Statement of Organization, Functions, and Delegations of Authority, 58807-58810 [2022-20996]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
Regulatory Review Branch 2 (DCBGKB1)
Review Management Support Branch 2
(DCBGKB2)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s website at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
(Authority: 44 U.S.C. 3101)
Dated: September 23, 2022.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2022–20997 Filed 9–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
Office of Regulatory Affairs,
Food and Drug Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Headquarters
(HQ) and Field Offices (RFO) have
modified its structure.
DATES: This new organizational
structure was approved by the Deputy
Secretary of Health and Human Services
on December 22, 2021, and became
effective on February 9, 2022.
FOR FURTHER INFORMATION CONTACT:
Glenda Barfell, Associate Commissioner
for Regulatory Management Operations,
Office of Regulatory Management
Operations, Office of Regulatory Affairs,
Food and Drug Administration, Element
Building, Room 2002, 12420 Parklawn
Drive, Rockville, MD 20857, Phone:
240–402–7562.
SUPPLEMENTARY INFORMATION: Part D,
Chapter D–B, (Food and Drug
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:06 Sep 27, 2022
Jkt 256001
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
amended to reflect the reorganization of
the Office of Regulatory Affairs
Headquarters Offices and Field Offices.
This reorganization is a continuation
of the Program Alignment (PA)
reorganization completed in 2017 to
enhance organizational efficiencies
identified after PA. The objective is to
improve the Office of Regulatory Affairs
(ORA) core functions, correct and
enhance the structure with effective use
of resources, and carry out the mission
of protecting consumers by ensuring
compliance of FDA-regulated products.
As industry rapidly changes, the FDA
must continue to evolve to ensure that
public health is not negatively impacted
by gaps in inspections and
investigations of regulated firms.
The Food and Drug Administration,
Office of Regulatory Affairs (ORA), has
been restructured as follows:
DCI. ORGANIZATION. The Office of
Regulatory Affairs is headed by the
Associate Commissioner for Regulatory
Affairs and includes the following
organizational units:
Office of Regulatory Affairs (DCI)
Office of the Associate Commissioner
for Regulatory Affairs (DCIA)
Data Analytics and Program Evaluation
Staff (DCIA1)
Office of Regulatory Management
Operations (DCIB)
Management Liaison Staff (DCIB1)
Office of Budget, Facilities, and Travel
Support (DCIBB)
Division of Financial Operations
(DCIBBA)
Budget Execution Branch (DCIBBA1)
Budget Formulation Branch (DCIBBA2)
Funds Control and Policy Branch
(DCIBBA3)
Work Planning Branch (DCIBBA4)
Division of Facilities and Property
Management (DCIBBBB)
Laboratory Support Branch (DCIBBBB1)
Real Property Management Branch East
(DCIBBB2)
Real Property Management Branch West
(DCIBBB3)
Fleet and Personal Property
Management Branch (DCIBBB4)
Division of Contracts and Grants
(DCIBBC)
State Contracts and Agreements Branch
(DCIBBC1)
Scientific Contracts and Agreements
Branch (DCIBBC2)
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
58807
Operational Contracts and Agreements
Branch (DCIBBC3)
Division of Travel Operations (DCIBBD)
Domestic Travel Branch (DCIBBD1)
Medical Products Travel Branch
(DCIBBD2)
Human and Animal Food Travel Branch
(DCIBBD3)
Travel Compliance Branch (DCIBBD4)
Office of Workforce Management
(DCIBC)
Executive and Scientific Recruitment
Staff (DCIBC1)
Division of Human Capital Staffing
Services (DCIBCA)
Talent Acquisitions Branch 1
(DCIBCA1)
Talent Acquisitions Branch 2
(DCIBCA2)
Talent Acquisitions Branch 3
(DCIBCA3)
Talent Acquisitions Branch 4
(DCIBCA4)
Talent Acquisitions Branch 5
(DCIBCA5)
Special Hiring Branch (DCIBCA6)
Classification and Reorganization
Branch (DCIBCA7)
Division of Human Capital Programs
(DCIBCB)
Performance Management Branch
(DCIBCB1)
Employee Engagement Branch
(DCIBCB2)
Management Analysis Branch
(DCIBCB3)
Office of Training, Education and
Development (DCIBF)
Quality and Records Management Staff
(DCIBF1)
Division of Programmatic Training
(DCIBFA)
Programmatic Training Branch 1
(DCIBFA1)
Programmatic Training Branch 2
(DCIBFA2)
Division of Multi-Program, Leadership
and Management Training (DCIBFB)
Multi-Program Leadership and
Management Branch (DCIBFB1)
Leadership, Management, and
Mentoring Training Branch
(DCIBFB2)
Division of Instructional Systems and
Technology (DCIBFC)
Instructional Systems Branch (DCIBFC1)
Learning Management Technology and
Multimedia Branch (DCIBFC2)
Division of Testing, Measurement,
Certification, and Program Analysis
(DCIBFD)
Test, Measurement, and Analysis
Branch (DCIBFD1)
Certification Branch (DCIBFD2)
Office of Criminal Investigations (DCIC)
Metro Washington Field Office (DCICA)
Philadelphia Resident Unit (DCICA1)
Chicago Field Office (DCICB)
New York Field Office (DCICC)
E:\FR\FM\28SEN1.SGM
28SEN1
lotter on DSK11XQN23PROD with NOTICES1
58808
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
Boston, MA Resident Unit (DCICC1)
Los Angeles Field Office (DCICD)
San Francisco, CA Resident Unit
(DCICD1)
Miami Field Office (DCICE)
San Juan, PR Resident Unit (DCICE1)
Atlanta, GA Resident Unit (DCICE2)
New Orleans, LA Resident Unit
(DCICE3)
Kansas City Field Office (DCICF)
Dallas, TX Resident Unit (DCICF1)
Office of Communications and Project
Management (DCID)
Executive Secretariat Staff (DCID2)
Division of Communications (DCIDA)
Public Affairs Branch (DCIDA1)
Web and Digital Media Branch
(DCIDA2)
Strategic Communications Branch
(DCIDA3)
Division of Project Management
(DCIDB)
Project Management Resource Branch
(DCIDB1)
Project Management Branch 1 (DCIDB1)
Project Management Branch 2 (DCIDB2)
Office of Human and Animal Food
Operations (DCIE)
Audit Staff (DCIE1)
Office of State Cooperative Programs
(DCIEA)
Division of Retail Food Protection
(DCIEAA)
Retail Food Protection Branch 1
(DCIEAA1)
Retail Food Protection Branch 2
(DCIEAA2)
Retail Food Protection Branch 3
(DCIEAA3)
Division of Milk Safety (DCIEAB)
Milk Safety Branch 1 (DCIEAB1)
Milk Safety Branch 2 (DCIEAB2)
Milk Safety Branch 3 (DCIEAB3)
Division of Shellfish Sanitation
(DCIEAC)
Shellfish Sanitation Branch 1
(DCIEAC1)
Shellfish Sanitation Branch 2
(DCIEAC2)
Office of Human and Animal Food
Operations East (DCIEB)
Division of Foreign Human and Animal
Food Operations (DCIEBA)
Foreign Human and Animal Food
Inspections Branch 1 (DCIEBA)
Foreign Human and Animal Food
Inspections Branch 2 (DCIEBA2)
Foreign Human and Animal Food
Operations Branch (DCIEBA3)
Foreign Human and Animal Food
Inspections Planning Branch
(DCIEBA4)
Division of Human and Animal Food
Operations East I (DCIEBB)
Human and Animal Food Investigations
Branch (DCIEBB1)
Human and Animal Food Compliance
Branch (DCIEBB2)
Division of Human and Animal Food
Operations East II (DCIEBC)
VerDate Sep<11>2014
18:06 Sep 27, 2022
Jkt 256001
Human and Animal Food Investigations
Branch (DCIEBC1)
Human and Animal Food Compliance
Branch (DCIEBC2)
Division of Human and Animal Food
Operations East III (DCIEBD)
Human and Animal Food Investigations
Branch (DCIEBD1)
Human and Animal Food Compliance
Branch (DCIEBD2)
Division of Human and Animal Food
Operations East IV (DCIEBE)
Human and Animal Food Investigations
Branch (DCIEBE1)
Human and Animal Food Compliance
Branch (DCIEBE2)
Division of Human and Animal Food
Operations East V (DCIEBF)
Human and Animal Food Investigations
Branch 1 (DCIEBF1)
Human and Animal Food Investigations
Branch 2 (DCIEBF2)
Human and Animal Food Compliance
Branch (DCIEBF3)
Division of Human and Animal Food
Operations East VI (DCIEBG)
Human and Animal Food Investigations
Branch (DCIEBG1)
Human and Animal Food Compliance
Branch (DCIEBG2)
Office of Human and Animal Food
Operations West (DCIEC)
Division of Domestic Human and
Animal Food Operations (DCIECA)
Domestic Human and Animal Food
Operations Branch (DCIECA1)
Domestic Produce Safety Branch 1
(DCIECA2)
Domestic Produce Safety Branch 2
(DCIECA3)
Division of Human and Animal Food
Operations West I (DCIECB)
Human and Animal Food Investigations
Branch (DCIECB1)
Human and Animal Food Compliance
Branch (DCIECB2)
Division of Human and Animal Food
Operations West II (DCIECC)
Human and Animal Food Investigations
Branch (DCIECC1)
Human and Animal Food Compliance
Branch (DCIECC2)
Division of Human and Animal Food
Operations West III (DCIECD)
Human and Animal Food Investigations
Branch (DCIECD1)
Human and Animal Food Compliance
Branch (DCIECD2)
Division of Human and Animal Food
Operations West IV (DCIECE)
Human and Animal Food Investigations
Branch (DCIECE1)
Human and Animal Food Compliance
Branch (DCIECE2)
Division of Human and Animal Food
Operations West V (DCIECF)
Human and Animal Food Investigations
Branch 1 (DCIECF1)
Human and Animal Food Investigations
Branch 2 (DCIECF2)
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Human and Animal Food Compliance
Branch (DCIECF3)
Division of Human and Animal Food
Operations West VI (DCIECG)
Human and Animal Food Investigations
Branch (DCIECG1)
Human and Animal Food Compliance
Branch (DCIECG2)
Office of Regulatory Science (DCIF)
Informatics and Business Operations
Staff (DCIF1)
Office of Research, Coordination,
Evaluation, and Training (DCIFA)
Scientific Research Staff (DCIFA1)
Evaluation Staff (DCIFA2)
Office of Medical Products and
Specialty Laboratory Operations
(DCIFB)
Medical Products and Tobacco
Scientific Staff (DCIFB1)
Forensic Chemistry Center (DCIFBA)
Inorganic Branch (DCIFBA1)
Organic Branch (DCIFBA2)
Satellite Laboratory Branch (DCIFBA3)
Winchester Engineering and Analytical
Center (DCIFBB)
Analytical Branch (DCIFBB1)
Engineering Branch (DCIFBB2)
Detroit Medical Products Laboratory
(DCIFBC)
New York Medical Products Laboratory
(DCIFBD)
Irvine Medical Products Laboratory
(DCIFBE)
Philadelphia Medical Products
Laboratory (DCIFBF)
San Juan Medical Products Laboratory
(DCIFBG)
Tobacco Products Laboratory (DCIFBH)
Office of Human and Animal Foods
Laboratory Operations (DCIFC)
Human and Animal Food Scientific
Staff (DCIFC1)
Arkansas Human and Animal Food
Laboratory (DCIFCA)
Chemistry Branch 1 (DCIFCA1)
Chemistry Branch 2 (DCIFCA2)
Microbiology Branch (DCIFCA3)
Denver Human and Animal Food
Laboratory (DCIFCB)
Chemistry Branch (DCIFCB1)
Microbiology Branch (DCIFCB2)
Kansas City Human and Animal Food
Laboratory (DCIFCC)
Chemistry Branch 1 (DCIFCC1)
Chemistry Branch 2 (DCIFCC2)
New York Human and Animal Food
Laboratory (DCIFCD)
Chemistry Branch (DCIFCD1)
Microbiological Sciences Branch
(DCIFCD2)
Seattle Human and Animal Food
Laboratory (DCIFCE)
Chemistry Branch (DCIFCE1)
Microbiology Branch (DCIFCE2)
Applied Technology Branch (DCIFCE3)
San Francisco Human and Animal Food
Laboratory (DCIFCF)
Chemistry Branch (DCIFCF1)
E:\FR\FM\28SEN1.SGM
28SEN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
Microbiology Branch (DCIFCF2)
Atlanta Human and Animal Food
Laboratory (DCIFCG)
Chemistry Branch (DCIFCG1)
Microbiology Branch (DCIFCG2)
Nutrient Analysis Branch (DCIFCG3)
Irvine Human and Animal Food
Laboratory (DCIFCH)
Chemistry Branch (DCIFCH1)
Microbiology Branch (DCIFCH2)
Office of Safety (DCIFD)
Office of Medical Products and Tobacco
Operations (DCIG)
Tobacco Operations Staff (DCIG1)
Office of Bioresearch Monitoring
Operations (DCIGA)
Bioresearch Monitoring Operations Staff
(DCIGA1)
Operations Staff (DCIGA2)
Bioresearch Monitoring Dedicated
Foreign Cadre Staff (DCIGA3)
Division of Bioresearch Monitoring
Operations I (DCIGAA)
Division of Bioresearch Monitoring
Operations II (DCIGAB)
Office of Pharmaceutical Quality
Operations (DCIGB)
Division of Pharmaceutical Quality
Program (DCIGBA)
Pharmaceutical Quality Initiatives
Branch (DCIGBA1)
Pharmaceutical Quality Programs
Branch (DCIGBA2)
Division of Foreign Pharmaceutical
Quality Inspections (DCIGBB)
Foreign Pharmaceutical Quality
Inspection Branch I (DCIGBB1)
Foreign Pharmaceutical Quality
Inspection Branch II (DCIGBB2)
Division of Pharmaceutical Quality
Operations I (DCIGBC)
Pharmaceutical Quality Investigations
Branch I (DCIGBC1)
Pharmaceutical Quality Investigations
Branch II (DCIGBC2)
Pharmaceutical Quality Compliance
Branch (DCIGBC3)
Division of Pharmaceutical Quality
Operations II (DCIGBD)
Pharmaceutical Quality Investigations
Branch (DCIGBD1)
Pharmaceutical Quality Compliance
Branch (DCIGBD2)
Division of Pharmaceutical Quality
Operations III (DCIGBE)
Pharmaceutical Quality Investigations
Branch (DCIGBE1)
Pharmaceutical Quality Compliance
Branch (DCIGBE2)
Division of Pharmaceutical Quality
Operations IV (DCIGBF)
Pharmaceutical Quality Investigations
Branch (DCIGBF1)
Pharmaceutical Quality Compliance
Branch (DCIGBF2)
Office of Biological Product Operations
(DCIGC)
Biological Products Operations Staff
(DCIGC1)
VerDate Sep<11>2014
18:06 Sep 27, 2022
Jkt 256001
Division of Biological Product
Operations I (DCIGCA)
Biological Products Investigations
Branch (DCIGCA1)
Biological Products Compliance Branch
(DCIGCA2)
Biological Products Inspection Staff
(DCIGCA3)
Division of Biological Product
Operations II (DCIGCB)
Biological Products Investigations
Branch (DCIGCB1)
Biological Products Compliance Branch
(DCIGCB2)
Biological Products Inspection Staff
(DCIGCB3)
Office of Medical Devices and
Radiological Health Operations
(DCIGD)
Medical Devices and Radiological
Health Operations Staff (DCIGD1)
Foreign Medical Devices and
Radiological Health Inspection Staff
(DCIGD2)
Division of Medical Devices and
Radiological Health Operations I
(DCIGDA)
Medical Devices and Radiological
Health Investigations Branch
(DCIGDA1)
Medical Devices and Radiological
Health Compliance Branch
(DCIGDA2)
Division of Medical Devices and
Radiological Health Operations II
(DCIGDB)
Medical Devices and Radiological
Health Investigations Branch
(DCIGDB1)
Medical Devices and Radiological
Health Compliance Branch
(DCIGDB2)
Division of Medical Devices and
Radiological Health Operations III
(DCIGDC)
Medical Devices and Radiological
Health Investigations Branch
(DCIGDC1)
Medical Devices and Radiological
Health Compliance Branch
(DCIGDC2)
Office of Partnerships and Operational
Policy (DCIH)
Office of Partnerships (DCIHB)
Division of Partnership Investigations
and Agreements (DCIHBA)
Human and Animal Food Branch
(DCIHBA1)
Laboratory, Medical Products, and
Innovation Branch (DCIHBA2)
Division of Integration (DCIHBB)
Division of Standards Implementation
(DCIHBC)
Division of Information Disclosure
Policy (DCIHBD)
Freedom of Information Act Branch 1
(DCIHBD1)
Freedom of Information Act Branch 2
(DCIHBD2)
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
58809
Disclosure Policy Branch (DCIHBD3)
Produce Branch (DCIHBBD4)
Office of Policy, Compliance, and
Enforcement (DCIHE)
Division of Operational Policy
(DCIHEA)
Human and Animal Food Policy Branch
(DCIHEA1)
Medical Products and Tobacco Policy
Branch (DCIHEA2)
Imports Policy Branch (DCIHEA3)
Division of Planning and Evaluation
(DCIHEB)
Division of Enforcement (DCIHEC)
Recall Operations Branch (DCIHEC1)
Health Fraud Branch (DCIHEC2)
Office of Strategic Planning and Quality
Management (DCIHF)
Strategic Planning Staff (DCIHF1)
Division of Quality Management
Systems (DCIHFA)
Office of Import Operations (DCII)
Division of Food Defense Targeting
(DCIIB)
Division of Import Operations (DCIIC)
Import Operations Branch (DCIIC1)
Import Compliance Branch (DCIIC2)
Division of Analysis and Program
Evaluation (DCIID)
Program Development Branch (DCIID1)
Import Technical Assistance Branch
(DCIID2)
Division of Southwest Imports (DCIIE)
Southwest Import Investigations Branch
(DCIIE1)
Southwest Import Compliance Branch
(DCIIE2)
Division of Southeast Imports (DCIIF)
Southeast Import Investigations Branch
I (DCIIF1)
Southeast Import Investigations Branch
II (DCIIF2)
Southeast Import Compliance Branch
(DCIIF3)
Division of Northeast Imports (DCIIG)
Northeast Import Investigations Branch
(DCIIG1)
Northeast Import Compliance Branch
(DCIIG2)
Division of Northern Border Imports
(DCIIH)
Northern Boarder Import Investigations
Branch I (DCIIH1)
Northern Boarder Import Investigations
Branch II (DCIIH2)
Northern Boarder Import Compliance
Branch (DCIIH3)
Division of West Coast Imports (DCIII)
West Coast Import Investigations Branch
(DCIII1)
West Coast Import Compliance Branch
(DCIII2)
Division of Planning and Public
Response (DCIIJ)
Office of Information Systems
Management (DCIJ)
Division of Enforcement Systems
Solutions (DCIJA)
Enforcement Systems Branch (DCIJA1)
E:\FR\FM\28SEN1.SGM
28SEN1
58810
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
Enforcement Data Management Branch
(DCIJA2)
Division of Import Systems Solutions
(DCIJB)
Import Systems Branch (DCIJB1)
Import Data Management Branch
(DCIJB2)
Division of Information Technology
Planning and Management Services
(DCIJC)
Solutions Planning Branch (DCIJC1)
Information Technology Management
and Governance Services Branch
(DCIJC2)
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.
Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s website at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
(Authority: 44 U.S.C. 3101)
Dated: September 23, 2022.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2022–20996 Filed 9–27–22; 8:45 am]
BILLING CODE P
Food and Drug Administration
[Docket No. FDA–2017–D–6569]
Clinical Decision Support Software;
Guidance for Industry and Food and
Drug Administration Staff; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Clinical Decision
Support Software.’’ This final guidance
provides clarity on FDA’s oversight of
clinical decision support (CDS) software
intended for health care professionals
with the purpose of describing FDA’s
regulatory approach to CDS software
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:06 Sep 27, 2022
Jkt 256001
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
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
functions. This guidance clarifies the
types of CDS functions that do not meet
the definition of a device as amended by
the 21st Century Cures Act (Cures Act).
DATES: The announcement of the
guidance is published in the Federal
Register on September 28, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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–
2017–D–6569] for ‘‘Clinical Decision
Support Software; Guidance for
Industry and Food and Drug
Administration Staff.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Clinical Decision
Support Software; Guidance for
Industry and Food and Drug
Administration Staff’’ to the Office of
Policy, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58807-58810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20996]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Office of Regulatory Affairs, Food and Drug Administration,
Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Headquarters (HQ) and Field Offices (RFO) have modified
its structure.
DATES: This new organizational structure was approved by the Deputy
Secretary of Health and Human Services on December 22, 2021, and became
effective on February 9, 2022.
FOR FURTHER INFORMATION CONTACT: Glenda Barfell, Associate Commissioner
for Regulatory Management Operations, Office of Regulatory Management
Operations, Office of Regulatory Affairs, Food and Drug Administration,
Element Building, Room 2002, 12420 Parklawn Drive, Rockville, MD 20857,
Phone: 240-402-7562.
SUPPLEMENTARY INFORMATION: Part D, Chapter D-B, (Food and Drug
Administration), the Statement of Organization, Functions, and
Delegations of Authority for the Department of Health and Human
Services (35 FR 3685, February 25, 1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, 74 FR 41713,
August 18, 2009, 76 FR 45270, July 28, 2011, and 84 FR 22854, May 20,
2019) is amended to reflect the reorganization of the Office of
Regulatory Affairs Headquarters Offices and Field Offices.
This reorganization is a continuation of the Program Alignment (PA)
reorganization completed in 2017 to enhance organizational efficiencies
identified after PA. The objective is to improve the Office of
Regulatory Affairs (ORA) core functions, correct and enhance the
structure with effective use of resources, and carry out the mission of
protecting consumers by ensuring compliance of FDA-regulated products.
As industry rapidly changes, the FDA must continue to evolve to ensure
that public health is not negatively impacted by gaps in inspections
and investigations of regulated firms.
The Food and Drug Administration, Office of Regulatory Affairs
(ORA), has been restructured as follows:
DCI. ORGANIZATION. The Office of Regulatory Affairs is headed by
the Associate Commissioner for Regulatory Affairs and includes the
following organizational units:
Office of Regulatory Affairs (DCI)
Office of the Associate Commissioner for Regulatory Affairs (DCIA)
Data Analytics and Program Evaluation Staff (DCIA1)
Office of Regulatory Management Operations (DCIB)
Management Liaison Staff (DCIB1)
Office of Budget, Facilities, and Travel Support (DCIBB)
Division of Financial Operations (DCIBBA)
Budget Execution Branch (DCIBBA1)
Budget Formulation Branch (DCIBBA2)
Funds Control and Policy Branch (DCIBBA3)
Work Planning Branch (DCIBBA4)
Division of Facilities and Property Management (DCIBBBB)
Laboratory Support Branch (DCIBBBB1)
Real Property Management Branch East (DCIBBB2)
Real Property Management Branch West (DCIBBB3)
Fleet and Personal Property Management Branch (DCIBBB4)
Division of Contracts and Grants (DCIBBC)
State Contracts and Agreements Branch (DCIBBC1)
Scientific Contracts and Agreements Branch (DCIBBC2)
Operational Contracts and Agreements Branch (DCIBBC3)
Division of Travel Operations (DCIBBD)
Domestic Travel Branch (DCIBBD1)
Medical Products Travel Branch (DCIBBD2)
Human and Animal Food Travel Branch (DCIBBD3)
Travel Compliance Branch (DCIBBD4)
Office of Workforce Management (DCIBC)
Executive and Scientific Recruitment Staff (DCIBC1)
Division of Human Capital Staffing Services (DCIBCA)
Talent Acquisitions Branch 1 (DCIBCA1)
Talent Acquisitions Branch 2 (DCIBCA2)
Talent Acquisitions Branch 3 (DCIBCA3)
Talent Acquisitions Branch 4 (DCIBCA4)
Talent Acquisitions Branch 5 (DCIBCA5)
Special Hiring Branch (DCIBCA6)
Classification and Reorganization Branch (DCIBCA7)
Division of Human Capital Programs (DCIBCB)
Performance Management Branch (DCIBCB1)
Employee Engagement Branch (DCIBCB2)
Management Analysis Branch (DCIBCB3)
Office of Training, Education and Development (DCIBF)
Quality and Records Management Staff (DCIBF1)
Division of Programmatic Training (DCIBFA)
Programmatic Training Branch 1 (DCIBFA1)
Programmatic Training Branch 2 (DCIBFA2)
Division of Multi-Program, Leadership and Management Training (DCIBFB)
Multi-Program Leadership and Management Branch (DCIBFB1)
Leadership, Management, and Mentoring Training Branch (DCIBFB2)
Division of Instructional Systems and Technology (DCIBFC)
Instructional Systems Branch (DCIBFC1)
Learning Management Technology and Multimedia Branch (DCIBFC2)
Division of Testing, Measurement, Certification, and Program Analysis
(DCIBFD)
Test, Measurement, and Analysis Branch (DCIBFD1)
Certification Branch (DCIBFD2)
Office of Criminal Investigations (DCIC)
Metro Washington Field Office (DCICA)
Philadelphia Resident Unit (DCICA1)
Chicago Field Office (DCICB)
New York Field Office (DCICC)
[[Page 58808]]
Boston, MA Resident Unit (DCICC1)
Los Angeles Field Office (DCICD)
San Francisco, CA Resident Unit (DCICD1)
Miami Field Office (DCICE)
San Juan, PR Resident Unit (DCICE1)
Atlanta, GA Resident Unit (DCICE2)
New Orleans, LA Resident Unit (DCICE3)
Kansas City Field Office (DCICF)
Dallas, TX Resident Unit (DCICF1)
Office of Communications and Project Management (DCID)
Executive Secretariat Staff (DCID2)
Division of Communications (DCIDA)
Public Affairs Branch (DCIDA1)
Web and Digital Media Branch (DCIDA2)
Strategic Communications Branch (DCIDA3)
Division of Project Management (DCIDB)
Project Management Resource Branch (DCIDB1)
Project Management Branch 1 (DCIDB1)
Project Management Branch 2 (DCIDB2)
Office of Human and Animal Food Operations (DCIE)
Audit Staff (DCIE1)
Office of State Cooperative Programs (DCIEA)
Division of Retail Food Protection (DCIEAA)
Retail Food Protection Branch 1 (DCIEAA1)
Retail Food Protection Branch 2 (DCIEAA2)
Retail Food Protection Branch 3 (DCIEAA3)
Division of Milk Safety (DCIEAB)
Milk Safety Branch 1 (DCIEAB1)
Milk Safety Branch 2 (DCIEAB2)
Milk Safety Branch 3 (DCIEAB3)
Division of Shellfish Sanitation (DCIEAC)
Shellfish Sanitation Branch 1 (DCIEAC1)
Shellfish Sanitation Branch 2 (DCIEAC2)
Office of Human and Animal Food Operations East (DCIEB)
Division of Foreign Human and Animal Food Operations (DCIEBA)
Foreign Human and Animal Food Inspections Branch 1 (DCIEBA)
Foreign Human and Animal Food Inspections Branch 2 (DCIEBA2)
Foreign Human and Animal Food Operations Branch (DCIEBA3)
Foreign Human and Animal Food Inspections Planning Branch (DCIEBA4)
Division of Human and Animal Food Operations East I (DCIEBB)
Human and Animal Food Investigations Branch (DCIEBB1)
Human and Animal Food Compliance Branch (DCIEBB2)
Division of Human and Animal Food Operations East II (DCIEBC)
Human and Animal Food Investigations Branch (DCIEBC1)
Human and Animal Food Compliance Branch (DCIEBC2)
Division of Human and Animal Food Operations East III (DCIEBD)
Human and Animal Food Investigations Branch (DCIEBD1)
Human and Animal Food Compliance Branch (DCIEBD2)
Division of Human and Animal Food Operations East IV (DCIEBE)
Human and Animal Food Investigations Branch (DCIEBE1)
Human and Animal Food Compliance Branch (DCIEBE2)
Division of Human and Animal Food Operations East V (DCIEBF)
Human and Animal Food Investigations Branch 1 (DCIEBF1)
Human and Animal Food Investigations Branch 2 (DCIEBF2)
Human and Animal Food Compliance Branch (DCIEBF3)
Division of Human and Animal Food Operations East VI (DCIEBG)
Human and Animal Food Investigations Branch (DCIEBG1)
Human and Animal Food Compliance Branch (DCIEBG2)
Office of Human and Animal Food Operations West (DCIEC)
Division of Domestic Human and Animal Food Operations (DCIECA)
Domestic Human and Animal Food Operations Branch (DCIECA1)
Domestic Produce Safety Branch 1 (DCIECA2)
Domestic Produce Safety Branch 2 (DCIECA3)
Division of Human and Animal Food Operations West I (DCIECB)
Human and Animal Food Investigations Branch (DCIECB1)
Human and Animal Food Compliance Branch (DCIECB2)
Division of Human and Animal Food Operations West II (DCIECC)
Human and Animal Food Investigations Branch (DCIECC1)
Human and Animal Food Compliance Branch (DCIECC2)
Division of Human and Animal Food Operations West III (DCIECD)
Human and Animal Food Investigations Branch (DCIECD1)
Human and Animal Food Compliance Branch (DCIECD2)
Division of Human and Animal Food Operations West IV (DCIECE)
Human and Animal Food Investigations Branch (DCIECE1)
Human and Animal Food Compliance Branch (DCIECE2)
Division of Human and Animal Food Operations West V (DCIECF)
Human and Animal Food Investigations Branch 1 (DCIECF1)
Human and Animal Food Investigations Branch 2 (DCIECF2)
Human and Animal Food Compliance Branch (DCIECF3)
Division of Human and Animal Food Operations West VI (DCIECG)
Human and Animal Food Investigations Branch (DCIECG1)
Human and Animal Food Compliance Branch (DCIECG2)
Office of Regulatory Science (DCIF)
Informatics and Business Operations Staff (DCIF1)
Office of Research, Coordination, Evaluation, and Training (DCIFA)
Scientific Research Staff (DCIFA1)
Evaluation Staff (DCIFA2)
Office of Medical Products and Specialty Laboratory Operations (DCIFB)
Medical Products and Tobacco Scientific Staff (DCIFB1)
Forensic Chemistry Center (DCIFBA)
Inorganic Branch (DCIFBA1)
Organic Branch (DCIFBA2)
Satellite Laboratory Branch (DCIFBA3)
Winchester Engineering and Analytical Center (DCIFBB)
Analytical Branch (DCIFBB1)
Engineering Branch (DCIFBB2)
Detroit Medical Products Laboratory (DCIFBC)
New York Medical Products Laboratory (DCIFBD)
Irvine Medical Products Laboratory (DCIFBE)
Philadelphia Medical Products Laboratory (DCIFBF)
San Juan Medical Products Laboratory (DCIFBG)
Tobacco Products Laboratory (DCIFBH)
Office of Human and Animal Foods Laboratory Operations (DCIFC)
Human and Animal Food Scientific Staff (DCIFC1)
Arkansas Human and Animal Food Laboratory (DCIFCA)
Chemistry Branch 1 (DCIFCA1)
Chemistry Branch 2 (DCIFCA2)
Microbiology Branch (DCIFCA3)
Denver Human and Animal Food Laboratory (DCIFCB)
Chemistry Branch (DCIFCB1)
Microbiology Branch (DCIFCB2)
Kansas City Human and Animal Food Laboratory (DCIFCC)
Chemistry Branch 1 (DCIFCC1)
Chemistry Branch 2 (DCIFCC2)
New York Human and Animal Food Laboratory (DCIFCD)
Chemistry Branch (DCIFCD1)
Microbiological Sciences Branch (DCIFCD2)
Seattle Human and Animal Food Laboratory (DCIFCE)
Chemistry Branch (DCIFCE1)
Microbiology Branch (DCIFCE2)
Applied Technology Branch (DCIFCE3)
San Francisco Human and Animal Food Laboratory (DCIFCF)
Chemistry Branch (DCIFCF1)
[[Page 58809]]
Microbiology Branch (DCIFCF2)
Atlanta Human and Animal Food Laboratory (DCIFCG)
Chemistry Branch (DCIFCG1)
Microbiology Branch (DCIFCG2)
Nutrient Analysis Branch (DCIFCG3)
Irvine Human and Animal Food Laboratory (DCIFCH)
Chemistry Branch (DCIFCH1)
Microbiology Branch (DCIFCH2)
Office of Safety (DCIFD)
Office of Medical Products and Tobacco Operations (DCIG)
Tobacco Operations Staff (DCIG1)
Office of Bioresearch Monitoring Operations (DCIGA)
Bioresearch Monitoring Operations Staff (DCIGA1)
Operations Staff (DCIGA2)
Bioresearch Monitoring Dedicated Foreign Cadre Staff (DCIGA3)
Division of Bioresearch Monitoring Operations I (DCIGAA)
Division of Bioresearch Monitoring Operations II (DCIGAB)
Office of Pharmaceutical Quality Operations (DCIGB)
Division of Pharmaceutical Quality Program (DCIGBA)
Pharmaceutical Quality Initiatives Branch (DCIGBA1)
Pharmaceutical Quality Programs Branch (DCIGBA2)
Division of Foreign Pharmaceutical Quality Inspections (DCIGBB)
Foreign Pharmaceutical Quality Inspection Branch I (DCIGBB1)
Foreign Pharmaceutical Quality Inspection Branch II (DCIGBB2)
Division of Pharmaceutical Quality Operations I (DCIGBC)
Pharmaceutical Quality Investigations Branch I (DCIGBC1)
Pharmaceutical Quality Investigations Branch II (DCIGBC2)
Pharmaceutical Quality Compliance Branch (DCIGBC3)
Division of Pharmaceutical Quality Operations II (DCIGBD)
Pharmaceutical Quality Investigations Branch (DCIGBD1)
Pharmaceutical Quality Compliance Branch (DCIGBD2)
Division of Pharmaceutical Quality Operations III (DCIGBE)
Pharmaceutical Quality Investigations Branch (DCIGBE1)
Pharmaceutical Quality Compliance Branch (DCIGBE2)
Division of Pharmaceutical Quality Operations IV (DCIGBF)
Pharmaceutical Quality Investigations Branch (DCIGBF1)
Pharmaceutical Quality Compliance Branch (DCIGBF2)
Office of Biological Product Operations (DCIGC)
Biological Products Operations Staff (DCIGC1)
Division of Biological Product Operations I (DCIGCA)
Biological Products Investigations Branch (DCIGCA1)
Biological Products Compliance Branch (DCIGCA2)
Biological Products Inspection Staff (DCIGCA3)
Division of Biological Product Operations II (DCIGCB)
Biological Products Investigations Branch (DCIGCB1)
Biological Products Compliance Branch (DCIGCB2)
Biological Products Inspection Staff (DCIGCB3)
Office of Medical Devices and Radiological Health Operations (DCIGD)
Medical Devices and Radiological Health Operations Staff (DCIGD1)
Foreign Medical Devices and Radiological Health Inspection Staff
(DCIGD2)
Division of Medical Devices and Radiological Health Operations I
(DCIGDA)
Medical Devices and Radiological Health Investigations Branch (DCIGDA1)
Medical Devices and Radiological Health Compliance Branch (DCIGDA2)
Division of Medical Devices and Radiological Health Operations II
(DCIGDB)
Medical Devices and Radiological Health Investigations Branch (DCIGDB1)
Medical Devices and Radiological Health Compliance Branch (DCIGDB2)
Division of Medical Devices and Radiological Health Operations III
(DCIGDC)
Medical Devices and Radiological Health Investigations Branch (DCIGDC1)
Medical Devices and Radiological Health Compliance Branch (DCIGDC2)
Office of Partnerships and Operational Policy (DCIH)
Office of Partnerships (DCIHB)
Division of Partnership Investigations and Agreements (DCIHBA)
Human and Animal Food Branch (DCIHBA1)
Laboratory, Medical Products, and Innovation Branch (DCIHBA2)
Division of Integration (DCIHBB)
Division of Standards Implementation (DCIHBC)
Division of Information Disclosure Policy (DCIHBD)
Freedom of Information Act Branch 1 (DCIHBD1)
Freedom of Information Act Branch 2 (DCIHBD2)
Disclosure Policy Branch (DCIHBD3)
Produce Branch (DCIHBBD4)
Office of Policy, Compliance, and Enforcement (DCIHE)
Division of Operational Policy (DCIHEA)
Human and Animal Food Policy Branch (DCIHEA1)
Medical Products and Tobacco Policy Branch (DCIHEA2)
Imports Policy Branch (DCIHEA3)
Division of Planning and Evaluation (DCIHEB)
Division of Enforcement (DCIHEC)
Recall Operations Branch (DCIHEC1)
Health Fraud Branch (DCIHEC2)
Office of Strategic Planning and Quality Management (DCIHF)
Strategic Planning Staff (DCIHF1)
Division of Quality Management Systems (DCIHFA)
Office of Import Operations (DCII)
Division of Food Defense Targeting (DCIIB)
Division of Import Operations (DCIIC)
Import Operations Branch (DCIIC1)
Import Compliance Branch (DCIIC2)
Division of Analysis and Program Evaluation (DCIID)
Program Development Branch (DCIID1)
Import Technical Assistance Branch (DCIID2)
Division of Southwest Imports (DCIIE)
Southwest Import Investigations Branch (DCIIE1)
Southwest Import Compliance Branch (DCIIE2)
Division of Southeast Imports (DCIIF)
Southeast Import Investigations Branch I (DCIIF1)
Southeast Import Investigations Branch II (DCIIF2)
Southeast Import Compliance Branch (DCIIF3)
Division of Northeast Imports (DCIIG)
Northeast Import Investigations Branch (DCIIG1)
Northeast Import Compliance Branch (DCIIG2)
Division of Northern Border Imports (DCIIH)
Northern Boarder Import Investigations Branch I (DCIIH1)
Northern Boarder Import Investigations Branch II (DCIIH2)
Northern Boarder Import Compliance Branch (DCIIH3)
Division of West Coast Imports (DCIII)
West Coast Import Investigations Branch (DCIII1)
West Coast Import Compliance Branch (DCIII2)
Division of Planning and Public Response (DCIIJ)
Office of Information Systems Management (DCIJ)
Division of Enforcement Systems Solutions (DCIJA)
Enforcement Systems Branch (DCIJA1)
[[Page 58810]]
Enforcement Data Management Branch (DCIJA2)
Division of Import Systems Solutions (DCIJB)
Import Systems Branch (DCIJB1)
Import Data Management Branch (DCIJB2)
Division of Information Technology Planning and Management Services
(DCIJC)
Solutions Planning Branch (DCIJC1)
Information Technology Management and Governance Services Branch
(DCIJC2)
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.
Electronic Access
This reorganization is reflected in FDA's Staff Manual Guide (SMG).
Persons interested in seeing the complete Staff Manual Guide can find
it on FDA's website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
(Authority: 44 U.S.C. 3101)
Dated: September 23, 2022.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2022-20996 Filed 9-27-22; 8:45 am]
BILLING CODE P
