Statement of Organization, Functions, and Delegations of Authority, 22854-22858 [2019-10431]
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[FR Doc. 2019–10418 Filed 5–17–19; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (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:
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SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970; 60 FR 56606, November 9, 1995;
64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August
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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
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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; Summarylevel Review and Inter-Center Institutes;
as well as other initiatives. The Office
of Hematology and Oncology Products
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0662]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Applications for
Food and Drug Administration
Approval To Market a New Drug:
Patent Submission and Listing
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on reporting
requirements for submission and listing
of patent information associated with a
new drug application (NDA), an
amendment or a supplement to an NDA.
DATES: Submit either electronic or
written comments on the collection of
information by July 19, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 19, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 19, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
PO 00000
Frm 00053
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confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0662 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Applications for Food and Drug
Administration Approval to Market a
New Drug: Patent Submission and
Listing Requirements.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (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
