Office of the Commissioner; Statement of Organization, Functions, and Delegations of Authority, 34540-34542 [2017-15564]
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a final draft of the guidance was
submitted to the ICH Assembly and
endorsed by the regulatory agencies on
June 16, 2016.
Regulatory authorities approve drugs
that are demonstrated to be safe and
effective for human use. The meaning of
‘‘safe’’ has historically been interpreted
to mean that the benefits of the drug
outweigh its risks. This benefit-risk
assessment of pharmaceuticals is the
fundamental basis of regulatory
decision-making. In the last several
years, providing greater structure for the
benefit-risk assessment has been an
important topic in drug regulation. The
M4E guidance directs applicants to
include their conclusions on benefits
and risks in the Clinical Overview of
Module 2 of the Common Technical
Document (CTD) under section 2.5.6.
Although general guidance is provided
in the M4E guidance regarding the
expected content of section 2.5.6, no
further structure is suggested to aid
industry in developing the benefit-risk
assessment. As a result, regulators
observe a high degree of variability in
the approaches taken by applicants in
presenting this information. This
variability may not facilitate efficient
communication of industry views to
regulators. Although regulators and
industry have developed approaches for
structured benefit-risk assessment and
these approaches may take different
forms, there is a common thread evident
that can inform harmonization of the
format and structure of benefit-risk
assessments provided by applicants in
their regulatory submissions.
The revised M4E(R2) guidance
provides more specific guidance
regarding the format and structure of the
benefit-risk assessment in section 2.5.6.
Section 2.5.6 is divided into four
subsections: (1) Therapeutic context, (2)
Benefit, (3) Risk, and (4) Benefit-Risk
Assessment. Each subsection describes
the aspects that are most pertinent to the
benefit-risk assessment. This guidance
also lists characteristics that should be
considered when identifying and
describing key benefits and key risks of
the medicinal product. Recognizing that
there are many reasonable approaches
for conducting a benefit-risk assessment,
M4E(R2) does not specify a particular
approach to be used by industry.
However, the document does offer
specific guidance on the major elements
that should be included in the benefitrisk assessment. Furthermore, the
revised guidance does not dictate an
approach used by a regulator in
conducting a benefit-risk assessment.
This guidance also revises other
sections of the guidance for
clarification, given the proposed
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revisions in section 2.5.6. In addition,
the revised guidance changes the
numbering and the section headings for
consistency.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: July 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15534 Filed 7–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Office of the Commissioner; 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 (OC), and Office of
Operations (OO) have modified their
structures. This new organizational
structure was approved by the Secretary
of Health and Human Services on
SUMMARY:
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January 10, 2017 and effective on
February 11, 2017.
FOR FURTHER INFORMATION CONTACT:
Segaran Pillai, Ph.D., Director, Office of
Laboratory Science and Safety, Office of
the Commissioner, Food and Drug
Administration, White Oak Bldg. 1, Rm.
2218, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 240–
402–2856.
SUPPLEMENTARY INFORMATION: Part D,
Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, and 76 FR 45270, July 28,
2011) is amended to reflect the
reorganization of the Office of the
Commissioner and the Office of
Operations.
This reorganization establishes the
Office of Laboratory Science and Safety,
and will authorize the consolidation of
the laboratory science, safety functions,
and program activities across FDA
under one organizational component
that will report directly to the Office of
the Commissioner. The Employee Safety
and Environmental Management Staff
will be realigned from the Office of
Safety, Security and Crisis Management
to the Office of Laboratory Science and
Safety. As a result of the staff
realignment the Office of Safety,
Security and Crisis Management within
the Office of Operations will be re-titled
to the Office of Security and Emergency
Management. The Office of Crisis
Management within the newly titled
Office of Security and Emergency
Management will change its title to the
Office of Emergency Management.
Additionally, the Office of Security and
Emergency Management has established
the Emergency Planning, Evaluation,
and Exercise Staff, and the Program
Operations and Coordination Staff
within the Office of Emergency
Management.
The Food and Drug Administration,
Office of the Commissioner (OC), has
been restructured as follows:
DA. 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 (DA)
Office of the Chief Counsel (DAA)
Office of the Executive Secretariat
(DAB)
Executive Secretariat Staff (DAB1)
Freedom of Information Staff (DAB2)
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Dockets Management Staff (DAB3)
Office of the Chief Scientist (DAE)
National Center for Toxicological
Research (DAEC)
Office of the Center Director (DAECA)
Office of Management (DAECB)
Planning and Resource Management
Staff (DAECBA)
Office of Research (DAECC)
Division of Biochemical Toxicology
(DAECCA)
Division of Genetic and Molecular
Toxicology (DAECCB)
Genetic Toxicology Lab (DAECCB1)
Division of Microbiology (DAECCD)
Division of Systems Biology (DAECCE)
Division of Neurotoxicology (DAECCF)
Division of Bioinformatics and
Biostatistics (DAECCH)
Office of Scientific Coordination
(DAECF)
Office of Counter-Terrorism and
Emerging Threats (DAEG)
Office of Scientific Integrity (DAEH)
Office of Regulatory Science and
Innovation (DAEI)
Division of Science Innovation and
Critical Path (DAEIA)
Division of Scientific Computing and
Medical Information (DAEIB)
Office of Scientific Professional
Development (DAEJ)
Office of Health Informatics (DAEK)
Office of the Counselor to the
Commissioner (DAR)
Office of Women’s Health (DAS)
Office of External Affairs (DAU)
Web and Digital Media Staff (DAU1)
Administrative Management Staff
(DAU2)
Office of Media Affairs (DAUA)
Web Communications Staff (DAUA2)
Office of Communications (DAUB)
Communications Staff (DAUB1)
FDA History Office (DAUB2)
Office of Health and Constituent Affairs
(DAUC)
Office of Minority Health (DAY)
Office of Laboratory Science and Safety
(DAZ)
Employee Safety and Environmental
Management Staff (DAZ1)
The Food and Drug Administration,
Office of Operations (OO), has been
restructured as follows:
DMM. ORGANIZATION. The Office of
Operations is headed by the Deputy
Commissioner for Operations and Chief
Operating Officer and includes the
following organizational units:
Office of Operations (DMM)
Office of Business Services (DMM1)
Business Operations Staff (DMM11)
Employee Resource and Information
Center (DMM1A)
Division of Ethics and Integrity (DMM3)
Ombudsman and Conflict Prevention
and Resolutions Staff (DMM4)
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Office of Equal Employment
Opportunity (DMMA)
Compliance Staff (DMMA1)
Diversity Staff (DMMA3)
Office of Finance, Budget and
Acquisitions (DMMD)
Office of Budget (DMMDA)
Division of Budget Formulation
(DMMDAA)
Division of Budget Execution and
Control (DMMDAB)
Office of Acquisition and Grant Services
(DMMDB)
Division of Acquisition Operations
(DMMDBA)
Service Contract Branch (DMMDBA1)
Contract Operations Branch
(DMMDBA2)
Division of Acquisition Programs
(DMMDBB)
Scientific Support Branch (DMMDBB1)
Field Operations Branch (DMMDBB2)
Facilities Support Branch (DMMDBB3)
Division of Regulatory Inspections
Acquisitions and Grants and
Assistance Management (DMMDBC)
Grants Management Branch
(DMMDBC1)
Regulatory Inspections and Acquisitions
Branch (DMMDBC2)
Division of Information Technology
Acquisitions (DMMDBD)
Information Technology Acquisitions
Branch (DMMDBD1)
Systems Technology Acquisitions
Branch (DMMDBD2)
Division of Policy, Systems, and
Program Support (DMMDBE)
Office of Financial Operations and
Policy (DMMDC)
Office of Financial Management
(DMMDCA)
Internal Controls, Compliance and
Oversight Staff (DMMDCA1)
Business Transformation,
Administration and Management Staff
(DMMDCA2)
User Fee Staff (DMMDCA3)
Financial Systems Support Staff
(DMMDCA4)
Division of Accounting (DMMDCAB)
Division of Travel Services
(DMMDCAC)
Division of Payment Services
(DMMDCAD)
Office of Human Resources (DMME)
Commissioned Corps Affairs Staff
(DMME6)
Management Analysis Services Staff
(DMME7)
Business Operations Staff (DMME8)
Division of Workforce Relations
(DMMEB)
Employee and Labor Relations Branch I
(DMMEB1)
Employee and Labor Relations Branch II
(DMMEB2)
Division of Policy, Programs, and
Executive Resources (DMMEC)
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Policy Branch (DMMEC1)
Executive Resources Branch (DMMEC2)
Accountability Branch (DMMEC3)
Division of Enterprise Support Services
(DMMED)
Resources and Information Branch
(DMMED1)
Systems and Records Management
Branch (DMMED2)
Benefits Branch (DMMED3)
FDA University (DMMEF)
Division of Human Resource Services
for Office of the Commissioner/Office
of Operations (DMMEG)
Office of the Commissioner/NCTR
Customer Solutions Branch
(DMMEG1)
Office of Operations Customer Solutions
Branch (DMMEG2)
Division of Human Resource Services
for Office of Medical Products and
Tobacco (DMMEH)
CDRH Customer Solutions Branch
(DMMEH1)
CBER and NCTR Customer Solutions
Branch (DMMEH2)
CDER Customer Solutions Branch
(DMMEH3)
CTP Customer Solutions Branch
(DMMEH4)
Division of Human Resource Services
for the OFVM/OGROP (DMMEI)
CFSAN/CVM Customer Solutions
Branch (DMMEI1)
ORA/OIP Customer Solutions Branch
(DMMEI2)
Office of Facilities, Engineering, and
Mission Support Services (DMMF)
Jefferson Laboratories Complex Staff
(DMMF1)
Facilities Program Staff (DMMF2)
Division of Operations Management and
Community Relations (DMMFA)
Logistics and Transportation
Management Branch (DMMFA1)
Facilities Maintenance and Operations
Branch (DMMFA2)
Auxiliary Program Management Branch
(DMMFA3)
Division of Planning, Engineering and
Space Management (DMMFB)
Portfolio and Space Management
Branch (DMMFB1)
Engineering Management Branch
(DMMFB2)
Office of Information Management and
Technology (DMMH)
Office of Information Management
(DMMHA)
Information Security Staff (DMMHA1)
Knowledge Management Staff
(DMMHA2)
Enterprise Architecture and Technology
Innovation Staff (DMMHA3)
Office of Technology and Delivery
(DMMHAA)
Delivery Management and Support Staff
(DMMHAA1)
Divisions of Infrastructure Operations
(DMMHAAA)
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Infrastructure Management Services
Staff (DMMHAAA1)
Implementation Branch (DMMHAAA2)
Infrastructure Engineering Branch
(DMMHAAA3)
Systems Monitoring and Response
Branch (DMMHAAA4)
Systems Operations Branch
(DMMHAAA5)
Network and Communications
Operations Branch (DMMHAAA6)
Division of Application Services
(DMMHAAB)
Application Management Services Staff
(DMMHAAB1)
Data Management and Operations
Branch (DMMHAAB2)
Medical Products Branch
(DMMHAAB3)
OC/CVM/CTP Branch (DMMHAAB4)
ORA/CFSAN Branch (DMMHAAB5)
Enterprise Application Branch
(DMMHAAB6)
Division of Delivery Management and
Support (DMMHAAC)
Delivery Management Branch
(DMMHAAC1)
Process Management and Control
Branch (DMMHAAC2)
Office of Business and Customer
Assurance (DMMHAB)
Records, eDiscovery and Risk
Management Staff (DMMHAB1)
Division of Business Partnership and
Support (DMMHABA)
Internet and Intranet Branch
(DMMHABA1)
Call Center Branch (DMMHABA2)
Regional Support Branch (DMMHABA3)
Property, Receiving and Distribution
Branch (DMMHABA4)
Division of Management Services
(DMMHABB)
Internal Services and Response Branch
(DMMHABB2)
Acquisitions Services Branch
(DMMHABB3)
Human Capital and Visual Media
Branch (DMMHABB4)
Office of Enterprise Portfolio
Management (DMMHAC)
Office of Security and Emergency
Management (DMMJ)
Office of Security Operations (DMMJA)
Office of Emergency Management
(DMMJB)
Emergency Planning, Evaluation, and
Exercise Staff (DMMJB1)
Program Operations and Coordination
Staff (DMMJB2)
Office of Emergency Operations
(DMMJBA)
I. 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
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organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
II. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s Web site at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Dated: July 17, 2017.
Thomas E. Price,
Secretary of Health and Human Services.
[FR Doc. 2017–15564 Filed 7–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Information Technology
Advisory Committee; Call for
Applications
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Call for applications.
AGENCY:
The Office of the National
Coordinator for Health Information
Technology (ONC) is seeking
applications to the Health Information
Technology Advisory Committee.
SUPPLEMENTARY INFORMATION:
Name of Committee: Health
Information Technology Advisory
Committee.
General Function of the Committees:
The Health Information Technology
Advisory Committee (HITAC) shall
make recommendations to the National
Coordinator on a policy framework to
advance an interoperable health
information technology infrastructure.
The Health Information Technology
Advisory Committee shall recommend
to the National Coordinator a policy
framework for adoption by the Secretary
consistent with the strategic plan under
section 3001(c)(3) for advancing the
following target areas (described in
more detail in the Description of Duties
section): (1) Achieving a health
information technology infrastructure
that allows for the electronic access,
exchange, and use of health
information; (2) the promotion and
protection of privacy and security of
health information in health
information technology; (3) the
facilitation of secure access by an
SUMMARY:
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individual to such individual’s
protected health information; and (4)
any other target area that the HITAC
identifies as an appropriate target area
to be considered. Such policy
framework shall seek to prioritize
achieving advancements in these target
areas and may incorporate policy
recommendations made by the HIT
Policy Committee, as in existence before
the date of the enactment of the 21st
Century Cures Act.
Date and Time: Applications must be
received by 12:00 p.m. on Friday,
August 4, 2017.
Contact Person: Michelle Consolazio,
email: michelle.consolazio @hhs.gov.
Background: Section 3002 of the 21st
Century Cures Act (Pub. L. 114–255)
establishes the Health Information
Technology Advisory Committee
(referred to as the ‘‘HITAC’’). Once
established, the Health Information
Technology Advisory Committee will be
governed by the provisions of the
Federal Advisory Committee Act
(FACA) (Pub. L. 92–463), as amended,
(5 U.S.C. App.), which sets forth
standards for the formation and use of
federal advisory committees. HHS is
seeking applications for two members
ofthe HITAC; one of whom shall be
appointed to be a public health official
representative. Members of the HITAC
shall at least reflect providers, ancillary
healthcare workers, consumers,
purchasers, health plans, technology
vendors, researchers, relevant Federal
agencies, and individuals with technical
expertise on health care quality, privacy
and security, and on the electronic
exchange and use of health information.
Members will be selected in order to
achieve a balanced representation of
viewpoints, areas of experience, subject
matter expertise, and representation of
the health care landscape. Terms will be
three (3) years from the appointment
date. Members serve without pay, but
will be provided per diem and travel
costs for committee services.
Submitting Applications:
Applications should be submitted
electronically through the application
database on the HealthiT.gov Web site
at: https://U www.healthit.gov/facas/
faca-workgroup-membershipapplication. An application package
must include: A short bio, a current
resume or CV including contact
information, and two letters of support.
Dated: July 10, 2017.
Michelle Consolazio,
Office of Policy, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. 2017–15565 Filed 7–24–17; 8:45 am]
BILLING CODE 4150–45–P
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]]>Agencies
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34540-34542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15564]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Office of the Commissioner; 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 (OC), and Office of Operations (OO) have modified their
structures. This new organizational structure was approved by the
Secretary of Health and Human Services on January 10, 2017 and
effective on February 11, 2017.
FOR FURTHER INFORMATION CONTACT: Segaran Pillai, Ph.D., Director,
Office of Laboratory Science and Safety, Office of the Commissioner,
Food and Drug Administration, White Oak Bldg. 1, Rm. 2218, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-2856.
SUPPLEMENTARY INFORMATION: Part D, Chapter D-B, (Food and Drug
Administration), the Statement of Organization, Functions, and
Delegations of Authority for the Department of Health and Human
Services (35 FR 3685, February 25, 1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, 74 FR 41713,
August 18, 2009, and 76 FR 45270, July 28, 2011) is amended to reflect
the reorganization of the Office of the Commissioner and the Office of
Operations.
This reorganization establishes the Office of Laboratory Science
and Safety, and will authorize the consolidation of the laboratory
science, safety functions, and program activities across FDA under one
organizational component that will report directly to the Office of the
Commissioner. The Employee Safety and Environmental Management Staff
will be realigned from the Office of Safety, Security and Crisis
Management to the Office of Laboratory Science and Safety. As a result
of the staff realignment the Office of Safety, Security and Crisis
Management within the Office of Operations will be re-titled to the
Office of Security and Emergency Management. The Office of Crisis
Management within the newly titled Office of Security and Emergency
Management will change its title to the Office of Emergency Management.
Additionally, the Office of Security and Emergency Management has
established the Emergency Planning, Evaluation, and Exercise Staff, and
the Program Operations and Coordination Staff within the Office of
Emergency Management.
The Food and Drug Administration, Office of the Commissioner (OC),
has been restructured as follows:
DA. 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 (DA)
Office of the Chief Counsel (DAA)
Office of the Executive Secretariat (DAB)
Executive Secretariat Staff (DAB1)
Freedom of Information Staff (DAB2)
[[Page 34541]]
Dockets Management Staff (DAB3)
Office of the Chief Scientist (DAE)
National Center for Toxicological Research (DAEC)
Office of the Center Director (DAECA)
Office of Management (DAECB)
Planning and Resource Management Staff (DAECBA)
Office of Research (DAECC)
Division of Biochemical Toxicology (DAECCA)
Division of Genetic and Molecular Toxicology (DAECCB)
Genetic Toxicology Lab (DAECCB1)
Division of Microbiology (DAECCD)
Division of Systems Biology (DAECCE)
Division of Neurotoxicology (DAECCF)
Division of Bioinformatics and Biostatistics (DAECCH)
Office of Scientific Coordination (DAECF)
Office of Counter-Terrorism and Emerging Threats (DAEG)
Office of Scientific Integrity (DAEH)
Office of Regulatory Science and Innovation (DAEI)
Division of Science Innovation and Critical Path (DAEIA)
Division of Scientific Computing and Medical Information (DAEIB)
Office of Scientific Professional Development (DAEJ)
Office of Health Informatics (DAEK)
Office of the Counselor to the Commissioner (DAR)
Office of Women's Health (DAS)
Office of External Affairs (DAU)
Web and Digital Media Staff (DAU1)
Administrative Management Staff (DAU2)
Office of Media Affairs (DAUA)
Web Communications Staff (DAUA2)
Office of Communications (DAUB)
Communications Staff (DAUB1)
FDA History Office (DAUB2)
Office of Health and Constituent Affairs (DAUC)
Office of Minority Health (DAY)
Office of Laboratory Science and Safety (DAZ)
Employee Safety and Environmental Management Staff (DAZ1)
The Food and Drug Administration, Office of Operations (OO), has
been restructured as follows:
DMM. ORGANIZATION. The Office of Operations is headed by the Deputy
Commissioner for Operations and Chief Operating Officer and includes
the following organizational units:
Office of Operations (DMM)
Office of Business Services (DMM1)
Business Operations Staff (DMM11)
Employee Resource and Information Center (DMM1A)
Division of Ethics and Integrity (DMM3)
Ombudsman and Conflict Prevention and Resolutions Staff (DMM4)
Office of Equal Employment Opportunity (DMMA)
Compliance Staff (DMMA1)
Diversity Staff (DMMA3)
Office of Finance, Budget and Acquisitions (DMMD)
Office of Budget (DMMDA)
Division of Budget Formulation (DMMDAA)
Division of Budget Execution and Control (DMMDAB)
Office of Acquisition and Grant Services (DMMDB)
Division of Acquisition Operations (DMMDBA)
Service Contract Branch (DMMDBA1)
Contract Operations Branch (DMMDBA2)
Division of Acquisition Programs (DMMDBB)
Scientific Support Branch (DMMDBB1)
Field Operations Branch (DMMDBB2)
Facilities Support Branch (DMMDBB3)
Division of Regulatory Inspections Acquisitions and Grants and
Assistance Management (DMMDBC)
Grants Management Branch (DMMDBC1)
Regulatory Inspections and Acquisitions Branch (DMMDBC2)
Division of Information Technology Acquisitions (DMMDBD)
Information Technology Acquisitions Branch (DMMDBD1)
Systems Technology Acquisitions Branch (DMMDBD2)
Division of Policy, Systems, and Program Support (DMMDBE)
Office of Financial Operations and Policy (DMMDC)
Office of Financial Management (DMMDCA)
Internal Controls, Compliance and Oversight Staff (DMMDCA1)
Business Transformation, Administration and Management Staff (DMMDCA2)
User Fee Staff (DMMDCA3)
Financial Systems Support Staff (DMMDCA4)
Division of Accounting (DMMDCAB)
Division of Travel Services (DMMDCAC)
Division of Payment Services (DMMDCAD)
Office of Human Resources (DMME)
Commissioned Corps Affairs Staff (DMME6)
Management Analysis Services Staff (DMME7)
Business Operations Staff (DMME8)
Division of Workforce Relations (DMMEB)
Employee and Labor Relations Branch I (DMMEB1)
Employee and Labor Relations Branch II (DMMEB2)
Division of Policy, Programs, and Executive Resources (DMMEC)
Policy Branch (DMMEC1)
Executive Resources Branch (DMMEC2)
Accountability Branch (DMMEC3)
Division of Enterprise Support Services (DMMED)
Resources and Information Branch (DMMED1)
Systems and Records Management Branch (DMMED2)
Benefits Branch (DMMED3)
FDA University (DMMEF)
Division of Human Resource Services for Office of the Commissioner/
Office of Operations (DMMEG)
Office of the Commissioner/NCTR Customer Solutions Branch (DMMEG1)
Office of Operations Customer Solutions Branch (DMMEG2)
Division of Human Resource Services for Office of Medical Products and
Tobacco (DMMEH)
CDRH Customer Solutions Branch (DMMEH1)
CBER and NCTR Customer Solutions Branch (DMMEH2)
CDER Customer Solutions Branch (DMMEH3)
CTP Customer Solutions Branch (DMMEH4)
Division of Human Resource Services for the OFVM/OGROP (DMMEI)
CFSAN/CVM Customer Solutions Branch (DMMEI1)
ORA/OIP Customer Solutions Branch (DMMEI2)
Office of Facilities, Engineering, and Mission Support Services (DMMF)
Jefferson Laboratories Complex Staff (DMMF1)
Facilities Program Staff (DMMF2)
Division of Operations Management and Community Relations (DMMFA)
Logistics and Transportation Management Branch (DMMFA1)
Facilities Maintenance and Operations Branch (DMMFA2)
Auxiliary Program Management Branch (DMMFA3)
Division of Planning, Engineering and Space Management (DMMFB)
Portfolio and Space Management Branch (DMMFB1)
Engineering Management Branch (DMMFB2)
Office of Information Management and Technology (DMMH)
Office of Information Management (DMMHA)
Information Security Staff (DMMHA1)
Knowledge Management Staff (DMMHA2)
Enterprise Architecture and Technology Innovation Staff (DMMHA3)
Office of Technology and Delivery (DMMHAA)
Delivery Management and Support Staff (DMMHAA1)
Divisions of Infrastructure Operations (DMMHAAA)
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Infrastructure Management Services Staff (DMMHAAA1)
Implementation Branch (DMMHAAA2)
Infrastructure Engineering Branch (DMMHAAA3)
Systems Monitoring and Response Branch (DMMHAAA4)
Systems Operations Branch (DMMHAAA5)
Network and Communications Operations Branch (DMMHAAA6)
Division of Application Services (DMMHAAB)
Application Management Services Staff (DMMHAAB1)
Data Management and Operations Branch (DMMHAAB2)
Medical Products Branch (DMMHAAB3)
OC/CVM/CTP Branch (DMMHAAB4)
ORA/CFSAN Branch (DMMHAAB5)
Enterprise Application Branch (DMMHAAB6)
Division of Delivery Management and Support (DMMHAAC)
Delivery Management Branch (DMMHAAC1)
Process Management and Control Branch (DMMHAAC2)
Office of Business and Customer Assurance (DMMHAB)
Records, eDiscovery and Risk Management Staff (DMMHAB1)
Division of Business Partnership and Support (DMMHABA)
Internet and Intranet Branch (DMMHABA1)
Call Center Branch (DMMHABA2)
Regional Support Branch (DMMHABA3)
Property, Receiving and Distribution Branch (DMMHABA4)
Division of Management Services (DMMHABB)
Internal Services and Response Branch (DMMHABB2)
Acquisitions Services Branch (DMMHABB3)
Human Capital and Visual Media Branch (DMMHABB4)
Office of Enterprise Portfolio Management (DMMHAC)
Office of Security and Emergency Management (DMMJ)
Office of Security Operations (DMMJA)
Office of Emergency Management (DMMJB)
Emergency Planning, Evaluation, and Exercise Staff (DMMJB1)
Program Operations and Coordination Staff (DMMJB2)
Office of Emergency Operations (DMMJBA)
I. 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.
II. Electronic Access
This reorganization is reflected in FDA's Staff Manual Guide (SMG).
Persons interested in seeing the complete Staff Manual Guide can find
it on FDA's Web site at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Dated: July 17, 2017.
Thomas E. Price,
Secretary of Health and Human Services.
[FR Doc. 2017-15564 Filed 7-24-17; 8:45 am]
BILLING CODE 4164-01-P
