Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 107149 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, an additional non-voting 

representative member of consumer 

interests and an additional non-voting 

representative member of industry 

interests will be included in addition to 

the voting members. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

dermatologic-and-ophthalmic-drugsadvisory-committee/dermatologic-andophthalmic-drugs-advisory-committeecharter or by contacting the Designated 

Federal Officer (see FOR FURTHER

INFORMATION CONTACT). In light of the 

fact that no change has been made to the 

committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act as 

amended (5 U.S.C. 1001 et seq.). For 

general information related to FDA 

advisory committees, please visit us at 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31363 Filed 12–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Advanced Research Projects 

Agency for Health, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This document announces 

that the Establishment of the Advanced 

Research Projects Agency for Health 

(ARPA–H) is being amended to reflect a 

revised organizational structure for 

ARPA–H that aligns with current 

statutory requirements. See 42 U.S.C. 

290c(a)(2). 

SUPPLEMENTARY INFORMATION: The 

Establishment of the Advanced 

Research Projects Agency for Health 

(ARPA–H) (May 24, 2022, at 87 FR 

32174) should now read as follows: 

Section I. Mission 

The mission of ARPA–H is to (1) 

expand technical possibilities for the 

future of health, (2) forge a resilient 

health ecosystem to ensure optimal 

well-being for all, (3) drive scalable 

solutions to improve health care access 

and affordability, (4) build proactive 

health capacity to keep people from 

becoming patients, (5) foster data-driven 

innovation across the health ecosystem, 

and (6) increase the probability of 

successful transition. 

Section II. Organization 

ARPA–H consists of the following 

offices and personnel: 

The ARPA–H Office of the Director 

The ARPA–H Office of the Director 

(Director’s Office (DIRO)) is comprised 

of: 

1. The ARPA–H Director 

2. Deputy Director 

3. Chief of Staff 

4. Such other staff as necessary to 

support the Office of the Director. 

The ARPA–H Director is appointed by 

the President (42 U.S.C. 290c (1)) and 

reports directly to the Secretary of 

Health and Human Services. 42 U.S.C. 

290c (3). The Secretary has delegated all 

determinations regarding ARPA–H 

programs and operations to be in the 

sole authority and discretion of the 

Director. Consistent with 42 U.S.C. 

290c(c)(4)(B), this includes all decisions 

regarding the approval, termination and 

funding of all ARPA–H projects and 

programs. 

DIRO’s functions and responsibilities 

are as follows: (1) Oversee the creation 

of agency technical strategy, program 

approval, prioritization and 

implementation (2) Lead all aspects of 

internal Director’s Office operations, 

including ongoing management of the 

agency’s communications, legislative, 

governmental, legal, international, and 

mission office activities (3) Serve as the 

primary liaison for all Executive and 

Legislative functions of the 

organization, and fulfills principal level 

duties across HHS, including 

engagement with the Secretary and 

counselors (4) Serve as the primary 

liaison to Technical Staff, including 

program managers and their teams, and 

the Director’s Advisory staff to ensure 

consistent and effective coordination 

and communication. 

The Health Science Futures Office 

The Health Science Futures Office 

(HSFO) is comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the HSF Director. 

The HSFO’s functions and 

responsibilities are as follows: (1) 

Remove scientific and technological 

limitations that stymie our nation’s 

progress toward new solutions for the 

health care of the future. (2) Cultivate 

novel, agile tools that will facilitate 

revolutionary advances in medical care. 

(3) Leverage the latest scientific 

breakthroughs and invests in the 

development of platforms and 

technologies that do not yet exist. (4) 

Propose agency-sponsored research 

programs to the ARPA–H Director, 

ensuring they align with strategic 

objectives. 

The Resilient Systems Office 

The Resilient Systems Office (RSO) is 

comprised of is comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the RSO 

RSO’s mission and responsibilities are 

as follows: (1) Drive advances in health 

systems to improve their resilience, 

robustness, and interoperability, as well 

as their ability to adapt to unforeseen 

events, such as cyber-attacks, hospital 

closures, staffing shortages, emerging 

pathogens, and natural disasters. (2) 

Improve the continuity of care during 

regional and national emergencies, 

provides time savings to healthcare 

workforces, enhances quality of care 

across geographies, improves the 

robustness of clinical artificial 

intelligence (AI) applications, makes it 

easier for patients and clinicians to 

make informed decisions, and reduces 

gaps between advanced research and 

clinical care (3) Develop, implement, 

and manage novel, innovative scientific 

and technical programs aimed at 

improving health outcomes. (4) Propose 

agency-sponsored research programs to 

the ARPA–H Director, ensuring they 

align with strategic objectives. 

The Scalable Solutions Office 

The Scalable Solutions Office (SSO) is 

comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the SSO. 

SSO’s functions and responsibilities 

are as follows: (1) Aim to improve 

health care access and affordability for 

all Americans by working with partners 

to streamline manufacturing processes, 

optimize distribution networks, and 

develop innovative delivery methods to 

bring critical health technologies and 

treatments to underserved communities 

and remote areas. (2) Focus on 

advancing research and development to 

create scalable health solutions, 

expanding the reach of proven 

technologies, and accelerating their 

integration into the healthcare system. 


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107150 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 

(3) Develop, implement, and manage 

novel, innovative scientific and 

technical programs to democratize 

access to life-saving innovations and 

reduce disparities in health outcomes 

across the United States. (4) Propose 

agency-sponsored research programs to 

the ARPA–H Director, ensuring they 

align with strategic objectives. 

The Proactive Health Office 

The Proactive Health Office (PHO) is 

comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the PHO. 

PHO’s functions and responsibilities 

are as follows: (1) Improve personal 

health and wellness to reduce the 

likelihood that people will become 

patients. (2) Establish preventative 

programs that create new capabilities to 

identify and characterize disease risk, 

reduce comorbidities, and promote 

treatments and behaviors to address 

challenges to Americans’ health, 

whether those are viral, bacterial, 

physical, psychological, or caused by 

the natural aging process. (3) Develop, 

implement, and manage novel, 

innovative scientific and technical 

programs aimed at improving health 

outcomes. (4) Propose agency-sponsored 

research programs to the ARPA–H 

Director, ensuring they align with 

strategic objectives. 

The Project Accelerator Transition 

Innovation Office 

The Project Accelerator Transition 

Innovation Office (PATIO) is comprised 

of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the PATIO. 

PATIO’s missions and responsibilities 

are as follows: (1) Increase the 

probability that solutions thrive 

independently after they transition from 

ARPA–H. (2) Provide a wide variety of 

services to Program Managers (PMs) and 

ARPA–H performers throughout the 

entire program lifecycle. (3) Provide a 

tailored, full-suite of entrepreneurial 

and tech-to-market services to ARPA–H 

program managers and performers, 

including access to C-suite level talent 

to advise on various topics: clinical, 

business, user adoption, manufacturing, 

landscape analysis, and regulatory 

matters. (4) Manage ARPA–H’s Small 

Business Innovation Research (SBIR). 

(5) Ensure capabilities are primarily 

designed for user experience. Provide 

Minimum Viable Product (MVP) and 

market-testing experimentation to 

uncover insights into customer 

desirability, access, and trust. (6) 

Maintain ARPANET–H, including the 

Investor Catalyst and Customer 

Experience Hub and Spoke Network to 

create a Nationwide Health Innovation 

Network for ARPA–H to help 

performers bring their ideas to market. 

(7) Develop a unique portfolio to 

address challenging problems related to 

health for fostering revolutionary 

advances and paradigm shifts. (8) 

Propose agency-sponsored research 

programs to the ARPA–H Director, 

ensuring they align with strategic 

objectives. 

The Office of Operations 

The Office of Operations (OO) is 

comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the OO. 

OO’s functions and responsibilities 

are as follows: (1) Advise the ARPA–H 

Director and staff on the planning, 

development, and implementation of 

agency Business Operation services. (2) 

Lead all aspects of internal business 

operations, including ongoing 

management of the agency’s financial 

and budget activities, human capital, 

contracting and acquisitions, and other 

administrative and operational activities 

including but not limited to travel and 

training. (3) Oversee the creation of 

relevant business operations Standard 

Operating Procedures (SOPs), develops 

tracking and reporting processes and 

tools, provides high-level input to 

inform legal and financial risk, and 

develops systems that support 

administrative processes within the 

agency. (4) Oversee the Agency’s 

security related procedures and 

programs including research security 

risk and supply chain risk management. 

(5) Manage ARPA–H’s regional footprint 

and associated infrastructure across hub 

locations, including facilities and space 

management. (6) Oversee management 

of ARPA–H’s official records 

management in collaboration with 

Office of Information Technology and 

Data Innovation. 

The Office of Information Technology 

and Data Innovation 

The Office of Information Technology 

and Data Innovation (ITDI) is comprised 

of: 

1. The Chief Technology Officer 

2. The Chief Information Officer 

3. The Chief Information and Security 

Officer 

4. The Chief Data Officer 

5. Such other staff as necessary to 

support the ITDI Office. 

ITDI’s functions and responsibilities 

are as follows: (1) Advise the ARPA–H 

Director, staff, and programs on every 

aspect of Information Technology (IT) 

and Data modernization, governance, 

and allocation of relevant technology 

and communication resources to drive 

the agency’s mission. (2) Support the 

research, development, launch, and 

maintenance of tools to support data 

governance, innovation, and analytics 

across the agency, including data needs 

for program development. (3) Lead 

development of agency-wide IT, AI/ML, 

Technology Infrastructure, Cloud 

Computing, Networking, End User 

Computing, Cybersecurity, Technology 

Compliance, Telecommunications, and 

Responsible use of Technology Policy. 

(4) Develop and implement enterprise 

solutions to enable lean and agile 

business operations and collaboration. 

(5) Leads agency efforts to ensure user 

and data privacy and security 

management across all platforms and 

services. (6) Liaise with HHS and across 

the U.S. government to ensure 

compliance and consistency with U.S. 

government policy impacting IT tools 

and services, as well as data storage and 

analysis. (7) Conduct life cycle 

investment planning and monitoring as 

needed to support the areas listed 

above. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–31364 Filed 12–26–24; 11:15 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases; 


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