHE1)
Security Integration Branch (DCNHE2)
Office of Human Capital Management (DCNI)
Office of Talent Solutions (DCNJ)
Office of FDA Commissioned Corps (DCNK)
DCP. ORGANIZATION. The Office of the Chief Scientist is headed by
the Chief Scientist and includes the following organization units:
Office of the Chief Scientist (DCP)
Advisory Committee Oversight and Management Staff (DCP1)
FDA Technology Transfer Program Staff (DCP2)
Administrative Management Staff (DCP3)
Informatics and Business Operations Staff (DCP4)
Office of Scientific Integrity (DCPD)
Office of Scientific Professional Development (DCPE)
National Center for Toxicological Research (DCPF)
Office of Occupational Safety and Health (DCPG)
Occupational Safety Staff (DCPG1)
Occupational Health Services Staff (DCPG2)
Office of Regulatory and Emerging Science (DCPH)
Regulatory Science Staff (DCPH1)
Preparedness Research Staff (DCPH2)
Communications and Outreach Staff (DCPH3)
Office of Cosmetics and Colors (DCPI)
Division of Color Certification and Technology (DCPIA)
Color Certification Branch (DCPIA1)
Color Technology Branch (DCPIA2)
Division of Cosmetics (DCPIB)
Cosmetics Regulatory Activities Branch (DCPIB1)
Cosmetics Regulatory Science Branch (DCPIB2)
Office of Analytical and Regulatory Laboratories (DCPJ)
Analytical and Regulatory Laboratories Staff (DCPJ1)
Detroit Medical Products Laboratory (DCPJA)
Irvine Medical Products Laboratory (DCPJB)
New York Medical Products Laboratory (DCPJC)
San Juan Medical Products Laboratory (DCPJD)
Tobacco Products Laboratory (DCPJE)
Office of Specialty Laboratories and Enforcement Support (DCPK)
National Forensic Chemistry Center (DCPKA)
Inorganic Branch (DCPKA1)
Organic Branch (DCPKA2)
Satellite Laboratory Branch (DCPKA3)
Winchester Engineering and Analytical Center (DCPKB)
Analytical Branch (DCPKB1)
Engineering Branch (DCPKB2)
Office of Science and Laboratory Advancement (DCPL)
Regulatory Operations Safety Staff (DCPL1)
DCR. ORGANIZATION. The Human Foods Program is headed by the Deputy
Commissioner for Human Foods, and includes the following organizational
units:
Human Foods Program (DCR)
Office of the Deputy Commissioner for Human Foods (DCRA)
Management Operations Staff (DCRA1)
Office of Executive Programs (DCRB)
Project and Portfolio Management Staff 1 (DCRB1)
Project and Portfolio Management Staff 2 (DCRB2)
Legislative and Program Issue Coordination and Executive Secretariat
Staff (DCRB3)
Office of Strategic Programing (DCRC)
Office of Policy and International Engagement (DCRD)
Office of Policy, Regulations, and Information (DCRDA)
Regulation and Policy Development Staff (DCRDA1)
Government Information Policy Staff (DCRDA2)
Office of Policy Initiatives and Projects (DCRDB)
Office of International Engagement (DCRDC)
Public Health and Trade Staff (DCRDC1)
Regulatory Cooperation and Partnerships Staff (DCRDC2)
Office of Resource Management (DCRE)
Division of Budget and Planning (DCREA)
Budget Formulation Branch (DCREA1)
Budget Execution Branch (DCREA2)
Acquisition Liaison Branch (DCREA3)
Financial Operations Branch (DCREA4)
Division of Workforce Management (DCREB)
Recruitment Liaison Branch (DCREB1)
Workforce Policy and Programs Branch (DCREB2)
Staff College (DCREB3)
Division of Information Technology Management (DCREC)
Regulatory and Data Management Branch (DCREC1)
Scientific Computing and IT Support Branch (DCREC2)
Division of Safety and Facilities Management (DCRED)
Division of Travel Management and Operations Support (DCREE)
Division of Management Support and Analysis (DCREF)
Office of Communications, Education, and Engagement (DCRF)
Internal Communications Staff (DCRF1)
Division of External Communications and Consumer Education (DCRFA)
Strategic Communications Branch (DCRFA1)
Consumer Education Branch (DCRFA2)
Division of Public Engagement and Information (DCRFB)
Public Engagement Branch (DCRFB1)
Public Information Branch (DCRFB2)
Division of Web, Visual, and Virtual Communications (DCRFC)
Web Branch (DCRFC1)
Graphics and Virtual Collaboration Branch (DCRFC2)
Office of Surveillance Strategy and Risk Prioritization (DCRG)
Advisory and Operations Staff (DCRG1)
Division of Surveillance and Data Integration (DCRGA)
Surveillance Design Branch (DCRGA1)
Signal Detection and Bioinformatics Branch (DCRGA2)
Surveillance Systems Operations Branch (DCRGA3)
Data Integration Branch (DCRGA4)
Division of Risk Assessment and Prioritization (DCRGB)
Hazard Characterization and Assessment Branch (DCRGB1)
Exposure Assessment Branch (DCRGB2)
Risk Assessment and Ranking Branch (DCRGB3)
Division of Evaluation and Population Health Science (DCRGC)
Behavioral and Social Sciences Branch (DCRGC1)
Epidemiology and Medical Sciences Branch (DCRGC2)
Signal Coordination and Triage Branch (DCRGC3)
[[Page 47572]]
Office of Coordinated Outbreak Response, Evaluation and Emergency
Preparedness (DCRH)
Division of Outbreak Data Management and Signals (DCRHA)
Division of Response (DCRHB)
Division of Preparedness and Emergency Programs (DCRHC)
Office of Compliance and Enforcement (DCRI)
Administrative Staff (DCRI1)
Compliance Initiatives Staff (DCRI2)
Office of Compliance Operations and Implementation (DCRIA)
Division of Compliance Operations (DCRIAA)
Compliance Operations Planning Branch (DCRIAA1)
Compliance Operations Analysis Branch (DCRIAA2)
Division of Compliance Implementation (DCRIAB)
Compliance Policy and Procedures Branch (DCRIAB1)
Compliance Programs and Assignments Branch (DCRIAB2)
Office of Enforcement (DCRIB)
Division of Critical Foods and Dietary Supplement Enforcement (DCRIBA)
Dietary Supplements Enforcement Branch (DCRIBA1)
Critical Foods and Labeling Enforcement Branch (DCRIBA2)
Division of Conventional Foods Enforcement (DCRIBB)
Conventional Foods Enforcement Branch 1(DCRIBB1)
Conventional Foods Enforcement Branch 2 (DCRIBB2)
Conventional Foods Enforcement Branch 3 (DCRIBB3)
Division of Produce and Imports Enforcement (DCRIBC)
Imports Enforcement Branch (DCRIBC1)
Produce Enforcement Branch (DCRIBC2)
Office of Compliance Intervention and Consultation (DCRIC)
Division of Recalls and Emerging Issues (DCRICA)
Recalls Branch (DCRICA1)
Emerging Issues Branch (DCRICA2)
Division of Compliance Consultation (DCRICB)
Compliance Consultation Branch 1 (DCRICB1)
Compliance Consultation Branch 2 (DCRICB2)
Office of Integrated Food Safety Systems Partnerships (DCRJ)
Partnerships Services Staff (DCRJ1)
Office of Domestic Partnerships (DCRJA)
Division of Domestic Partnership Coordination and Integration (DCRJAA)
Domestic Partnership Coordination and Integration Branch 1 (DCRJAA1)
Domestic Partnership Coordination and Integration Branch 2 (DCRJAA2)
Division of Domestic Partnership Investments (DCRJAB)
Human and Animal Branch (DCRJAB1)
Laboratory and Innovation Branch (DCRJAB2)
Produce Branch (DCRJAB3)
Office of Retailed Food Protection (DCRJB)
Division of Retail Food Protection Policy, Research, and Risk
Assessment (DCRJBA)
Retail Food Protection Branch 1 (DCRJBA1)
Retail Food Protection Branch 2 (DCRJBA2)
Division of Retail Food Protection Implementation (DCRJBB)
Retail Food Protection Implementation Branch 1 (DCRJBB1)
Retail Food Protection Implementation Branch 2 (DCRJBB2)
Retail Food Protection Implementation Branch 3 (DCRJBB3)
Office of Food Chemical Safety, Dietary Supplements, and Innovation
(DCRK)
Operations Staff (DCRK1)
Innovative Foods Staff (DCRK2)
Office of Pre-Market Additive Safety (DCRKA)
Division of Food Ingredients (DCRKAA)
Toxicology Review Branch (DCRKAA1)
Chemistry Evaluation Branch (DCRKAA2)
Regulatory Management Branch (DCRKAA3)
Division of Food Contact Substances (DCRKAB)
Toxicology Review Branch (DCRKAB1)
Chemistry Evaluation Branch (DCRKAB2)
Regulatory Management Branch (DCRKAB3)
Office of Post-Market Assessment (DCRKB)
Division of Chemical Contaminants (DCRKBA)
Division of Additives and Ingredients (DCRKBB)
Hazard Assessment and Analytics Branch (DCRKBB1)
Regulatory Management Branch (DCRKBB2)
Office of Dietary Supplement Programs (DCRKC)
Division of Policy and Regulatory Operations (DCRKCA)
Regulatory Operations Branch (DCRKCA1)
Policy and Communications Branch (DCRKCA2)
Division of Research and Evaluation (DCRKCB)
Identity and Status Branch (DCRKCB1)
Safety Evaluation Branch (DCRKCB2)
Nutrition Center of Excellence (DCRL)
Office of Nutrition and Food Labeling (DCRLA)
Division of Food Labeling and Standards (DCRLAA)
Labeling Regulations Implementation Branch (DCRLAA1)
Product Evaluation and Labeling Branch 1 (DCRLAA2)
Product Evaluation and Labeling Branch 2 (DCRLAA3)
Division of Nutrition Labeling, Science and Claims (DCRLAB)
Nutrition Assessment and Evaluation Branch (DCRLAB1)
Nutrition Science Review Branch (DCRLAB2)
Office of Critical Foods (DCRLB)
Infant Formula Pre-Market Review Staff (DCRLB1)
Office of Laboratory Operations and Applied Science (DCRM)
Office of Regulatory Testing and Surveillance (DCRMA)
Division of Science Program Coordination (DCRMAA)
Microbiology Branch (DCRMAA1)
Chemistry Branch (DCRMAA2)
Arkansas Human and Animal Food Laboratory (DCRMAB)
Arkansas Chemistry Branch (DCRMAB1)
Arkansas Microbiology Branch (DCRMAB2)
Atlanta Human and Animal Food Laboratory (DCRMAC)
Atlanta Chemistry Branch (DCRMAC1)
Atlanta Microbiology Branch (DCRMAC2)
Atlanta Nutrient Analysis Branch (DCRMAC3)
Denver Human and Animal Food Laboratory (DCRMAD)
Denver Chemistry Branch (DCRMAD1)
Denver Microbiology Branch (DCRMAD2)
Irvine Human and Animal Food Laboratory (DCRMAE)
Irvine Chemistry Branch (DCRMAE1)
Irvine Microbiology Branch (DCRMAE2)
Kansas City Human and Animal Food Laboratory (DCRMAF)
Kansas City Chemistry Branch 1 (DCRMAF1)
Kansas City Chemistry Branch 2 (DCRMAF2)
New York Human and Animal Food Laboratory (DCRMAG)
New York Chemistry Branch (DCRMAG1)
New York Microbiological Branch (DCRMAG2)
San Francisco Human and Animal Food Laboratory (DCRMAH)
San Francisco Chemistry Branch (DCRMAH1)
San Francisco Microbiology Branch (DCRMAH2)
Seattle Human and Animal Food Laboratory (DCRMAI)
Seattle Chemistry Branch (DCRMAI1)
Seattle Microbiology Branch (DCRMAI2)
Office of Applied Microbiology and Technology (DCRMB)
Division of Food and Environmental Safety (DCRMBA)
[[Page 47573]]
Environmental Microbiology Branch (DCRMBA1)
Virology and Parasitology Branch (DCRMBA2)
Microbial Methods Development Branch (DCRMBA3)
Division of Food Safety Genomics (DCRMBB)
Genomics Development and Application Branch (DCRMBB1)
Metagenomic Diversity and Ecology Branch (DCRMBB2)
Molecular Genetic Methods Branch (DCRMBB3)
Division of Food Processing Science and Technology (DCRMBC)
Chemistry and Process Engineering Branch (DCRMBC1)
Microbiology and Food Technology Branch (DCRMBC2)
Division of Seafood Science and Technology (DCRMBD)
Chemical Hazards Science Branch (DCRMBD1)
Microbiological Hazards Science Branch (DCRMBD2)
Office of Chemistry and Toxicology (DCRMC)
Division of Analytical Chemistry (DCRMCA)
Method Development Branch (DCRMCA1)
Spectroscopy and Mass Spectrometry Branch (DCRMCA2)
Division of Bioanalytical Chemistry (DCRMCB)
Bioanalytical Methods Branch (DCRMCB1)
Chemical Contaminants Branch (DCRMCB2)
Division of Toxicology (DCRMCC)
Predictive Toxicology Branch (DCRMCC1)
Systems Toxicology Branch (DCRMCC2)
Office of Scientific Coordination and Computational Sciences (DCRMD)
Senior Science Advisor Staff (DCRMD1)
Research Coordination Staff (DCRMD2)
GenomeTrakr and Computational Science Staff (DCRMD3)
Office of Quality Assessment and Management (DCRN)
Quality Assessment Staff (DCRN1)
Quality Management Staff (DCRN2)
Office of Microbiological Food Safety (DCRO)
Operations Staff (DCRO1)
Office of Dairy and Seafood Safety (DCROA)
Division of Dairy Safety (DCROAA)
Dairy Safety Policy Branch (DCROAA1)
Egg, Meat, and Laboratory Policy Branch (DCROAA2)
Dairy Operations East Branch (DCROAA3)
Dairy Operations West Branch (DCROAA4)
Division of Seafood Safety (DCROAB)
Shellfish and Aquaculture Policy Branch (DCROAB1)
Seafood Processing and Technology Policy Branch (DCROAB2)
Shellfish Operations Branch 1 (DCROAB3)
Shellfish Operations Branch 2 (DCROAB4)
Office of Produce Safety (DCROB)
Division of Fresh Produce Safety (DCROBA)
Fresh Produce Policy Branch (DCROBA1)
Produce Safety Engagement Branch (DCROBA2)
Division of Processed Food and Beverages Safety (DCROBB)
Processed Food and Beverages Policy Branch (DCROBB1)
Processed Produce Policy Branch (DCROBB2)
DCS. ORGANIZATION. The Office of Inspections and Investigations is
headed by the Associate Commissioner for Inspections and
Investigations, and includes the following organizational units:
Office of Inspections and Investigations (DCS)
Office of the Associate Commissioner for Inspections and Investigations
(DCSA)
Division of Organizational Communication and Engagement (DCSAA)
Strategic Communication Staff (DCSAA1)
Executive Secretariat Staff (DCSAA2)
Office of Management (DCSB)
Office of Budget, Facilities and Travel Support (DCSBA)
Division of Financial Operations (DCSBAA)
Human and Animal Food Budget Execution Branch (DCSBAA1)
Budget Formulation Branch (DCSBAA2)
Medical Products and Tobacco Budget Execution Branch (DCSBAA3)
Division of Facilities and Property Management (DCSBAB)
Real Property Branch 1 (DCSBAB1)
Real Property Branch 2 (DCSBAB2)
Real Property Branch 3 (DCSBAB3)
Fleet and Personal Property Management Branch (DCSBAB4)
Real Property Branch 4 (DCSBAB5)
Real Property Branch 5 (DCSBAB6)
Real Property Branch 6 (DCSBAB7)
Division of Contracts and Grants (DCSBAC)
Operational Contracts and Agreements Branch 1 (DCSBAC1)
Operational Contracts and Agreements Branch 2 (DCSBAC2)
Division of Travel Operations (DCSBAD)
Domestic Travel Branch (DCSBAD1)
Foreign Travel Branch 1 (DCSBAD2)
Foreign Travel Branch 2 (DCSBAD3)
Foreign Travel Branch 3 (DCSBAD4)
Foreign Travel Branch 4 (DCSBAD5)
Office of Workforce Management (DCSBB)
Executive and Scientific Resource Staff (DCSBB1)
Division of Human Capital Staffing Services (DCSBBA)
Talent Acquisition Branch 1 (DCSBBA1)
Talent Acquisition Branch 2 (DCSBBA2)
Talent Acquisition Branch 3 (DCSBBA3)
Division of Human Capital Programs (DCSBBB)
Performance Management and Engagement Branch (DCSBBB1)
Management Analysis Branch (DCSBBB2)
Office of Animal Food Inspectorate (DCSC)
Division of Animal Food Inspectorate I (DCSCA)
Animal Food Investigations Branch 1 (DCSCA1)
Animal Food Investigations Branch 2 (DCSCA2)
Animal Food Investigations Branch 3 (DCSCA3)
Division of Animal Food Inspectorate II (DCSCB)
Animal Food Investigations Branch 1 (DCSCB1)
Animal Food Investigations Branch 2 (DCSCB2)
Animal Food Investigations Branch 3 (DCSCB3)
Office of Biologics Inspectorate (DCSD)
Biologics Global Operations Staff (DCSD1)
Division of Biologics Inspectorate I (DCSDB)
Biologics Investigations Branch 1 (DCSDB1)
Biologics Investigations Branch 2 (DCSDB2)
Biologics Investigations Branch 3 (DCSDB3)
Biologics Investigations Branch 4 (DCSDB4)
Division of Biologics Inspectorate II (DCSDC)
Biologics Investigations Branch 1 (DCSDC1)
Biologics Investigations Branch 2 (DCSDC2)
Biologics Investigations Branch 3 (DCSDC3)
Division of Biologics Inspectorate III (DCSDD)
Biologics Investigations Branch 1 (DCSDD1)
Biologics Investigations Branch 2 (DCSDD2)
Biologics Investigations Branch 3 (DCSDD3)
Division of Biotechnology Inspectorate (DCSDE)
Biotechnology Investigations Branch 1 (DCSDE1)
Biotechnology Investigations Branch 2 (DCSDE2)
[[Page 47574]]
Office of Bioresearch Monitoring Inspectorate (DCSE)
Division of Bioresearch Monitoring Global Operations (DCSEA)
Bioresearch Monitoring Foreign Investigations Branch 1 (DCSEA1)
Bioresearch Monitoring Foreign Investigations Branch 2 (DCSEA2)
Bioresearch Monitoring Inspectorate Expert Support Branch (DCSEA3)
Division of Bioresearch Monitoring Inspectorate I (DCSEB)
Bioresearch Monitoring Investigations Branch 1 (DCSEB1)
Bioresearch Monitoring Investigations Branch 2 (DCSEB2)
Bioresearch Monitoring Investigations Branch 3 (DCSEB3)
Bioresearch Monitoring Investigations Branch 4 (DCSEB4)
Division of Bioresearch Monitoring Inspectorate II (DCSEC)
Bioresearch Monitoring Investigations Branch 1 (DCSEC1)
Bioresearch Monitoring Investigations Branch 2 (DCSEC2)
Bioresearch Monitoring Investigations Branch 3 (DCSEC3)
Division of Bioresearch Monitoring Inspectorate III (DCSED)
Bioresearch Monitoring Investigations Branch 1 (DCSED1)
Bioresearch Monitoring Investigations Branch 2 (DCSED2)
Bioresearch Monitoring Investigations Branch 3 (DCSED3)
Division of Bioresearch Monitoring Inspectorate IV (DCSEF)
Bioresearch Monitoring Investigations Branch 1 (DCSEF1)
Bioresearch Monitoring Investigations Branch 2 (DCSEF2)
Bioresearch Monitoring Investigations Branch 3 (DCSEF3)
Office of Business Informatics and Solutions Management (DCSF)
Division of Import Business Informatics and Solutions (DCSFB)
Import Business Informatics Branch (DCSFB1)
Import Business Solutions Branch (DCSFB2)
Division of Regulatory Business Informatics and Solutions (DCSFC)
Regulatory Business Informatics Branch (DCSFC1)
Regulatory Business Solutions Branch (DCSFC2)
Division of Solutions Planning, Management and Governance (DCSFD)
Integrated Management and Investments Branch (DCSFD1)
Program Solutions and Services Branch (DCSFD2)
Division of Work Planning and Analytics (DCSFE)
Work Planning and Analytics Branch (DCSFE1)
Informatics and Process Quality Branch (DCSFE2)
Office of Criminal Investigations (DCSG)
Metro Washington Field Office (DCSGA)
Philadelphia Resident Unit (DCSGA1)
Chicago Field Office (DCSGB)
New York Field Office (DCSGC)
Boston, MA Resident Unit (DCSGC1)
Los Angeles Field Office (DCSGD)
San Francisco, CA Resident Unit (DCSGD1)
Miami Field Office (DCSGE)
San Juan, PR Resident Unit (DCSGE1)
Atlanta, GA Resident Unit (DCSGE2)
New Orleans, LA Resident Unit (DCSGE3)
Kansas City Field Office (DCSGF)
Dallas, TX Resident Unit (DCSGF1)
Office of Field Operations and Response (DCSH)
Organizational Quality Staff (DCSH1)
Office of Field Regulatory Operations (DCSHA)
Division of Field Enforcement (DCSHAA)
Health Fraud Inspectorate Branch (DCSHAA1)
Field Recall Effectiveness Branch (DCSHAA2)
Division of Inspectorate Policy (DCSHAB)
Food Inspectorate Policy Branch (DCSHAB1)
Medical Products and Tobacco Inspectorate Policy Branch (DCSHAB2)
Division of Tobacco Inspectorate (DCSHAC)
Tobacco Investigations Branch 1 (DCSHAC1)
Tobacco Investigations Branch 2 (DCSHAC2)
Office of Emergency Response (DCSHB)
Division of Emergency Response (DCSHBA)
Field Emergency Response Coordinators Branch 1 (DCSHBA1)
Field Emergency Response Coordinators Branch 2 (DCSHBA2)
Incident Coordination Branch (DCSHBA3)
Division of Emergency Preparedness and Support (DCSHBB)
Emergency Planning, Exercises and Evaluation Branch (DCSHBB2)
Program Operations and Coordination Branch (DCSHBB3)
Office of Training, Education, and Development (DCSI)
Division of Programmatic Training (DCSIA)
Programmatic Training Branch 1 (DCSIA1)
Programmatic Training Branch 2 (DCSIA2)
Division of Multi-Program, Leadership, and Management Training (DCSIB)
Multi-Program, Leadership, and Management Branch (DCSIB1)
Leadership, Management, and Mentoring Training Branch (DCSIB2)
Division of Instructional Systems and Technology (DCSIC)
Instructional Systems Branch (DCSIC1)
Learning Management Technology and Multimedia Branch (DCSIC2)
Certification Branch (DCSIC3)
Office of Human and Animal Drug Inspectorate (DCSJ)
Division of Human and Animal Drug Foreign Inspectorate (DCSJA)
Human and Animal Drug Foreign Investigations Branch 1 (DCSJA1)
Human and Animal Drug Foreign Investigations Branch 2 (DCSJA2)
Human and Animal Drug Foreign Operations Branch (DCSJA3)
Division of Human and Animal Drug Global Operations (DCSJB)
Human and Animal Drug Program Operations Branch (DCSJB1)
Human and Animal Drug Mutual Recognition Branch (DCSJB2)
Division of Human and Animal Drug Inspectorate I (DCSJC)
Human and Animal Drug Investigations Branch 1 (DCSJC1)
Human and Animal Drug Investigations Branch 2 (DCSJC2)
Human and Animal Drug Investigations Branch 3 (DCSJC3)
Human and Animal Drug Investigations Branch 4 (DCSJC4)
Human and Animal Drug Investigations Branch 5 (DCSJC5)
Division of Human and Animal Drug Inspectorate II (DCSJD)
Human and Animal Drug Investigations Branch 1 (DCSJD1)
Human and Animal Drug Investigations Branch 2 (DCSJD2)
Human and Animal Drug Investigations Branch 3 (DCSJD3)
Human and Animal Drug Investigations Branch 4 (DCSJD4)
Human and Animal Drug Investigations Branch 5 (DCSJD5)
Division of Human and Animal Drug Inspectorate III (DCSJE)
Human and Animal Drug Investigations Branch 1 (DCSJE1)
Human and Animal Drug Investigations Branch 2 (DCSJE2)
Human and Animal Drug Investigations Branch 3 (DCSJE3)
Human and Animal Drug Investigations Branch 4 (DCSJE4)
Human and Animal Drug Investigations Branch 5 (DCSJE5)
Division of Human and Animal Drug Inspectorate IV (DCSJF)
Human and Animal Drug Investigations Branch 1 (DCSJF1)
Human and Animal Drug Investigations Branch 2 (DCSJF2)
Human and Animal Drug Investigations Branch 3 (DCSJF3)
Human and Animal Drug Investigations Branch 4 (DCSJF4)
[[Page 47575]]
Human and Animal Drug Investigations Branch 5 (DCSJF5)
Division of Human and Animal Drug Inspectorate V (DCSJG)
Human and Animal Drug Investigations Branch 1 (DCSJG1)
Human and Animal Drug Investigations Branch 2 (DCSJG2)
Human and Animal Drug Investigations Branch 3 (DCSJG3)
Human and Animal Drug Investigations Branch 4 (DCSJG4)
Human and Animal Drug Investigations Branch 5 (DCSJG5)
Division of Human and Animal Drug Inspectorate VI (DCSJH)
Human and Animal Drug Investigations Branch 1 (DCSJH1)
Human and Animal Drug Investigations Branch 2 (DCSJH2)
Human and Animal Drug Investigations Branch 3 (DCSJH3)
Human and Animal Drug Investigations Branch 4 (DCSJH4)
Human and Animal Drug Investigations Branch 5 (DCSJH5)
Office of Human Food Inspectorate (DCSK)
Office of Human Food Inspectorate Central (DCSKA)
Division of Human Food Inspectorate Central I (DCSKAA)
Human Food Investigations Branch 1 (DCSKAA1)
Human Food Investigations Branch 2 (DCSKAA2)
Human Food Investigations Branch 3 (DCSKAA3)
Human Food Investigations Branch 4 (DCSKAA4)
Division of Human Food Inspectorate Central II (DCSKAB)
Human Food Investigations Branch 1 (DCSKAB1)
Human Food Investigations Branch 2 (DCSKAB2)
Human Food Investigations Branch 3 (DCSKAB3)
Human Food Investigations Branch 4 (DCSKAB4)
Human Food Investigations Branch 5 (DCSKAB5)
Division of Human Food Inspectorate Central III (DCSKAC)
Human Food Investigations Branch 1 (DCSKAC1)
Human Food Investigations Branch 2 (DCSKAC2)
Human Food Investigations Branch 3 (DCSKAC3)
Human Food Investigations Branch 4 (DCSKAC4)
Human Food Investigations Branch 5 (DCSKAC5)
Human Food Investigations Branch 6 (DCSKAC6)
Division of Human Food Inspectorate Central IV (DCSKAD)
Human Food Investigations Branch 1 (DCSKAD1)
Human Food Investigations Branch 2 (DCSKAD2)
Human Food Investigations Branch 3 (DCSKAD3)
Human Food Investigations Branch 4 (DCSKAD4)
Division of Human Food Inspectorate Central V (DCSKAE)
Human Food Investigations Branch 1 (DCSKAE1)
Human Food Investigations Branch 2 (DCSKAE2)
Human Food Investigations Branch 3 (DCSKAE3)
Human Food Investigations Branch 4 (DCSKAE4)
Human Food Investigations Branch 5 (DCSKAE5)
Office of Human Food Inspectorate East (DCSKB)
Division of Human Food Inspectorate East I (DCSKBA)
Human Food Investigations Branch 1 (DCSKBA1)
Human Food Investigations Branch 2 (DCSKBA2)
Human Food Investigations Branch 3 (DCSKBA3)
Human Food Investigations Branch 4 (DCSKBA4)
Human Food Investigations Branch 5 (DCSKBA5)
Division of Human Food Inspectorate East II (DCSKBB)
Human Food Investigations Branch 1 (DCSKBB1)
Human Food Investigations Branch 2 (DCSKBB2)
Human Food Investigations Branch 3 (DCSKBB3)
Human Food Investigations Branch 4 (DCSKBB4)
Division of Human Food Inspectorate East III (DCSKBC)
Human Food Investigations Branch 1 (DCSKBC1)
Human Food Investigations Branch 2 (DCSKBC2)
Human Food Investigations Branch 3 (DCSKBC3)
Human Food Investigations Branch 4 (DCSKBC4)
Division of Human Food Inspectorate East IV (DCSKBD)
Human Food Investigations Branch 1 (DCSKBD1)
Human Food Investigations Branch 2 (DCSKBD2)
Human Food Investigations Branch 3 (DCSKBD3)
Human Food Investigations Branch 4 (DCSKBD4)
Human Food Investigations Branch 5 (DCSKBD5)
Human Food Investigations Branch 6 (DCSKBD6)
Office of Human Food Inspectorate West (DCSKC)
Division of Human Food Inspectorate West I (DCSKCA)
Human Food Investigations Branch 1 (DCSKCA1)
Human Food Investigations Branch 2 (DCSKCA2)
Human Food Investigations Branch 3 (DCSKCA3)
Human Food Investigations Branch 4 (DCSKCA4)
Human Food Investigations Branch 5 (DCSKCA5)
Division of Human Food Inspectorate West II (DCSKCB)
Human Food Investigations Branch 1 (DCSKCB1)
Human Food Investigations Branch 2 (DCSKCB2)
Human Food Investigations Branch 3 (DCSKCB3)
Human Food Investigations Branch 4 (DCSKCB4)
Human Food Investigations Branch 5 (DCSKCB5)
Division of Human Food Inspectorate West III (DCSKCC)
Human Food Investigations Branch 1 (DCSKCC1)
Human Food Investigations Branch 2 (DCSKCC2)
Human Food Investigations Branch 3 (DCSKCC3)
Human Food Investigations Branch 4 (DCSKCC4)
Division of Human Food Inspectorate West IV (DCSKCD)
Human Food Investigations Branch 1 (DCSKCD1)
Human Food Investigations Branch 2 (DCSKCD2)
Human Food Investigations Branch 3 (DCSKCD3)
Human Food Investigations Branch 4 (DCSKCD4)
Office of Global and Specialty Human Food Inspectorate (DCSKD)
Human Food National Expert Staff (DCSKD1)
Division of Critical and Specialty Food (DCSKDA)
Critical Food Investigations Branch (DCSKDA1)
Food Defense Branch (DCSKDA2)
Human Food Program Expert Branch (DCSKDA3)
Emerging Food and Specialty Products Branch (DCSKDA4)
Division of Foreign Food Investigations and Global Operations (DCSKDB)
Foreign Food Investigations Branch 1 (DCSKDB1)
Foreign Food Investigations Branch 2 (DCSKDB2)
Foreign Food Investigations Branch 3 (DCSKDB3)
Foreign Food Operations Branch (DCSKDB4)
Foreign Food Coordination Branch (DCSKDB5)
Division of Produce Safety (DCSKDC)
Produce Safety Branch 1 (DCSKDC1)
[[Page 47576]]
Produce Safety Branch 2 (DCSKDC2)
Produce Safety Branch 3 (DCSKDC3)
Office of Import Operations (DCSL)
Division of Targeting and Analysis (DCSLA)
Division of Import Operations (DCSLB)
Import Operations Branch (DCSLB1)
Import Compliance Branch (DCSLB2)
Division of Analysis and Program Evaluation (DCSLC)
Program Development Branch (DCSLC1)
Import Technical Assistance Branch (DCSLC2)
Division of Southwest Imports (DCSLD)
Southwest Import Investigations Branch (DCSLD1)
Southwest Import Compliance Branch (DCSLD2)
Division of Southeast Imports (DCSLE)
Southeast Import Investigations Branch 1 (DCSLE1)
Southeast Import Investigations Branch 2 (DCSLE2)
Southeast Import Compliance Branch (DCSLE3)
Division of Northeast Imports (DCSLF)
Northeast Import Investigations Branch (DCSLF1)
Northeast Import Compliance Branch (DCSLF2)
Division of Northern Border Imports (DCSLG)
Northern Border Import Investigations Branch 1 (DCSLG1)
Northern Border Import Investigations Branch 2 (DCSLG2)
Northern Border Import Compliance Branch (DCSLG3)
Division of West Coast Imports (DCSLH)
West Coast Import Investigations Branch (DCSLH1)
West Coast Import Compliance Branch (DCSLH2)
Division of Planning and Public Response (DCSLI)
Office of Medical Device and Radiological Health Inspectorate (DCSM)
Division of Mammography and Radiological Health Inspectorate (DCSMA)
Mammography Operations Branch 1 (DCSMA1)
Mammography Operations Branch 2 (DCSMA2)
Division of Medical Device and Radiological Health Inspectorate I
(DCSMB)
Medical Device and Radiological Health Investigations Branch 1 (DCSMB1)
Medical Device and Radiological Health Investigations Branch 2 (DCSMB2)
Medical Device and Radiological Health Investigations Branch 3 (DCSMB3)
Medical Device and Radiological Health Investigations Branch 4 (DCSMB4)
Division of Medical Device and Radiological Health Inspectorate II
(DCSMC)
Medical Device and Radiological Health Investigations Branch 1 (DCSMC1)
Medical Device and Radiological Health Investigations Branch 2 (DCSMC2)
Medical Device and Radiological Health Investigations Branch 3 (DCSMC3)
Medical Device and Radiological Health Investigations Branch 4 (DCSMC4)
Medical Device and Radiological Health Investigations Branch 5 (DCSMC5)
Division of Medical Device and Radiological Health Inspectorate III
(DCSMD)
Medical Device and Radiological Health Investigations Branch 1 (DCSMD1)
Medical Device and Radiological Health Investigations Branch 2 (DCSMD2)
Medical Device and Radiological Health Investigations Branch 3 (DCSMD3)
Medical Device and Radiological Health Investigations Branch 4 (DCSMD4)
Medical Device and Radiological Health Investigations Branch 5 (DCSMD5)
Division of Medical Device and Radiological Health Global Operations
(DCSME)
Medical Device and Radiological Health Foreign Operations Branch
(DCSME1)
Medical Device and Radiological Health Operations Branch (DCSME2)
Medical Device and Radiological Health Risk Mitigation and Response
Branch (DCSME3)
Division of Medical Device and Radiological Health Inspectorate IV
(DCSMF)
Medical Device and Radiological Health Investigations Branch 1 (DCSMF1)
Medical Device and Radiological Health Investigations Branch 2 (DCSMF2)
Medical Device and Radiological Health Investigations Branch 3 (DCSMF3)
Medical Device and Radiological Health Investigations Branch 4 (DCSMF4)
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.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2024-11893 Filed 5-30-24; 11:15 am]
BILLING CODE 4164-01-P
