Statement of Organization, Functions, and Delegations of Authority, 91769-91770 [2024-27011]
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
1. Agency for Toxic Substances and Disease
Registry, ‘‘Toxicological Profile for
Perfluoroalkyls.’’ Accessed June 14,
2024. Available at: https://
www.atsdr.cdc.gov/toxprofiles/
tp200.pdf.
2. U.S. Environmental Protection Agency,
‘‘Human Health Toxicity Assessment for
PFBS.’’ Accessed June 14, 2024.
Available at: https://www.epa.gov/
chemical-research/learn-about-humanhealth-toxicity-assessment-pfbs.
3. U.S. Environmental Protection Agency,
‘‘Human Health Toxicity Assessments
for GenX Chemicals.’’ Accessed June 14,
2024. Available at: https://www.epa.gov/
chemical-research/human-healthtoxicity-assessments-genx-chemicals.
4. U.S. Environmental Protection Agency,
‘‘Final IRIS Assessment of
Perfluorobutanoic Acid (PFBA) and
Related Salts.’’ Accessed June 14, 2024.
Available at: https://www.epa.gov/
newsreleases/epa-publishes-irishandbook-and-final-iris-assessmentperfluorobutanoic-acid-pfba-and.
5. U.S. Food and Drug Administration,
‘‘Testing Food for PFAS and Assessing
Dietary Exposure.’’ Accessed June 14,
2024. Available at: https://www.fda.gov/
food/process-contaminants-food/testingfood-pfas-and-assessing-dietaryexposure.
6. U.S. Food and Drug Administration,
‘‘Analytical Results of Testing Food for
PFAS from Environmental
Contamination.’’ Accessed June 14, 2024.
Available at: https://www.fda.gov/food/
process-contaminants-food/analyticalresults-testing-food-pfas-environmentalcontamination.
7. U.S. Food and Drug Administration,
‘‘Activities for the Safety of Imported
Seafood, February 2023.’’ Accessed June
14, 2024. Available at: https://
www.fda.gov/media/165447/download.
8. U.S. Food and Drug Administration, ‘‘FDA
Shares Results on PFAS Testing in
Seafood, July 15, 2022.’’ Accessed June
14, 2024. Available at: https://
www.fda.gov/food/cfsan-constituentupdates/fda-shares-results-pfas-testingseafood.
9. U.S. Food and Drug Administration,
‘‘Crown Prince, Inc. Issues Voluntary
Recall of Smoked Baby Clams in Olive
Oil Due to the Presence of Detectable
Levels of PFAS Chemicals.’’ Accessed
June 14, 2024. Available at: https://
www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/crown-princeinc-issues-voluntary-recall-smoked-babyclams-olive-oil-due-presence-detectablelevels.
10. The White House, ‘‘Fact Sheet: BidenHarris Administration Launches Plan to
Combat PFAS Pollution, October 2021.’’
Accessed June 14, 2024. Available at:
https://www.whitehouse.gov/briefingroom/statements-releases/2021/10/18/
fact-sheet-biden-harris-administrationlaunches-plan-to-combat-pfas-pollution/
.
11. The White House, ‘‘Fact Sheet: BidenHarris Administration Combatting PFAS
Pollution to Safeguard Clean Drinking
VerDate Sep<11>2014
18:39 Nov 19, 2024
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Water for All Americans, June 2022.’’
Accessed June 14, 2024. Available at:
https://www.whitehouse.gov/briefingroom/statements-releases/2022/06/15/
fact-sheet-biden-harris-administrationcombatting-pfas-pollution-to-safeguardclean-drinking-water-for-all-americans/.
12. The White House, ‘‘Fact Sheet: BidenHarris Administration Takes New Action
to Protect Communities from PFAS
Pollution, March 2023.’’ Accessed June
14, 2024. Available at: https://
www.whitehouse.gov/briefing-room/
statements-releases/2023/03/14/factsheet-biden-harris-administration-takesnew-action-to-protect-communities-frompfas-pollution/.
13. U.S. Food and Drug Administration,
‘‘CPG Sec. 560.200 Country of Origin
Labeling.’’ Accessed June 14, 2024.
Available at: https://www.fda.gov/media/
71994/download.
Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27070 Filed 11–19–24; 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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA), Office of the
Commissioner (OC), Office of Digital
Transformation (ODT) has modified
their organizational structure. The new
organizational structure was approved
by the Secretary of Health and Human
Services on September 20, 2024.
FOR FURTHER INFORMATION CONTACT:
William Tootle, Director, Office of
Budget; 10903 New Hampshire Avenue,
WO–2, #3313, Silver Spring, MD 20990.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
revised to reflect FDA, OC’s ODT.
The changes to ODT’s organizational
structure consolidate similar functions
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91769
and resources across multiple areas and
align the organizational structure with
federal and industry standards. This
will create a more agile organization,
improve resource management, enhance
customer service, and better align the
name of organizational components
with current functions. The
reorganization will maintain a
reasonable span of control and clear and
appropriate lines of authority and
responsibilities between organizations.
This will also ensure optimal resource
utilization and leveraging of existing
staff talent and will allow ODT more
efficiency and effectiveness in the
advancement of continuous
improvement efforts.
DCAD. ORGANIZATION: ODT is
headed by the Chief Information Officer
and includes:
Office of Digital Transformation (DCAD)
Office of Information Management and
Technology (DCADA)
Enterprise Architecture Staff (DCADA2)
Office of Technology and Delivery
(DCADAA)
Division of Infrastructure Services
(DCADAAA)
Network Services Support Staff
(DCADAAA10)
Systems Operations Support Staff
(DCADAAA11)
Operations and Planning Staff
(DCADAAA12)
Data Center Facilities Branch
(DCADAAA13)
Quality Assurance Branch (DCADAAA14)
Network Communications Branch
(DCADAAA15)
Server Operations Services Branch
(DCADAAA16)
Enterprise Management Operations Branch
(DCADAAA17)
Cloud Operations Branch (DCADAAA18)
Division of Application Services
(DCADAAB)
Operations Support Staff (DCADAAB10)
Enterprise Business and Post-Market Staff
(DCADAAB11)
Scientific Support Staff (DCADAAB12)
Human Food Support Branch
(DCADAAB13)
Regulatory Science Support Branch
(DCADAAB14)
Compliance and Enforcement Branch
(DCADAAB15)
Application Services Support Branch
(DCADAAB16)
Platform Management Support Branch
(DCADAAB17)
Digital Solutions Partners Branch
(DCADAAB18)
Business Intelligence Data Branch
(DCADAAB19)
Products Review and Approval Branch
(DCADAAB20)
Digital Solution Delivery Branch
(DCADAAB21)
Registration Listing Services Branch
(DCADAAB22)
User Fee Support Branch (DCADAAB23)
Division of Engineering (DCADAAD)
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
Engineering Services Support Staff
(DCADAAD1)
Implementation Branch (DCADAAD2)
Engineering Branch (DCADAAD3)
Data Governance Branch (DCADAAD4)
Cloud Services Branch (DCADAAD5)
Infrastructure Engineering Branch
(DCADAAD6)
Database and Content Services Branch
(DCADAAD7)
Division of Technology Quality
Management (DCADAAE)
Contract Budget and IT Strategy Branch
(DCADAAE1)
Project and Program Portfolio Branch
(DCADAAE2)
Resources Management Branch
(DCADAAE3)
Office of Customer Experience (DCADAB)
Division of Collaboration Services
(DCADABH)
Collaboration Support Branch
(DCADABH1)
Collaboration Administration Branch
(DCADABH2)
Collaboration System Administration
Branch (DCADABH3)
Division of Endpoint Management
(DCADABI)
Property and Deployment Branch
(DCADABI1)
Endpoint Management Branch
(DCADABI2)
Division of Service Desk and Support
(DCADABJ)
Service Desk Operations Branch
(DCADABJ1)
Service Management Branch (DCADABJ2)
Specialized Support Branch (DCADABJ3)
Global Support Branch (DCADABJ4)
Division of End User Services (DCADABK)
Operations Support Branch Zone 1
(DCADABK1)
Operations Support Branch Zone 2
(DCADABK2)
Operations Support Branch Zone 3
(DCADABK3)
Division of ERIC Administration
(DCADABL)
Performance, Growth and Enablement
Branch (DCADABL1)
Help Desk Service Branch (DCADABL2)
Operations and Desk Services Branch
(DCADABL3)
Office of Information Security (DCADB)
Cybersecurity Program Staff (DCADB2)
Division of Counterintelligence and Insider
Threat (DCADBE)
Counterintelligence/Cyber Hunt Branch
(DCADBE1)
Division of Cybersecurity Operations
(DCADBF)
Division of Cybersecurity Risk and
Compliance (DCADBG)
Division of Cybersecurity Capabilities and
Integrations (DCADBH)
Office of Data, Analytics, and Research
(DCADC)
Advanced Data Analytics and Innovation
Staff (DCADC1)
Data & Analytics Governance Staff
(DCADC2)
Master Data Management Staff (DCADC6)
Data Ecosystem Services Staff (DCADC7)
Data and Insights Services Staff (DCADC8)
Office of Enterprise Portfolio Management
VerDate Sep<11>2014
18:39 Nov 19, 2024
Jkt 265001
(DCADF)
Division of Acquisition Innovation
(DCADFA)
Acquisition Operations Branch
(DCADFA1)
Acquisition Governance Branch
(DCADFA2)
IT Asset Management Branch (DCADFA3)
Division of Technology Business
Management (DCADFB)
IT Governance Staff (DCADFB1)
IT Policy Branch (DCADFB2)
Business Intelligence Branch (DCADFB3)
Division of IT Finance (DCADFC)
Budget Formulation Branch (DCADFC1)
Budget Execution Branch (DCADFC2)
Office of Organizational Excellence (DCADG)
Division of Management (DCADGA)
Administrative Services Branch
(DCADGA1)
Employee Experience Branch (DCADGA2)
Talent Strategy Branch (DCADGA3)
Division of Strategy, Education, and
Communications (DCADGB)
Learning and Development Branch
(DCADGB1)
Strategic Initiatives Branch (DCADGB2)
Strategic Communications Branch
(DCADGB3)
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 SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/Staff
ManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Dated: November 14, 2024.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2024–27011 Filed 11–19–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–2515]
Determination That FORTESTA
(Testosterone) Gel, 10 Milligrams/0.5
Gram Actuation, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that FORTESTA
(testosterone) gel, 10 milligrams (mg)/
0.5 gram (gm) actuation, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Swati Rawani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221,
Silver Spring, MD 20993–0002, 240–
402–9917, Swati.Rawani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
SUMMARY:
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91769-91770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27011]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA), Office of the
Commissioner (OC), Office of Digital Transformation (ODT) has modified
their organizational structure. The new organizational structure was
approved by the Secretary of Health and Human Services on September 20,
2024.
FOR FURTHER INFORMATION CONTACT: William Tootle, Director, Office of
Budget; 10903 New Hampshire Avenue, WO-2, #3313, Silver Spring, MD
20990.
SUPPLEMENTARY INFORMATION:
I. Introduction
Part D, Chapter D-B, (Food and Drug Administration), the Statement
of Organization, Functions and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970,
60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28,
2011, and 84 FR 22854, May 20, 2019) is revised to reflect FDA, OC's
ODT.
The changes to ODT's organizational structure consolidate similar
functions and resources across multiple areas and align the
organizational structure with federal and industry standards. This will
create a more agile organization, improve resource management, enhance
customer service, and better align the name of organizational
components with current functions. The reorganization will maintain a
reasonable span of control and clear and appropriate lines of authority
and responsibilities between organizations. This will also ensure
optimal resource utilization and leveraging of existing staff talent
and will allow ODT more efficiency and effectiveness in the advancement
of continuous improvement efforts.
DCAD. ORGANIZATION: ODT is headed by the Chief Information Officer
and includes:
Office of Digital Transformation (DCAD)
Office of Information Management and Technology (DCADA)
Enterprise Architecture Staff (DCADA2)
Office of Technology and Delivery (DCADAA)
Division of Infrastructure Services (DCADAAA)
Network Services Support Staff (DCADAAA10)
Systems Operations Support Staff (DCADAAA11)
Operations and Planning Staff (DCADAAA12)
Data Center Facilities Branch (DCADAAA13)
Quality Assurance Branch (DCADAAA14)
Network Communications Branch (DCADAAA15)
Server Operations Services Branch (DCADAAA16)
Enterprise Management Operations Branch (DCADAAA17)
Cloud Operations Branch (DCADAAA18)
Division of Application Services (DCADAAB)
Operations Support Staff (DCADAAB10)
Enterprise Business and Post-Market Staff (DCADAAB11)
Scientific Support Staff (DCADAAB12)
Human Food Support Branch (DCADAAB13)
Regulatory Science Support Branch (DCADAAB14)
Compliance and Enforcement Branch (DCADAAB15)
Application Services Support Branch (DCADAAB16)
Platform Management Support Branch (DCADAAB17)
Digital Solutions Partners Branch (DCADAAB18)
Business Intelligence Data Branch (DCADAAB19)
Products Review and Approval Branch (DCADAAB20)
Digital Solution Delivery Branch (DCADAAB21)
Registration Listing Services Branch (DCADAAB22)
User Fee Support Branch (DCADAAB23)
Division of Engineering (DCADAAD)
[[Page 91770]]
Engineering Services Support Staff (DCADAAD1)
Implementation Branch (DCADAAD2)
Engineering Branch (DCADAAD3)
Data Governance Branch (DCADAAD4)
Cloud Services Branch (DCADAAD5)
Infrastructure Engineering Branch (DCADAAD6)
Database and Content Services Branch (DCADAAD7)
Division of Technology Quality Management (DCADAAE)
Contract Budget and IT Strategy Branch (DCADAAE1)
Project and Program Portfolio Branch (DCADAAE2)
Resources Management Branch (DCADAAE3)
Office of Customer Experience (DCADAB)
Division of Collaboration Services (DCADABH)
Collaboration Support Branch (DCADABH1)
Collaboration Administration Branch (DCADABH2)
Collaboration System Administration Branch (DCADABH3)
Division of Endpoint Management (DCADABI)
Property and Deployment Branch (DCADABI1)
Endpoint Management Branch (DCADABI2)
Division of Service Desk and Support (DCADABJ)
Service Desk Operations Branch (DCADABJ1)
Service Management Branch (DCADABJ2)
Specialized Support Branch (DCADABJ3)
Global Support Branch (DCADABJ4)
Division of End User Services (DCADABK)
Operations Support Branch Zone 1 (DCADABK1)
Operations Support Branch Zone 2 (DCADABK2)
Operations Support Branch Zone 3 (DCADABK3)
Division of ERIC Administration (DCADABL)
Performance, Growth and Enablement Branch (DCADABL1)
Help Desk Service Branch (DCADABL2)
Operations and Desk Services Branch (DCADABL3)
Office of Information Security (DCADB)
Cybersecurity Program Staff (DCADB2)
Division of Counterintelligence and Insider Threat (DCADBE)
Counterintelligence/Cyber Hunt Branch (DCADBE1)
Division of Cybersecurity Operations (DCADBF)
Division of Cybersecurity Risk and Compliance (DCADBG)
Division of Cybersecurity Capabilities and Integrations (DCADBH)
Office of Data, Analytics, and Research (DCADC)
Advanced Data Analytics and Innovation Staff (DCADC1)
Data & Analytics Governance Staff (DCADC2)
Master Data Management Staff (DCADC6)
Data Ecosystem Services Staff (DCADC7)
Data and Insights Services Staff (DCADC8)
Office of Enterprise Portfolio Management (DCADF)
Division of Acquisition Innovation (DCADFA)
Acquisition Operations Branch (DCADFA1)
Acquisition Governance Branch (DCADFA2)
IT Asset Management Branch (DCADFA3)
Division of Technology Business Management (DCADFB)
IT Governance Staff (DCADFB1)
IT Policy Branch (DCADFB2)
Business Intelligence Branch (DCADFB3)
Division of IT Finance (DCADFC)
Budget Formulation Branch (DCADFC1)
Budget Execution Branch (DCADFC2)
Office of Organizational Excellence (DCADG)
Division of Management (DCADGA)
Administrative Services Branch (DCADGA1)
Employee Experience Branch (DCADGA2)
Talent Strategy Branch (DCADGA3)
Division of Strategy, Education, and Communications (DCADGB)
Learning and Development Branch (DCADGB1)
Strategic Initiatives Branch (DCADGB2)
Strategic Communications Branch (DCADGB3)
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 SMG can find it on FDA's
website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Dated: November 14, 2024.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-27011 Filed 11-19-24; 8:45 am]
BILLING CODE 4164-01-P
