32174 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 

Both Melafind and Nevisense devices 

are intended for use on cutaneous 

lesions suspicious for melanoma when 

a dermatologist chooses to obtain 

additional information when 

considering biopsy. The committee will 

discuss if there is sufficient information 

to reclassify computer-aided devices for 

adjunctive diagnostic information of 

lesions suspicious for melanoma from 

class III to class II, and what special 

controls may be appropriate to provide 

reasonable assurance of safety and 

effectiveness for these devices if they 

are reclassified as class II devices. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website after the meeting. Background 

material is available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

July 11, 2022, will be provided to the 

panel. Oral presentations from the 

public will be scheduled on July 28, 

2022, between approximately 1 p.m. 

and 2 p.m. Eastern Time, and on July 

29, 2022, between approximately 1 p.m. 

and 2 p.m. Eastern Time. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before June 28, 2022. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 29, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallett, 

at Artair.Mallett@fda.hhs.gov or 301– 

796–9638, at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11420 Filed 5–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Establishment of the Advanced 

Research Projects Agency for Health 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Institutes of 

Health (NIH) has modified its structure. 

This notice announces the 

establishment of the Advanced Research 

Projects Agency for Health (or ARPA– 

H). 

DATES: This reorganization was 

approved by the Secretary of Health and 

Human Services and takes effect May 

24, 2022. 

SUPPLEMENTARY INFORMATION: Part N, 

National Institutes of Health, of the 

Statement of Organization, Functions, 

and Delegations of Authority for the 

Department of Health and Human 

Services (HHS) (May 27, 1975 at 40 FR 

22859, as amended most recently on 

November 3, 2004 at 69 FR 64081, and 

redesignated from Part HN as Part N on 

November 9, 1995 at 60 FR 56605, is 

amended as set forth below to 

implement ARPA–H. 

Section N, Organization and 

Functions is amended as follows: 

(1) Under Grants Management Branch 

(NW83, formerly HNW83) insert the 

following: 

Advanced Research Projects Agency 

for Health (NY, formerly HNY). (1) 

Provides leadership for high-risk, highreward biomedical and health research 

to speed application and 

implementation of health breakthroughs 

equitably. (2) Creates, supports, and 

manages programs to catalyze the 

development of transformative, 

evidenced-based, use-driven 

capabilities, platforms, and technologies 

in a range of biomedical and health 

research areas. (3) Facilitates 

partnerships and collaboration among 

government, academia, industry, and 

other sectors to accelerate the 

translation of innovation into 

meaningful and measurable benefits for 

the nation. (4) Converts use-driven 

research into tangible, sustainable 

solutions for patients. 

Acquisition and Contracting Office 

(NY2, formerly HNY2). (1) Advises the 

ARPA–H Director and staff on 

acquisition and contract and grant 

financial advisory services. (2) 

Develops/implements ARPA–H policies, 

provides oversight, and manages the 

operational components in the areas of 

acquisition and contracts management, 

including other transactions. (3) 

Manages and conducts a comprehensive 

program of all research and 

development contracting, non-research 

and development contracting, ARPA–H 

support contracting, and commercial 

item acquisitions using simplified 

acquisition procedures, GSA Federal 

Supply Schedule acquisitions and 

simplified acquisitions. (4) Provides 

advice and assistance regarding all 

phases of the acquisition cycle from 

planning to closeout with the purpose of 

accomplishing all acquisitions needed 

for the scientific mission and all related 

acquisitions required by its customers. 

Comptroller’s Office (NY3, formerly 

HNY3). (1) Directs ARPA–H-wide 

budget policy, planning, analysis, 

formulation, and presentation, in 

collaboration with HHS Office of the 

Assistant Secretary for Financial 

Resources and NIH Office of Budget. (2) 

Manages the ARPA–H appropriated 

budget, including reprogramming and 

coordination of the use of the Director’s 

Discretionary Fund and transfer 

authority. (3) Advises the ARPA–H 

Director and staff and provides 

leadership and direction for budgetary 

matters and financial management 

activities. (4) Develops policies and 

instructions for central services budget 

preparation and presentation. (5) 

Administers allocation of funds and 

manages a system of fund and budgetary 

controls. (6) Provides an ARPA–H 

manpower resource control system 

designed to allocate resources. (7) 

Provides, develops, and maintains an 

ARPA–H Management Account 


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Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 32175 

Structure. (8) Directs planning and 

implementation of ARPA–H fiscal 

systems and procedures, in coordination 

with NIH and/or HHS fiscal systems and 

procedures, and provides accounting 

services to all ARPA–H components. (9) 

Supports the Office of Acquisition and 

Contracting (OAC) in the development 

of policies and procedures pertaining to 

grants and contracts. 

Engagement and Communications 

Office (NY4, formerly HNY4). (1) Plans 

and directs activities to communicate 

information about ARPA–H programs 

and accomplishments to the general 

public, scientific community, patients 

and patient groups, professional 

societies and organizations, and public 

advocacy groups. (2) Advises the 

Director of ARPA–H on effective 

communications strategies. (3) 

Represents the Director of ARPA–H in 

relations with media, scientific 

publications, and other public 

stakeholder groups. (4) Coordinates 

communications policy, strategy, and 

activities, including Freedom of 

Information Act requests, with the NIH 

Office of Communications and Public 

Liaison. (5) Leads internal and external 

engagement activities and outreach 

efforts to develop, build, and improve 

ARPA–H relationships with 

stakeholders. (6) Develops and 

implements initiatives to collect 

feedback and gain support of ARPA–H 

research initiatives. (7) Collaborates 

with the ARPA–H Office of Legislative 

and Congressional Affairs on a range of 

external advocacy initiatives in 

furtherance of ARPA–H’s mission. (8) 

Creates and publishes public and 

agency information resources including 

regular publications in a variety of 

formats. (9) Fosters participation in and 

promotion of ARPA–H activities. (10) 

Maintains resources for ARPA–H 

special events, recruitment initiatives 

and other public-facing activities. 

Legislative and Governmental Affairs 

Office (NY5, formerly HNY5). (1) 

Advises the ARPA–H Director and staff 

on the full range of legislative and 

intragovernmental issues, and provides 

leadership and direction for ARPA–H 

legislative analysis, development, and 

liaison. (2) Identifies, analyzes, and 

reports on legislative developments 

relevant to ARPA–H programs and 

activities and the national biomedical 

and health research effort. (3) Monitors 

new legislative proposals and their 

progress through the legislative process, 

including changes in the statutory base 

of ARPA–H activities, and develops and 

coordinates technical assistance. (4) 

Assesses, monitors, and manages the 

ARPA–H relationship with the ARPA–H 

Congressional Authorizing and 

Appropriations Committees, as well as 

other agencies across the federal 

government, and takes necessary action 

to facilitate improvements in these 

relationships. (5) Provides coordination 

on ARPA–H legislative matters with the 

NIH, HHS, Congress, Federal Agencies, 

and other non-Federal national and 

international organizations. (6) 

Coordinates the preparation of 

testimony or statements for ARPA–H 

leadership before congressional 

committees or other groups. (7) 

Develops responses to Congressional 

requests, develops responses to report 

language, and special reports, staff 

documents, or other materials 

concerning ARPA–H interests, 

activities, and relationships. 

Strategic Resources Office (NY6, 

formerly HNY6). (1) Advises the ARPA– 

H Director and staff on all phases of 

ARPA–H-wide administration and 

management. (2) Provides leadership 

and direction to all aspects of ARPA–H 

management. (3) Oversees the 

management of functions in the areas of 

personnel management, management 

policy, management assessment, and 

logistics management, IT support, 

safety, space and facility management, 

property, support services, and security 

operations. (4) Coordinates with and 

serves as a liaison to the relevant NIH 

offices to provide a high-level of service 

to ARPA–H staff. 

Treatment Innovation Office (NY7, 

formerly HNY7). (1) Furthers 

development of novel and innovative 

therapeutics or other interventions to 

manage, treat, or cure diseases and 

conditions. (2) Advises the ARPA–H 

Director on matters concerning ARPA– 

H-sponsored research activities related 

to disease or condition management 

therapies. (3) Responds to requests for 

information on highly technical matters 

and matters of public policy related to 

therapeutics and treatment 

interventions. 

Health Equity, Dissemination, and 

Implementation Office (NY8, formerly 

HNY8). (1) Advances programs that 

concentrate on promoting health equity, 

access to care, and ethical aspects of 

science and technology development. 

(2) Undertakes projects and initiatives to 

address and lessen health disparities 

and inequities in biomedical and health 

research within the United States and 

abroad. (3) Advises the ARPA–H 

Director on matters concerning ARPA– 

H-sponsored research activities related 

to health equity, inclusion, recruitment, 

enrollment, and retention, access to 

care, and ethical aspects of science and 

technology development, as well 

dissemination and implementation of 

those research advances into real-world 

settings and clinical practice. (4) 

Responds to requests for information on 

highly technical matters and matters of 

scientific and public policy related to 

health equity, inclusion, recruitment, 

enrollment, and retention, access to 

care, and ethical aspects of science and 

technology development, as well 

dissemination and implementation of 

those research advances into real-world 

settings and clinical practice. 

Health Data Office (NY9, formerly 

HNY9). (1) Focuses on thoughtful 

approaches to revolutionizing how 

scientific and health data and 

information technology are collected, 

organized, integrated, and used. (2) 

Develops strategies to assemble 

interdisciplinary teams to fuse 

mathematical approaches and 

biomedical research creating massive 

datasets that are carefully annotated, 

made widely available, allow for 

integration across programs, and are 

sensitive to issues of subject consent, 

personal privacy, and unintended biases 

that are crucial for addressing the most 

significant biomedical problems faced 

by society. (3) Advises the ARPA–H 

Director on matters concerning ARPA– 

H-sponsored research activities related 

to health data and information 

technology. (4) Responds to requests for 

information on highly technical matters 

and matters of scientific and public 

policy related to health data and 

information technology. 

Health Promotion and Disease 

Detection Office (NYA, formerly HNYA). 

(1) Advances approaches, interventions, 

and technologies that further the overall 

health and wellness of Americans and 

prevent diseases. (2) Promotes 

innovation in tools, technologies, 

processes, or other approaches that 

enhance early detection of diseases. (3) 

Advises the ARPA–H Director on 

matters concerning ARPA–H-sponsored 

research activities related to health 

promotion and disease detection. (4) 

Responds to requests for information on 

highly technical matters and matters of 

public policy related to health 

promotion and disease detection. 

Health Resources and Policies Office 

(NYB, formerly HNYB). (1) Advances 

progress in confronting challenges to the 

overall ecosystem of biomedical and 

health research, whether they be 

processes, policies, or models, to enable 

acceleration of advances. (2) Applies 

scientific and engineering principles to 

solve challenges that delay the delivery 

of technologies, interventions, or other 

approaches to the patient. (3) Advises 

the ARPA–H Director on matters 

concerning ARPA–H-sponsored 

research activities related to health 

resources and policy. (4) Responds to 


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requests for information on highly 

technical matters and matters of 

scientific and public policy related to 

health resources and policy. 

Systems Technology Office (NYC, 

formerly HNYC). (1) Focuses on those 

systems that impact health—from 

physiologic systems (e.g., immune) to 

the healthcare system and everything in 

between. (2) Speeds progress in the 

integration of systems, including and 

especially technological approaches to 

doing so. (3) Advises the ARPA–H 

Director on matters concerning ARPA– 

H-sponsored research activities related 

to health systems technology. (4) 

Responds to requests for information on 

highly technical matters and matters of 

scientific and public policy related to 

health systems technology. 

Equity and Inclusion Office (NYD, 

formerly HNYD). (1) Coordinates, 

facilitates, and supports programs to 

ensure equity, diversity, and inclusion 

in all aspects of ARPA–H’s work. (2) 

Provides strategic and programmatic 

leadership for ARPA–H’s efforts to 

reduce health disparities and foster 

health equity in biomedical research. (3) 

Evaluates ARPA–H’s progress towards 

achieving greater diversity and health 

equity in biomedical and health 

research. (4) Promotes ARPA–H efforts 

to build a diverse cohort of 

collaborators, staff, performers, and 

others. 

Strategic Planning, Evaluation, and 

Analytics Office (NYE, formerly HNYE). 

(1) Oversees ARPA–H-wide planning, 

evaluation, and analysis/analytic 

activities. (2) Advises ARPA–H 

leadership and staff on all aspects of 

strategic planning, reporting, and 

operational effectiveness for ARPA–H 

activities. (3) Provides leadership and 

guidance to ARPA–H’s business 

community in the development and 

oversight of a strategic administrative 

management plan, goals, organizational 

effectiveness and business analytics. (4) 

Oversees the development of analytic 

and evaluation strategies to drive greater 

efficiency and effectiveness in 

administrative and programmatic 

operations. 

Innovation and Entrepreneurship 

Office (NYF, formerly HNYF). (1) 

Inspires innovation and creativity 

throughout ARPA–H, including 

stimulating the culture of innovation, 

ideation, and dynamic thinking and 

leveraging design research and design 

thinking. (2) Promotes practical 

strategies to provide resources for 

programs and projects to incorporate 

and implement transition principles to 

inform innovation in overall ARPA–H 

commercialization strategies. (3) Serves 

as the ARPA–H focal point for the 

management of all Small Business 

Innovation Research (SBIR) and Small 

Business Technology Transfer (STTR) 

Program activities, and implementation 

of pertinent legislation, rules and 

regulations and associated matters 

related to the SBIR/STTR Program. (4) 

Proposes and implements innovative 

strategies to promote the 

commercialization of innovative high 

impact technologies including research 

tools, medical devices, and therapeutics 

throughout the program development 

and management lifecycle. (5) Assesses 

the commercial potential of ARPA–H 

technology priorities and provides 

guidance on how best to structure 

programs, projects, and goals for 

successful transition. 

Delegations of Authority: All 

delegations and redelegations of 

authority to officers and employees of 

NIH that were in effect immediately 

prior to the effective date of this 

amendment and are consistent with this 

amendment shall continue in effect, 

pending further redelegation. 

Dated: May 24, 2022. 

Xavier Becerra, 

Secretary, U.S. Department of Health and 

Human Services. 

[FR Doc. 2022–11519 Filed 5–25–22; 4:15 pm] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Frederick National 

Laboratory Advisory Committee to the 

National Cancer Institute. 

The meeting will be held virtually 

and is open to the public. Individuals 

who plan to view the virtual meeting 

and need special assistance or other 

reasonable accommodations to view the 

meeting, should notify the Contact 

Person listed below in advance of the 

meeting. The meeting will be videocast 

and can be accessed from the NIH 

Videocasting and Podcasting website 

(http://videocast.nih.gov). 

Name of Committee: Frederick National 

Laboratory Advisory Committee to the 

National Cancer Institute. 

Date: June 27, 2022. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: Ongoing and new activities at the 

Frederick National Laboratory for Cancer 

Research. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Rockville, 

MD 20850 (Virtual Meeting). 

Contact Person: Wlodek Lopaczynski, 

M.D., Ph.D., Assistant Director, Office of the 

Director, Division of Extramural Activities, 

National Cancer Institute, National Institutes 

of Health, 9609 Medical Center Drive, 

Seventh Floor, West Tower, Room 7W514, 

Bethesda, MD 20892, (240) 276–6458, 

lopacw@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: FNLAC: 

https://deainfo.nci.nih.gov/advisory/fac/ 

fac.htm, where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: May 24, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–11458 Filed 5–26–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) 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: Center for Inherited 

Disease Research Access Committee. 

Date: July 8, 2022. 

Time: 11:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


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