Statement of Organization, Functions, and Delegations of Authority

Cited as:84 FR 22854
Court:Food And Drug Administration
Publication Date:20 May 2019
Record Number:2019-10431
Federal Register, Volume 84 Issue 97 (Monday, May 20, 2019)
[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
                [Notices]
                [Pages 22854-22858]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-10431]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                Statement of Organization, Functions, and Delegations of
                Authority
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice.
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                SUMMARY: The Food and Drug Administration (FDA), Office of the
                Commissioner, Headquarters organizations, and Centers have modified
                their structures.
                FOR FURTHER INFORMATION CONTACT: William Tootle, Director, Office of
                Budget, Office of the Commissioner, Food and Drug Administration, 4041
                Powder Mill Rd., Rm. 72094, Beltsville, MD 20705-4304, 301-796-4710.
                SUPPLEMENTARY INFORMATION:
                I. Introduction
                 Part D, Chapter D-B, (Food and Drug Administration), the Statement
                of Organization, Functions, and Delegations of Authority for the
                Department of Health and Human Services (35 FR 3685, February 25, 1970;
                60 FR 56606, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112,
                August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July
                28, 2011) is amended to reflect the reorganization of the Office of the
                Commissioner/FDA Headquarters and the following Centers: Center for
                Devices and Radiological Health (CDRH), Center for Drug Evaluation and
                Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN),
                Center for Tobacco Products (CTP), and Center for Veterinary Medicine
                (CVM).
                 The Office of the Commissioner reorganization will transition FDA
                away from the Directorate structure. Abolishing the current directorate
                structure and realigning many of those functions to the Centers/Office
                of Regulatory Affairs (ORA) establishes a direct line of communication
                between the Centers/ORA and the Commissioner of Food and Drugs. This
                direct report relationship with the Centers streamlines communications
                and better positions FDA to support its regulatory programs and
                mission. The intent is to create a more effective structure that better
                reflects FDA's priorities and streamlines operations.
                 The CDRH reorganization will more accurately reflect the functions
                performed by the Center and help to enhance CDRH's ability to advance
                FDA's mission and streamline operations and support functions.
                 The CDER reorganization changes the organizational structures and
                revises the functional statements of following organizations: Office of
                Communication (OCOMM), Office of Compliance (OC), Office of Executive
                Programs (OEP), Office of Hematology and Oncology Products (OHOP), and
                Office of New Drugs (OND). The proposed organizational changes will
                enhance CDER's ability to develop, coordinate, and evaluate public
                health communication and education activities in support of the
                following:
                 The CDER Office of Compliance proposed structure change will
                establish the framework for a stronger regulatory oversight of the
                compounded human drugs facilities and compounding related activities.
                The new structure will help ensure the following: That compounding
                pharmacies operate within the bounds of traditional pharmacy practice
                (not manufacturing); that outsourcing facilities operate according to
                the conditions in section 503B; and the new structure will protect
                patients from unsafe or ineffective compounded drugs.
                 The CDER Office of Communication is planning to expand CDER's
                communications outreach and educational efforts to inform the
                conversation among FDA's stakeholders. This will be managed through
                accessing more communication channels, enhancing FDA's social media
                presence, and using more innovative tools. The impact of CDER's growth
                has impacted the volume of information posted on the web as the content
                management and development of tools used to connect stakeholders with
                web content are created. As new programs and initiatives are developed
                by the Center, the web content will increase. The new content
                management system will provide the Agency with the opportunity to
                finally have a true publishing tool. This will allow greater speed in
                posting the content in the web environment.
                 The CDER Office of Executive Programs houses all the executive
                functions for CDER and ensures the goals and priorities of the Center
                Director are carried out. These functions range from administrative
                support for the Center Director's Office, overseeing the Center's
                learning and organizational development program, to managing the
                Center's 18 different Advisory Committees. Restructuring these
                functions into defined organizational structures will improve decision
                making by promoting the direct flow of information from frontline
                employees to the managers directly responsible for making decisions and
                provide clarity to staff roles and responsibilities. Furthermore, the
                proposed organizational changes permit Office of Executive Programs'
                managers to better define critical business processes and identify
                opportunities for streamlining complex tasks, which will facilitate a
                more efficient and strategic deployment of these resources during
                public health emergencies and outbreaks. The proposed changes align
                with Reimagine HHS guiding principle #3--Generating Efficiencies
                through Streamlined Processes and Reimagine HHS guiding principle #5--
                HHS as a More Innovative and Responsive Organization.
                 The CDER Office of Hematology and Oncology Products reorganization
                is in response to Title III of the 21st Century Cures Act (Cures Act),
                enacted into law on December 13, 2016, which provides authorities FDA
                can use to help modernize drug, biological, and device product
                development and review to create greater efficiencies and
                predictability in product development and review. Numerous initiatives
                are currently taking place in the Agency to carry out the plan laid out
                in the Cures Act and include: Patient Focused Drug Development; Novel
                Clinical Trial Design; Real World Evidence; Summary-level Review and
                Inter-Center Institutes; as well as other initiatives. The Office of
                Hematology and Oncology Products
                [[Page 22855]]
                has been an active participant and at times a leader in many of these
                initiatives. To meet external and internal stakeholders' expectations
                and to effectively and efficiently carry out these initiatives
                delineated in the Cures Act, it is necessary to flatten out the
                organizational structure. The office proposes to expand their clinical
                review divisions from three to five, create a centralized safety
                reporting team, and create a labeling team. The office is dedicated in
                modernizing the drug, biological, and device product development and
                review and in creating greater efficiencies and predictability in
                oncology product development and review. With this restructuring, the
                office, working in partnership with the Oncology Center of Excellence,
                can ensure that the Agency's initiatives are being worked on in an
                efficient and cohesive manner so that industry and all other outside
                groups feel as if we are working with them in the fight against cancer.
                 The CDER Office of Therapeutic Biologics and Biosimilars
                reorganization is in response to the Biologics Price Competition and
                Innovation Act of 2009 (BPCI Act), which was enacted on March 23, 2010.
                This law amended the Public Health Service Act (PHS Act) to create an
                abbreviated licensure pathway for biological products that are
                demonstrated to be biosimilar to or interchangeable with an already
                approved FDA-licensed biological product (the reference product). This
                pathway was established to provide more treatment options, increase
                access to lifesaving medications, and potentially reduce healthcare
                costs through increased competition. The current review management and
                policy development approach for biosimilar and interchangeable products
                lacks a ``primary owner'' and this impacts CDER's ability to set a
                singular goal and focus on internal operational requirements and
                communication similar to new drugs and generic drugs products.
                Specifically, policy development is fractured between the CDER Office
                of Medical Policy (OMP), Office of New Drugs (OND), and Office of
                Regulatory Policy (ORP). Since there is no office that holds primary
                responsibility for setting policy direction, the drafting and
                responding to inquiries such as citizen petitions and the development
                of policy positions is split between the various organizations.
                Likewise, the communication efforts are split between CDER OMP, OND,
                and OCOMM. While there is clear evidence of operational efficiencies
                associated with the review process for biosimilar and interchangeable
                products, the biggest inefficiency is with policy development. This
                proposed reorganization will be part of FDA's ongoing efforts to
                achieve the performance goals agreed to by the Agency in conjunction
                with the reauthorization of Biosimilar User Fee Act (BsUFA II).
                 The CFSAN reorganization realigns functions and personnel,
                retitling and establishing of new organizations within the CFSAN
                offices of: Office of Cosmetics and Colors, Office of Food Additive
                Safety, and Office of Coordinated Outbreak Response and Evaluation
                Network, which formalize its organizational components and functions;
                distinguish operational culture between pre- and post-market review;
                clarify staff allocation; improve effectiveness; and increase
                efficiency in the management and leadership for internal and external
                stakeholders.
                 The CTP Office of Health Communication and Education reorganization
                establishes the Division of Research and Evaluation; changes the title
                of the Division of Health, Scientific, and Regulatory Communication to
                the Division of Regulatory Communication; and revises the functional
                statements of the Office of Health Communication and Education; the
                Division of Public Health Education; and the Division of Regulatory
                Communication. The proposed organizational changes will enhance the
                Center's ability to develop, coordinate, and evaluate public health
                communication and education activities in support of requirements of
                the Family Smoking Prevention and Tobacco Control Act.
                 The CVM reorganization affects the Center's Office of Management
                and Office of New Animal Drug Evaluation.
                 The CVM Office of Management reorganization establishes the
                Business Informatics Staff; abolishes the Management Logistics Staff;
                and revises the functional statements of the Office of Management. The
                organizational changes will enhance CVM's ability to promote
                information technology guidelines and policies; manage the center's
                information technology portfolio; and provide capital planning and
                investment controls to the Department of Health and Human Services.
                 The CVM Office of New Animal Drug Evaluation reorganization
                establishes the Division of Animal Bioengineering and Cellular
                Therapies and revises the functional statements of the Office of New
                Animal Drug Evaluation. The organizational changes will create a
                dedicated group for the review and approval of biologically derived
                emerging technologies, such as animal bioengineering and cell and gene
                therapy products.
                 The Food and Drug Administration, Office of the Commissioner (OC)
                and Headquarters, Centers, and Offices, have been restructured as
                follows:
                 DCA. ORGANIZATION. The Office of the Commissioner is headed by
                the Commissioner of Food and Drugs, and includes the following
                organizational units:
                OFFICE OF THE COMMISSIONER
                Office of the Chief Counsel
                Office of the Executive Secretariat
                Freedom of Information Staff
                Office of the Counselor to the Commissioner
                 DCB. ORGANIZATION. The Center for Biologics Evaluation and
                Research is headed by the Center Director.
                CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
                 DCC. ORGANIZATION. The Center for Devices and Radiological
                Health is headed by the Center Director and includes the following
                organizational units:
                CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
                Office of the Center Director
                Quality Management Staff
                Office of Science and Engineering Laboratories
                Management Support Staff
                Division of Biomedical Physics
                Division of Imaging, Diagnostics, and Software Reliability
                Division of Applied Mechanics
                Division of Administrative and Laboratory Support
                Division of Biology, Chemistry and Materials Science
                Office of Communication and Education
                Program Management Operations Staff
                Division of Communication
                Web and Graphics Branch
                External Communications Branch
                Internal Communications Branch
                Division of Industry and Consumer Education
                Postmarket and Consumer Branch
                Premarket Programs Branch
                Division of Information Disclosure
                Freedom of Information Branch A
                Freedom of Information Branch B
                Division of Employee Training and Development
                Employee Development Branch
                Technology and Learning Management Branch
                Office of Management
                Planning and Program Analysis Staff
                Division of Workforce Management
                Division of Financial Management
                Division of Management Services
                Division of Acquisition Services
                Office of Product Evaluation and Quality
                Quality and Analytics Staff
                Clinical and Scientific Policy Staff
                Strategic Initiatives Staff
                Regulation, Policy and Guidance Staff
                Office of Regulatory Programs
                Division of Regulatory Programs I
                Division of Regulatory Programs II
                Division of Regulatory Programs III
                Office of Clinical Evidence and Analysis
                [[Page 22856]]
                Division of Clinical Evidence and Analysis I
                Division of Clinical Evidence and Analysis II
                Office of Health Technology I
                Division of Health Technology I A
                Division of Health Technology I B
                Division of Health Technology I C
                Office of Health Technology II
                Division of Health Technology II A
                Division of Health Technology II B
                Division of Health Technology II C
                Office of Health Technology III
                Division of Health Technology III A
                Division of Health Technology III B
                Division of Health Technology III C
                Office of Health Technology IV
                Division of Health Technology IV A
                Division of Health Technology IV B
                Office of Health Technology V
                Division of Health Technology V A
                Division of Health Technology V B
                Office of Health Technology VI
                Division of Health Technology VI A
                Division of Health Technology VI B
                Division of Health Technology VI C
                Office of In Vitro Diagnostics and Radiological Health
                Division of Chemistry and Toxicology Devices
                Chemistry Branch
                Diabetes Branch
                Toxicology Branch
                Cardio-Renal Diagnostics Branch
                Division of Immunology and Hematology Devices
                Hematology Branch
                Immunology and Flow Cytometry Branch
                Division of Microbiology Devices
                Viral Respiratory and Human Papilloma Respiratory Branch
                General Viral and Hepatitis Branch
                General Bacterial and Antimicrobial Susceptibility Branch
                Bacterial Respiratory and Medical Countermeasures Branch
                Division of Radiological Health
                Magnetic Resonance and Electronic Products Branch
                Diagnostic X-Ray Systems Branch
                Nuclear Medicine and Radiation Therapy Branch
                Mammography, Ultrasound and Imaging Software Branch
                Division of Mammography Quality Standards
                Program Management Branch
                Information Management Branch
                Division of Program Operations and Management
                Division of Molecular Genetics and Pathology
                Molecular Pathology and Cytology Branch
                Molecular Genetics Branch
                Office of Strategic Partnerships and Technology Innovation
                Division of All Hazards Response, Science and Strategic Partnerships
                Division of Digital Health
                Division of Technology and Data Services
                Office of Policy
                 DCD. ORGANIZATION. The Center for Drug Evaluation and Research
                is headed by the Director and includes the following organization
                units:
                CENTER FOR DRUG EVALUATION AND RESEARCH
                Office of the Center Director
                Office of Regulatory Policy
                Office of Management
                Office of Communications
                Office of Compliance
                Office of Manufacturing Quality
                Office of Unapproved Drugs and Labeling Compliance
                Office of Scientific Investigations
                Office of Program and Regulatory Operations
                Office of Medical Policy
                Office of Prescription Drug Promotion
                Office of Medical Policy Initiatives
                Office of Translational Sciences
                Office of Biostatistics
                Office of Clinical Pharmacology
                Office of Computational Science
                Office of Study Integrity and Surveillance
                Office of Executive Programs
                Office of Surveillance and Epidemiology
                Office of Medication Error Prevention and Risk Management
                Office of Pharmacovigilance and Epidemiology
                Office of New Drugs
                Office of Drug Evaluation I
                Office of Drug Evaluation II
                Office of Drug Evaluation III
                Office of Antimicrobial Products
                Office of Drug Evaluation IV
                Office of Hematology and Oncology Products
                Office of Strategic Programs
                Office of Program and Strategic Analysis
                Office of Business Informatics
                Office of Generic Drugs
                Office of Research Standards
                Office of Bioequivalence
                Office of Generic Drug Policy
                Office of Regulatory Operations
                Office of Pharmaceutical Quality
                Office of Biotechnology Products
                Office of New Drug Products
                Office of Policy for Pharmaceutical Quality
                Office of Process and Facilities
                Office of Surveillance
                Office of Testing and Research
                Office of Program and Regulatory Operations
                Office of Lifecycle Drug Products
                 DCE. ORGANIZATION. The Center for Food Safety and Applied
                Nutrition is headed by the Center Director.
                CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
                 DCED. ORGANIZATION. The Office of Food Additive Safety is headed
                by the Director, Office of Food Additive Safety, and includes the
                following organizational units:
                Office of Food Additive Safety
                Operations Staff
                Division of Food Contact Substances
                Toxicology Review Branch
                Chemistry Review Branch
                Regulatory Review Branch
                Division of Food Ingredients
                Toxicology Review Branch
                Chemistry Review Branch
                Regulatory Review Branch
                Division of Biotechnology, Regulatory Science, and Surveillance
                Post-Market Review Branch
                Scientific Support Branch
                 DCEE. ORGANIZATION. The Office of Cosmetics and Colors is headed
                by the Director, Office of Cosmetics and Colors, and includes the
                following organizational units:
                Office of Cosmetics and Colors
                Division of Cosmetics and Colors
                Color Certification Branch
                Color Technology Branch
                Division of Cosmetics
                Cosmetics Regulatory Activities Branch
                Cosmetics Regulatory Science Branch
                 DCEN. ORGANIZATION. The Office of Coordinated Outbreak Response
                and Evaluation Network is headed by the Director, Office of
                Coordinated Outbreak Response and Evaluation Network, and includes
                the following organizational units:
                Office of Food Additive Safety
                Signals and Analysis Staff
                 DCF. ORGANIZATION. The Center for Tobacco Products is headed by
                the Center Director.
                CENTER FOR TOBACCO PRODUCTS
                 DCFF. ORGANIZATION. The Center for Tobacco Products Office of
                Health Communication and Education is headed by the Director of
                Health Communication and Education and includes the following
                organizational units:
                Office of Health Communication and Education
                Division of Public Health Education
                Division of Regulatory Communication
                Division of Research and Evaluation
                 DCG. ORGANIZATION. The Center for Veterinary Medicine is headed
                by the Center Director.
                CENTER FOR VETERINARY MEDICINE
                 DCGB. ORGANIZATION. The Center for Veterinary Medicine Office of
                Management is headed by the Associate Director for Management and
                includes the following organizational units:
                Budget Planning and Evaluation Staff
                Business Informatics Staff
                Human Capital Management Staff
                Program and Resources Management Staff
                Talent Development Management Staff
                 DCGC. ORGANIZATION. The Center for Veterinary Medicine Office of
                New Animal Drug Evaluation is headed by the Director of New Animal
                Drug Evaluation and includes the following organizational units:
                Division of Animal Bioengineering and Cellular Therapies
                Division of Business Information Science and Management
                Division of Generic Animal Drugs
                Division of Human Food Safety
                Division of Manufacturing Technologies
                Division of Production Drugs
                Division of Scientific Support
                Division of Therapeutic Drugs for Food Animals
                Division of Therapeutic Drugs for Non-Food Animals
                 DCH. ORGANIZATION. The Oncology Center of Excellence is headed
                by the Director and includes the following organizational units:
                ONCOLOGY CENTER OF EXCELLENCE
                 DCI. ORGANIZATION. The Office of Regulatory Affairs is headed by
                the Associate Commissioner for Regulatory Affairs.
                OFFICE OF REGULATORY AFFAIRS
                 DCJ. ORGANIZATION. The Office of Clinical Policy and Programs is
                headed by the Director, Office of Clinical Policy and
                [[Page 22857]]
                Programs, and includes the following organizational units:
                OFFICE OF CLINICAL POLICY AND PROGRAMS
                Healthcare Provider Staff
                Patient Affairs Staff
                Office of Clinical Policy
                Good Clinical Practice Staff
                Office of Combination Products
                Office of Orphan Products Development
                Office of Pediatric Therapeutics
                 DCK. ORGANIZATION. The Office of External Affairs is headed by
                the Associate Commissioner for External Affairs and includes the
                following organizational units:
                OFFICE OF EXTERNAL AFFAIRS
                Operations Staff
                FDA History Office
                Stakeholder Engagement Staff
                Web & Digital Services Staff
                Office of Media Affairs
                Office of Editorial and Creative Services
                 DCL. ORGANIZATION. The Office of Food Policy and Response is
                headed by the Deputy Commissioner for Food Policy and Response, and
                includes the following organizational units:
                OFFICE OF FOOD POLICY AND RESPONSE
                Office of Resource Planning and Strategic Management
                 DCM. ORGANIZATION. The Office of Minority Health and Health
                Equity is headed by the Assistant Commissioner for Minority Health
                and Health Equity and includes the following organizational units:
                OFFICE OF MINORITY HEALTH AND HEALTH EQUITY
                 DCN. ORGANIZATION. The Office of Operations is headed by the
                Chief Operating Officer and includes the following organizational
                units:
                OFFICE OF OPERATIONS
                Office of Enterprise Management Services
                Program Effectiveness Staff
                Division of Compliance and Conflict Prevention
                Conflict Prevention and Resolution Staff
                Division of Human Capital
                Division of Information Governance
                Dockets Management Staff
                Division of Resource Management
                Division of Vendor Management
                Office of Equal Employment and Opportunity
                Compliance Staff
                Office of Ethics and Integrity
                Office of Facilities, Engineering and Mission Support Services
                Jefferson Laboratories Complex Staff
                Facilities Program Staff
                Employee Safety and Occupational Health Staff
                Division of Operations Management and Community Relations
                Logistics and Transportation Management Branch
                Facilities Maintenance and Operations Branch
                Auxiliary Program Management Staff
                Division of Planning, Engineering and Space Management
                Portfolio and Space Management Branch
                Engineering Management Branch
                Office of Finance, Budget, and Acquisitions
                Business Management Services Staff
                Office of Acquisitions and Grants Services
                Division of Acquisition Operations
                Service Contracts Branch
                Contracts Operations Branch
                Division of Acquisition Programs
                Scientific Support Branch
                Field Operations Branch
                Facilities Support Branch
                Division of State Acquisitions, Agreements and Grants
                Grants and Assistance Agreements Branch
                ORA Inspection Branch
                CTP Inspection Branch
                Division of Information Technology Acquisitions
                Information Technology Acquisitions Branch
                Systems Technology Acquisitions Branch
                Information Technology Strategic Support Branch
                Division of Policy, Systems and Program Support
                Training and Development Branch
                Acquisitions Policy and Oversight Branch
                Office of Budget
                Division of Budget Formulation and Program Alignment
                Division of Budget Execution and Control
                Office of Financial Management
                Financial Systems Support Staff
                Division of Accounting
                Division of Controls, Compliance and Oversight
                Division of Payment Services
                Division of Travel Services
                Field Operations Staff
                Division of User Fees
                Office of Human Capital Management
                Business Operations Staff
                Management and Administrative Inquiries Staff
                Performance Management and Awards Staff
                Division of FDA Training and Development
                Organization Development and Learning Solutions Branch
                Training Delivery and Program Operations Branch
                Division of Human Resources Systems and Operations Support
                Data Quality and Services Management Branch
                Human Resources Information Systems and Records Branch
                Human Resources Information Technology Branch
                Retirement and Benefits Branch
                Timekeeping and Payroll Services Branch
                Division of Employee and Labor Relations
                Employee Relations Branch I
                Employee Relations Branch II
                Labor Relations Branch
                Division of Strategic Talent Management Programs
                Workforce Support and Development Branch
                Quality of Work-life Programs Branch
                Office of Information Management and Technology
                Office of Information Management
                Office of Information Security
                Office of Technology and Delivery
                Delivery Management and Support Staff
                Division of Infrastructure Operations
                Infrastructure Management Services Staff
                Implementation Branch
                Infrastructure Engineering Branch
                Systems Monitoring & Response Branch
                Systems Operations Branch
                Network & Communications Operations Branch
                Division of Application Services
                Application Management Services Staff
                Data Management & Operations Branch
                Medical Products Branch
                OC/CVM/CTP Branch
                ORA/CFSAN Branch
                Enterprise Applications Branch
                Office of Business & Customer Assurance
                Division of Business Partnership & Support
                Internet & Intranet Branch
                Call Center Branch
                Regional Support Branch
                Property, Receiving & Distribution Branch
                Employee Resource and Information Center
                Division of Management Services
                Office of Enterprise Portfolio Management
                Office of Informatics & Technology Innovation
                Informatics Staff
                Knowledge Management Staff
                Enterprise Architecture Staff
                Office of Planning and Evaluation
                Planning Staff
                Program Evaluation and Process Improvement Staff
                Office of Security and Emergency Management
                Office of Security Operations
                Office of Emergency Management
                Emergency Planning, Exercises and Evaluation Staff
                Program Operations and Coordination Staff
                Office of Emergency Operations
                Office of Talent Solutions
                Commission Corps Staff
                Executive Resources Staff
                Policy and Accountability Staff
                Scientific Talent Recruitment Staff
                Division of Talent Services I
                CDER Branch A
                CDER Branch B
                CDER Branch C
                Division of Talent Services II
                CFSAN and CVM Branch
                OC and National Center for Toxicological Research Branch
                OO Branch
                Division of Talent Services III
                CBER Branch
                CDRH Branch
                CTP Branch
                Division of Talent Services IV
                ORA Branch A
                ORA Branch B
                ORA Branch C
                Division of Talent Sourcing and Staffing
                Corporate Recruitment & Title 38 Branch
                Scientific Staffing & Outreach Branch
                Customer Care and Data Quality Branch
                 DCO. ORGANIZATION. The Office of Policy, Legislation, and
                International Affairs is headed by the Deputy Commissioner for
                Policy, Legislation, and International Affairs and includes the
                following organizational units:
                OFFICE OF POLICY, LEGISLATION, AND INTERNATIONAL AFFAIRS
                Intergovernmental Affairs Staff
                Management and Operations Staff
                Office of Congressional Appropriations
                Office of Economics and Analysis
                Office of Global Policy and Strategy
                Office of Global Diplomacy and Partnerships
                Office of Global Operations
                [[Page 22858]]
                Regional Field Office, China Office
                Regional Field Office, Europe Office
                Regional Field Office, India Office
                Regional Field Office, Latin America Office
                Office of Trade, Mutual Recognition and International Arrangements
                Office of Legislation
                Office of Policy
                Policy Engagement and Coordination Staff
                Regulations Editorial Staff
                Regulations Policy and Management Staff
                 DCP. ORGANIZATION. The Office of the Chief Scientist is headed
                by the Chief Scientist and includes the following organizational
                units:
                OFFICE OF THE CHIEF SCIENTIST
                Advisory Committee Oversight and Management Staff
                Office of Counter-Terrorism and Emerging Threats
                Office of Laboratory Safety
                Office of Regulatory Science and Innovation
                Office of Scientific Integrity
                Office of Scientific Professional Development
                National Center for Toxicological Research
                 DCQ. ORGANIZATION. The Office of Women's Health is headed by the
                Assistant Commissioner for Women's Health and includes the following
                organizational units:
                OFFICE OF WOMEN'S HEALTH
                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.
                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.
                Alex M. Azar, II,
                Secretary, HHS.
                [FR Doc. 2019-10431 Filed 5-17-19; 8:45 am]
                 BILLING CODE 4164-01-P