Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91769 

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 

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. 

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) 


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91770 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 

(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 

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. 

SUMMARY: 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 


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