Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices 11837 

Investigational Drugs Under an IND: 

Questions and Answers.’’ FDA issued a 

revised draft guidance of the same title 

in August 2022 to include responses to 

stakeholder questions received since 

publication of the final guidance in 

2016. This guidance finalizes the 

revised draft guidance issued on August 

23, 2022 (87 FR 51679). FDA considered 

comments received on the revised draft 

guidance as the guidance was finalized. 

Changes from the revised draft to the 

final guidance address the inclusion of 

information about charging for 

investigational drugs in the informed 

consent document and provide the 

definition of intermediate-size patient 

population expanded access. In 

addition, editorial changes were made 

to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Charging for 

Investigational Drugs Under an IND: 

Questions and Answers.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: February 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03186 Filed 2–14–24; 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 December 21, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Yashika Rahaman, Director, Office of 

Planning, Evaluation and Risk 

Management; Office of Finance, Budget, 

Acquisitions, and Planning; 4041 

Powder Mill Road, Beltsville, MD 

20705–4304; 301–796–3843. 

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 the FDA, OC’s ODT. 

The proposed 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. 

This reorganization elevates the 

functions and resources of the Office of 

Enterprise Portfolio Management in the 

Office of Information Management and 

Technology (OIMT) to the Office of 

Digital Transformation; established the 

Division of Acquisition Innovation, 

Division of Technology Business 

Management, and the Division of 

Finance and Budget within OEPM; and 

realigned the Delivery Management 

Support Staff from the Office of 

Technology and Delivery (OTD) to 

OEPM, Division of Acquisition 

Innovation; established the Acquisitions 

Operations Branch, Acquisition 

Governance Branch, and IT Asset 

Management Branch within the Division 

of Acquisition Innovation; established 

the IT Governance Branch and Business 

Intelligence Branch within the Division 

of Technology Business Management; 

establish the Budget Formulation 

Branch and Budget Execution Branch 

within the Division of Finance and 

Budget; established the Office of 

Organizational Excellence (OEX) 

reporting to the ODT; established the 

Division of People and Culture (DPC) 

and the Division of Knowledge and 

Communications (DKC) within OEX; 

realigned the staff resources and 

functions from the OBCA Division of 

Management Services (DMS) to DPC in 

OEX; established the Talent Strategy 

Staff (TSS) and the Executive Services 

Staff (ESS) within OEX; abolished the 

Strategic Operations Staff (SOS) located 

in ODT Immediate Office and realigned 

staff resources and functions to DKC in 

OEX; realigned staff resources and 

functions from the Knowledge 

Management Staff (KMS) in the Office of 

Data, Analytics, and Research to DKC; 

realigned existing executive services 

functions and staff in the ODAR, OIMT, 

and ODT immediate offices to DKC; 

retitled the current Office of Business 

and Customer Assurance in OIMT to the 

Office of Customer Experience (OCX); 

abolished the Division of Management 

Services and Division of Business 

Partnerships and Support in the current 

Office of Business and Customer 

Assurance; established the Division of 

Collaboration Services, Division of 

Service Desk and Support, Division of 

Endpoint Management, Division of End 

User Services, and Division of Employee 

Information in the new OCX; 

established the Enterprise Architecture 

Staff in the OIMT Immediate Office; 

established the Division of Engineering 

(DE) in the OIMT Office of Technology 

and Delivery; established the 

Engineering Branch, Implementation 

Branch, Application Branch, and 

Database & Content Services Branch 

within DE; retitled the Division of 

Infrastructure Operations (DIO) in the 

OTD in OIMT to the Division of 

Infrastructure Services (DIS); abolished 

the Infrastructure Management Services 

Staff (IMSS) within DIO and realigned 


khammond on DSKJM1Z7X2PROD with NOTICES
11838 Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices 

the staff resources and functions to the 

DIS immediate office; abolished the 

DIO’s Implementation Branch, 

Infrastructure Engineering Branch, 

System Operations Branch, Network 

and Communications Operations 

Branch, Systems Monitoring and 

Response Branch, and Systems 

Monitoring and Response Branch; 

established the Network Services 

Branch, Systems Services Branch, and 

Operations Branch in DIS; realigned 

staff resources based on their roles and 

responsibilities; abolished the Delivery 

Management Support Staff (DMSS) 

within OTD immediate office; abolished 

the Application Management Services 

Staff, Medical Products Branch, OC/ 

CVM/CTP Branch, ORA/CFSAN/CVM 

Branch, Enterprise Applications Branch, 

Data Management and Operations 

Branch within OIMT/OTD/Division of 

Application Services (DAS); established 

the Regulatory Operations Branch, 

Scientific Operations Branch, and 

Business & Post-Market Branch within 

DAS; retitled the Office of Data, 

Analytics, and Research (ODAR), Data 

Staff to the Analytics Staff; retitled the 

ODAR Health Informatics Staff to the 

Informatics Staff; established the Data 

and Analytics Governance Staff and 

Data Strategy and Services Staff within 

ODAR; abolished the Knowledge 

Management Staff (KMS) within ODAR 

and realigned the staff resources and 

functions to the Office of Organizational 

Excellence, Division of Knowledge & 

Communications; established the 

Division of Cybersecurity Capabilities 

(DCC), Division of Risk & Compliance 

(DRC), Division of Cybersecurity 

Operations (DCO), and the Division of 

Counterintelligence & Insider Threat 

(DCIT) within the Office of Information 

Security (OIS); established the 

Vulnerability Management Branch and 

Identity Management Branch under 

OIS/DCC; established the Information 

System Security Branch and Risk 

Compliance and Audit Branch under 

OIS/DRMC; established the CIOCC 

Operations Branch and Network 

Security Branch under OIS/DCO; 

established the Program Staff within the 

OIS immediate office; realigned OIS 

staff resources and functions within OIS 

based on their roles and responsibilities. 

The Food and Drug Administration 

Office of the Commissioner’s Office of 

Digital Transformation is headed by the 

Chief Information Officer and has been 

restructured as follows: 

Office of Digital Transformation (DCAD) 

Office of Information Management and 

Technology (DCADA) 

Enterprise Architecture Staff (DCADA1) 

Office of Technology and Delivery 

(DCADAA) 

Division of Infrastructure Services 

(DCADAAA) 

Network Services Branch (DCADAAA1) 

Systems Services Branch (DCADAAA2) 

Operations Branch (DCADAAA3) 

Division of Application Services 

(DCADAAB) 

Regulatory Operations Branch 

(DCADAAB1) 

Scientific Operations Branch 

(DCADAAB2) 

Business and Post-Market Branch 

(DCADAAB3) 

Division of Engineering (DCADAAC) 

Engineering Branch (DCADAAC1) 

Implementation Branch (DCADAAC2) 

Application Branch (DCADAAC3) 

Database & Content Services Branch 

(DCADAAC4) 

Office of Customer Experience 

(DCADAB) 

Division of Collaboration Services 

(DCADABA) 

Division of Service Desk and Support 

(DCADABB) 

Division of Endpoint Management 

(DCADABC) 

Division of End User Services 

(DCADABD) 

Division of Employee Information 

(DCADABE) 

Office of Information Security (DCADB) 

Program Staff (DCADB1) 

Division of Cybersecurity Capabilities 

(DCADBA) 

Vulnerability Management Branch 

(DCADBA1) 

Identity Management Branch 

(DCADBA2) 

Division of Risk and Compliance 

(DCADBB) 

Information System Security Branch 

(DCADBB1) 

Risk Compliance and Audit Branch 

(DCADBB2) 

Division of Cybersecurity Operations 

(DCADBC) 

CIOCC Operations Branch (DCADBC1) 

Network Security Branch (DCADBC2) 

Division of Counterintelligence/Insider 

Threat (DCADBD) 

Office of Data, Analytics, and Research 

(DCADC) 

Analytics Staff (DCADC1) 

Informatics Staff (DCADC2) 

Data and Analytics Governance Staff 

(DCADC4) 

Data Strategy and Services Staff 

(DCADC5) 

Office of Enterprise Portfolio 

Management (DCADD) 

Division of Acquisition Innovation 

(DCADDA) 

Acquisitions Operations Branch 

(DCADDA1) 

Acquisitions Governance Branch 

(DCADDA2) 

IT Asset Management Branch 

(DCADDA3) 

Division of Technology Business 

Management (DCADDB) 

IT Governance Branch (DCADDB1) 

Business Intelligence Branch 

(DCADDB2) 

Division of Finance and Budget 

(DCADDC) 

Budget Formulation Branch (DCADDC1) 

Budget Execution Branch (DCADDC2) 

Office of Organizational Excellence 

(DCADE) 

Talent Strategy Staff (DCADE1) 

Executive Services Staff (DCADE2) 

Division of People and Culture 

(DCADEA) 

Employee Experience Branch 

(DCADEA1) 

Learning and Development Branch 

(DCADEA2) 

Division of Knowledge and 

Communications (DCADEB) 

Knowledge and Innovation Branch 

(DCADEB1) 

Communications and Outreach Branch 

(DCADEB2) 

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. 

Xavier Becerra, 

Secretary of Health and Human Services. 

[FR Doc. 2024–02603 Filed 2–14–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; DATA 2000 Waiver Training 

Payment Program Application for 

Payment, OMB No. 0906–0061 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 


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