82 FR 34540 - Office of the Commissioner; Statement of Organization, Functions, and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 141 (July 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 141 (July 25, 2017)
| Page Range | 34540-34542 | |
| FR Document | 2017-15564 |
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)] [Notices] [Pages 34540-34542] From the Federal Register Online [www.thefederalregister.org] [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) [[Page 34542]] 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
![34540 Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
a final draft of the guidance was revisions in section 2.5.6. In addition, January 10, 2017 and effective on
submitted to the ICH Assembly and the revised guidance changes the February 11, 2017.
endorsed by the regulatory agencies on numbering and the section headings for FOR FURTHER INFORMATION CONTACT:
June 16, 2016. consistency. Segaran Pillai, Ph.D., Director, Office of
Regulatory authorities approve drugs This guidance is being issued Laboratory Science and Safety, Office of
that are demonstrated to be safe and consistent with FDA’s good guidance the Commissioner, Food and Drug
effective for human use. The meaning of practices regulation (21 CFR 10.115). Administration, White Oak Bldg. 1, Rm.
‘‘safe’’ has historically been interpreted The guidance represents the current 2218, 10903 New Hampshire Ave.,
to mean that the benefits of the drug thinking of FDA on this topic. It does Silver Spring, MD 20993–0002, 240–
outweigh its risks. This benefit-risk not establish any rights for any person 402–2856.
assessment of pharmaceuticals is the and is not binding on FDA or the public. SUPPLEMENTARY INFORMATION: Part D,
fundamental basis of regulatory You can use an alternative approach if Chapter D–B, (Food and Drug
decision-making. In the last several it satisfies the requirements of the Administration), the Statement of
years, providing greater structure for the applicable statutes and regulations. This Organization, Functions, and
benefit-risk assessment has been an guidance is not subject to Executive Delegations of Authority for the
important topic in drug regulation. The Order 12866. Department of Health and Human
M4E guidance directs applicants to
include their conclusions on benefits II. Paperwork Reduction Act of 1995 Services (35 FR 3685, February 25,
and risks in the Clinical Overview of 1970, 60 FR 56606, November 9, 1995,
This guidance refers to previously 64 FR 36361, July 6, 1999, 72 FR 50112,
Module 2 of the Common Technical approved collections of information that
Document (CTD) under section 2.5.6. August 30, 2007, 74 FR 41713, August
are subject to review by the Office of 18, 2009, and 76 FR 45270, July 28,
Although general guidance is provided
Management and Budget (OMB) under 2011) is amended to reflect the
in the M4E guidance regarding the
the Paperwork Reduction Act of 1995 reorganization of the Office of the
expected content of section 2.5.6, no
(44 U.S.C. 3501–3520). The collections Commissioner and the Office of
further structure is suggested to aid
of information in 21 CFR parts 312 and Operations.
industry in developing the benefit-risk
314 have been approved under OMB This reorganization establishes the
assessment. As a result, regulators
control numbers 0910–0014 and 0910– Office of Laboratory Science and Safety,
observe a high degree of variability in
0001, respectively. and will authorize the consolidation of
the approaches taken by applicants in
presenting this information. This III. Electronic Access the laboratory science, safety functions,
variability may not facilitate efficient and program activities across FDA
communication of industry views to Persons with access to the Internet under one organizational component
regulators. Although regulators and may obtain the guidance at https:// that will report directly to the Office of
industry have developed approaches for www.regulations.gov, http:// the Commissioner. The Employee Safety
structured benefit-risk assessment and www.fda.gov/Drugs/Guidance and Environmental Management Staff
these approaches may take different ComplianceRegulatoryInformation/ will be realigned from the Office of
forms, there is a common thread evident Guidances/default.htm, or http:// Safety, Security and Crisis Management
that can inform harmonization of the www.fda.gov/BiologicsBloodVaccines/ to the Office of Laboratory Science and
format and structure of benefit-risk GuidanceCompliance Safety. As a result of the staff
assessments provided by applicants in RegulatoryInformation/Guidances/ realignment the Office of Safety,
their regulatory submissions. default.htm. Security and Crisis Management within
The revised M4E(R2) guidance Dated: July 18, 2017. the Office of Operations will be re-titled
provides more specific guidance Anna K. Abram, to the Office of Security and Emergency
regarding the format and structure of the Deputy Commissioner for Policy, Planning,
Management. The Office of Crisis
benefit-risk assessment in section 2.5.6. Legislation, and Analysis. Management within the newly titled
Section 2.5.6 is divided into four [FR Doc. 2017–15534 Filed 7–24–17; 8:45 am]
Office of Security and Emergency
subsections: (1) Therapeutic context, (2) Management will change its title to the
BILLING CODE 4164–01–P
Benefit, (3) Risk, and (4) Benefit-Risk Office of Emergency Management.
Assessment. Each subsection describes Additionally, the Office of Security and
the aspects that are most pertinent to the DEPARTMENT OF HEALTH AND Emergency Management has established
benefit-risk assessment. This guidance HUMAN SERVICES the Emergency Planning, Evaluation,
also lists characteristics that should be and Exercise Staff, and the Program
considered when identifying and Food and Drug Administration Operations and Coordination Staff
describing key benefits and key risks of within the Office of Emergency
the medicinal product. Recognizing that Office of the Commissioner; Statement Management.
there are many reasonable approaches of Organization, Functions, and The Food and Drug Administration,
for conducting a benefit-risk assessment, Delegations of Authority Office of the Commissioner (OC), has
M4E(R2) does not specify a particular been restructured as follows:
approach to be used by industry. AGENCY: Food and Drug Administration, DA. ORGANIZATION. The Office of
However, the document does offer HHS. the Commissioner is headed by the
specific guidance on the major elements ACTION: Notice. Commissioner of Food and Drugs and
that should be included in the benefit- includes the following organizational
mstockstill on DSK30JT082PROD with NOTICES
risk assessment. Furthermore, the SUMMARY: The Food and Drug units:
revised guidance does not dictate an Administration (FDA), Office of the Office of the Commissioner (DA)
approach used by a regulator in Commissioner (OC), and Office of Office of the Chief Counsel (DAA)
conducting a benefit-risk assessment. Operations (OO) have modified their Office of the Executive Secretariat
This guidance also revises other structures. This new organizational (DAB)
sections of the guidance for structure was approved by the Secretary Executive Secretariat Staff (DAB1)
clarification, given the proposed of Health and Human Services on Freedom of Information Staff (DAB2)
VerDate Sep<11>2014 19:30 Jul 24, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/82_FR_34681/page/1.svg)
![34542 Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
Infrastructure Management Services organizational components will individual to such individual’s
Staff (DMMHAAA1) continue in them or their successors protected health information; and (4)
Implementation Branch (DMMHAAA2) pending further redelegations, provided any other target area that the HITAC
Infrastructure Engineering Branch they are consistent with this identifies as an appropriate target area
(DMMHAAA3) reorganization. to be considered. Such policy
Systems Monitoring and Response framework shall seek to prioritize
Branch (DMMHAAA4) II. Electronic Access
achieving advancements in these target
Systems Operations Branch This reorganization is reflected in areas and may incorporate policy
(DMMHAAA5) FDA’s Staff Manual Guide (SMG). recommendations made by the HIT
Network and Communications Persons interested in seeing the Policy Committee, as in existence before
Operations Branch (DMMHAAA6) complete Staff Manual Guide can find it the date of the enactment of the 21st
Division of Application Services on FDA’s Web site at: https:// Century Cures Act.
(DMMHAAB) www.fda.gov/AboutFDA/ Date and Time: Applications must be
Application Management Services Staff ReportsManualsForms/ received by 12:00 p.m. on Friday,
(DMMHAAB1) StaffManualGuides/default.htm. August 4, 2017.
Data Management and Operations Authority: 44 U.S.C. 3101. Contact Person: Michelle Consolazio,
Branch (DMMHAAB2) email: michelle.consolazio @hhs.gov.
Medical Products Branch Dated: July 17, 2017. Background: Section 3002 of the 21st
(DMMHAAB3) Thomas E. Price, Century Cures Act (Pub. L. 114–255)
OC/CVM/CTP Branch (DMMHAAB4) Secretary of Health and Human Services. establishes the Health Information
ORA/CFSAN Branch (DMMHAAB5) [FR Doc. 2017–15564 Filed 7–24–17; 8:45 am] Technology Advisory Committee
Enterprise Application Branch BILLING CODE 4164–01–P (referred to as the ‘‘HITAC’’). Once
(DMMHAAB6) established, the Health Information
Division of Delivery Management and Technology Advisory Committee will be
Support (DMMHAAC) DEPARTMENT OF HEALTH AND governed by the provisions of the
Delivery Management Branch HUMAN SERVICES Federal Advisory Committee Act
(DMMHAAC1) (FACA) (Pub. L. 92–463), as amended,
Process Management and Control Health Information Technology (5 U.S.C. App.), which sets forth
Branch (DMMHAAC2) Advisory Committee; Call for standards for the formation and use of
Office of Business and Customer Applications federal advisory committees. HHS is
Assurance (DMMHAB) AGENCY: Office of the National seeking applications for two members
Records, eDiscovery and Risk ofthe HITAC; one of whom shall be
Coordinator for Health Information
Management Staff (DMMHAB1) appointed to be a public health official
Technology, HHS.
Division of Business Partnership and representative. Members of the HITAC
Support (DMMHABA) ACTION: Call for applications.
shall at least reflect providers, ancillary
Internet and Intranet Branch SUMMARY: The Office of the National healthcare workers, consumers,
(DMMHABA1) Coordinator for Health Information purchasers, health plans, technology
Call Center Branch (DMMHABA2) Technology (ONC) is seeking vendors, researchers, relevant Federal
Regional Support Branch (DMMHABA3) agencies, and individuals with technical
applications to the Health Information
Property, Receiving and Distribution expertise on health care quality, privacy
Technology Advisory Committee.
Branch (DMMHABA4) and security, and on the electronic
Division of Management Services SUPPLEMENTARY INFORMATION:
Name of Committee: Health exchange and use of health information.
(DMMHABB) Members will be selected in order to
Internal Services and Response Branch Information Technology Advisory
Committee. achieve a balanced representation of
(DMMHABB2) viewpoints, areas of experience, subject
Acquisitions Services Branch General Function of the Committees:
The Health Information Technology matter expertise, and representation of
(DMMHABB3) the health care landscape. Terms will be
Human Capital and Visual Media Advisory Committee (HITAC) shall
make recommendations to the National three (3) years from the appointment
Branch (DMMHABB4) date. Members serve without pay, but
Office of Enterprise Portfolio Coordinator on a policy framework to
advance an interoperable health will be provided per diem and travel
Management (DMMHAC) costs for committee services.
Office of Security and Emergency information technology infrastructure.
Submitting Applications:
Management (DMMJ) The Health Information Technology
Applications should be submitted
Office of Security Operations (DMMJA) Advisory Committee shall recommend
electronically through the application
Office of Emergency Management to the National Coordinator a policy
database on the HealthiT.gov Web site
(DMMJB) framework for adoption by the Secretary
at: http://U www.healthit.gov/facas/
Emergency Planning, Evaluation, and consistent with the strategic plan under
faca-workgroup-membership-
Exercise Staff (DMMJB1) section 3001(c)(3) for advancing the
application. An application package
Program Operations and Coordination following target areas (described in
must include: A short bio, a current
Staff (DMMJB2) more detail in the Description of Duties
resume or CV including contact
Office of Emergency Operations section): (1) Achieving a health
information, and two letters of support.
(DMMJBA) information technology infrastructure
mstockstill on DSK30JT082PROD with NOTICES
that allows for the electronic access, Dated: July 10, 2017.
I. Delegations of Authority exchange, and use of health Michelle Consolazio,
Pending further delegation, directives, information; (2) the promotion and Office of Policy, Office of the National
or orders by the Commissioner of Food protection of privacy and security of Coordinator for Health Information
and Drugs, all delegations and health information in health Technology.
redelegations of authority made to information technology; (3) the [FR Doc. 2017–15565 Filed 7–24–17; 8:45 am]
officials and employees of affected facilitation of secure access by an BILLING CODE 4150–45–P
VerDate Sep<11>2014 19:30 Jul 24, 2017 Jkt 241001 PO 00000 Frm 00071 Fmt 4703 Sfmt 9990 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/82_FR_34681/page/3.svg)
Document Created: 2018-10-24 11:21:39
Document Modified: 2018-10-24 11:21:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 82 FR 34540 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR