Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 26213 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will discuss supplemental 

new drug applications 210793–s008 and 

207318–s011, efficacy supplement 

resubmission for NUPLAZID 

(pimavanserin) tablets, submitted by 

Acadia Pharmaceuticals Inc., for the 

proposed treatment of hallucinations 

and delusions associated with 

Alzheimer’s disease psychosis. 

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 at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

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 

June 3, 2022, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 2 p.m. and 3 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 May 25, 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 May 26, 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 Joyce 

Frimpong (see FOR FURTHER INFORMATION

CONTACT) 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/Advisory

Committees/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: April 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09433 Filed 5–2–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: SAMHSA, HHS. 

ACTION: Notice. 

SUMMARY: The Substance Abuse and 

Mental Health Services Administration 

has modified its structure. This new 

organizational structure was approved 

by the Deputy Secretary of Health and 

Human Services and effective on April 

14, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Robert T. Atanda, Ph.D., Director, 

Division of Management Services, Office 

of Management, Technology, and 

Operations, Substance Abuse and 

Mental Health Services Administration, 

Parklawn Building, Room 12E49, 5600 

Fishers Lane, Rockville, MD 20857, 

Phone: 240–276–2826. 

Part M of the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services (DHHS) at 73, Number 

147, pages 44274–44275, July 30, 2008, 

is amended to reflect the new functional 

statement for the Office of the Assistant 

Secretary for Mental Health and 

Substance Use (OAS). This notice 

identifies a new Office of 988 and 

Behavioral Health Crisis Coordination 

(988) and Office of Recovery (OR). This 

change allows innovative prevention 

implementation. The changes are as 

follows: 

Section M.20, Functions is amended 

as follows: 

The functional statement for the 

Office of the Assistant Secretary is 

amended to name a new Office of 988 

and Behavioral Health Crisis 

Coordination (988) and Office of 

Recovery (OR). The functional statement 

for each office is as follows: 

Office of 988 and Behavioral Health 

Crisis Coordination 

(1) 988 (988 is the dialing code for the 

National Suicide Prevention Lifeline) 

provides leadership in planning, 

implementing, and evaluating the 

office’s goals, priorities, policies, and 

programs, and is the focal point for the 

Department’s efforts on 988 and 

Behavioral Health Crisis Coordination; 

(2) plans, directs, and provides overall 

administration of the programs of the 

office; (3) conducts and coordinates 

office interagency, interdepartmental, 

and intergovernmental activities; (4) 

provides information to the public and 

constituent organizations on 988 and 

Behavioral Health Crisis Coordination 

activities; (5) maintains liaison with 

national organizations, other Federal 

departments/agencies, and with other 

SAMHSA Centers and Offices; (6) 

administers internal and external 

committee management (7) conducts 

services quality and financing activities 

and coordinates these activities with 

other components in SAMHSA; and (8) 

works with SAMHSA’s Labor and 

Employee Relation staff to monitor the 

conduct of equal employment 

opportunity activities of the Office of 

988 and Behavioral Health Crisis 

Coordination. 

Office of Recovery 

Recovery from substance use and/or 

mental health disorders is a life journey 

that allows individuals to change by 

improving their health and wellness. 

The Office of Recovery (OR): (1) 

Provides leadership in the identification 

of new and emerging issues related to 

recovery support services in major 

SAMHSA programs (2) provides 

leadership, coordination, and direction 

in the development and implementation 

of the Office of Recovery goals and 

priorities, and serves as the focal point 

for the Department’s efforts on recovery 

support services; (3) plans, directs, and 

provides overall administration of the 

programs and activities of the Office of 

Recovery; (4) manages special projects 


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26214 Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 

and external liaison activities; and (5) 

directs Office of Recovery’s overall 

human resource activities and works 

with SAMHSA’s Labor and Employee 

Relations staff to monitor the conduct of 

equal employment opportunity 

activities for the Office of Recovery. 

Office of the Assistant Secretary for 

Mental Health and Substance Use (MA) 

The Office of the Assistant Secretary 

for Mental Health and Substance Use 

(OAS): (1) Maintains a system to 

disseminate research findings and 

evidence-based practices to service 

providers to improve treatment and 

prevention services and incorporate 

these findings into SAMHSA programs; 

(2) ensures that grants are subject to 

performance and outcome evaluations 

and that center directors consistently 

document the grant process and conduct 

ongoing oversight of grantees; (3) 

consults with stakeholders to improve 

community-based and other mental 

health services, including adults with a 

serious mental illness (SMI), and 

children with a serious emotional 

disturbance (SED); (4) collaborates with 

other federal departments, including the 

Departments of Defense (DOD), Veterans 

Affairs (VA), Housing and Urban 

Development (HUD), and Labor (DOL) 

to improve care for veterans and service 

members, and support programs to 

address chronic homelessness; and (5) 

works with stakeholders to improve the 

recruitment and retention of mental 

health and substance use disorder 

professionals. In addition, the OAS 

provides leadership in the development 

of agency policies and programs, and 

maintains a close working relationship 

and coordination with Congress, other 

operating and staff divisions within the 

Department of Health and Human 

Services, and external Federal and 

private sector entities. 

The OAS consists of the Office of 

Intergovernmental and External Affairs, 

the Office of Behavioral Health Equity 

and Justice-Involved, the Office of 

Tribal Affairs and Policy/Office of 

Indian Alcohol and Substance Abuse, 

and the Office of the Chief Medical 

Officer. 

Office of Intergovernmental and 

External Affairs (MAC) 

The Office of Intergovernmental and 

External Affairs (OIEA) serves as the 

central point for providing leadership 

and coordination in establishing and 

maintaining a collaborative effort 

between SAMHSA, other government 

agencies, and service providers in order 

to improve behavioral health outcomes. 

The Office is SAMHSA’s lead for 

institutional and intergovernmental 

communication and coordination. As 

such, the Office: (1) Ensures that critical 

information from the field is 

incorporated into all policy activities 

and shared broadly across SAMHSA to 

support program development and 

implementation; (2) establishes and 

sustains relationships between 

SAMHSA and key stakeholders in other 

government agencies and institutions; 

(3) ensures that SAMHSA’s policies are 

effectively communicated to Regional 

and National stakeholders; and, (4) 

meets routinely with staff from Centers 

and Offices to discuss program policy 

issues, seek input, and review progress. 

Office of Behavioral Health Equity and 

Justice-Involved (MACA) 

The Office of Behavioral Health 

Equity and the Justice-Involved 

(OBHEJI) coordinates agency efforts to 

ensure that racial and ethnic minority, 

underserved, and criminal justiceinvolved populations have equitable 

access to high quality behavioral health 

care. Functions of the office include: (1) 

Strengthening SAMHSA’s capacity, 

through its grant programs and technical 

assistance efforts, to address the 

behavioral health needs of minority, 

underserved and justice involved 

populations; (2) enhancing 

measurement and data strategies to 

identify, assess and respond to the 

behavioral health challenges for these 

populations; (3) promoting policy 

initiatives that strengthen SAMHSA’s 

programs and the broader field in 

improving the behavioral health of the 

underserved and the justice-involved; 

and, (4) expanding the behavioral health 

workforce capacity to improve outreach, 

engagement and quality of care. 

Office of Tribal Affairs and Policy/ 

Office of Indian Alcohol and Substance 

Abuse (MACB) 

The Office of Tribal Affairs and Policy 

(OTAP)/Office of Indian Alcohol and 

Substance Abuse (OIASA) coordinates 

federal partners and provides tribes 

with technical assistance and resources 

to develop and enhance prevention and 

treatment programs for substance use 

disorders, including the misuse of 

alcohol. The Office serves as the 

agency’s primary point of contact for 

tribal governments, tribal organizations, 

and federal agencies on behavioral 

health issues that impact tribal 

communities. 

OTAP/OIASA is charged with 

aligning, leveraging, and coordinating 

federal agencies and departments in 

carrying out SAMHSA’s responsibilities 

delineated in the Tribal Law and Order 

Act (TLOA). This effort is overseen 

through the Indian Alcohol and 

Substance Abuse (IASA) 

Interdepartmental Coordinating 

Committee, which is comprised of more 

than 60 members representing a range of 

federal agencies and departments. 

Health Financing and Policy Branch 

(MACC) 

Leads the Health Financing and 

Policy efforts on behalf of the Agency. 

Maintains relationships with the 

Centers for Medicare & Medicaid 

Services (CMS), Public, and Commercial 

insurance sector to ensure Agency 

influence and support for behavioral 

health services within Medicare, 

Medicaid, and private insurance plans. 

Oversees Agency role in CMS Medicaid 

waiver programs. Maintains Agency 

voice on mental health and substance 

use parity laws. Agency Regulatory 

Officer. 

Executive Correspondence and Support 

Branch (MACD) 

The Executive Correspondence and 

Support Branch: (1) Receives, analyzes, 

assigns, distributes and tracks executive 

correspondence and maintains files; (2) 

ensuring responsiveness, quality and 

timeliness of executive correspondence; 

(3) issues guidance and establishes 

administrative processes to ensure that 

executive correspondence complies 

with all DHHS requirements and reflects 

positively on the reputation of 

SAMHSA; and, (4) responds to Freedom 

of Information Act requests. 

Office of the Chief Medical Officer 

(MAD) 

The Office of the Chief Medical 

Officer (OCMO) provides assistance to 

the Assistant Secretary in evaluating 

and organizing programs within the 

Agency, and to promote evidence-based 

and promising best practices 

emphasizing clinical focus. The OCMO 

has in-depth experience providing 

mental health care or substance use 

disorder treatment services. 

Furthermore, the OCMO coordinates 

with the Assistant Secretary for 

Planning and Evaluation (ASPE) to 

assess the use of performance metrics to 

evaluate SAMHSA programs, and to 

coordinate with the Assistant Secretary 

to ensure consistent utilization of 

appropriate performance metrics and 

evaluation designs. 

Delegation of Authority 

All delegations and re-delegations of 

authority made to SAMHSA officials 

that were in effect immediately prior to 

this reorganization, and that are 

consistent with this reorganization, 

shall continue in effect pending further 

re-delegation. 


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Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 26215 

Dated: April 27, 2022. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2022–09404 Filed 5–2–22; 8:45 am] 

BILLING CODE 4162–20–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 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group; Diabetes, 

Endocrinology and Metabolic Diseases B 

Study Section. 

Date: May 31–June 2, 2022. 

Time: 10:00 a.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Democracy Two, 6707 Democracy Blvd., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Charlene J. Repique, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7347, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–7791, 

charlene.repique@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: April 27, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09395 Filed 5–2–22; 8:45 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 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK SBIR 

Applications Developing New Technologies 

for Development and Integration of Novel 

Components for Open and Closed Loop 

Hormone Replacement Platforms for T1D 

Therapy. 

Date: May 27, 2022. 

Time: 2:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Democracy II, 6707 Democracy Blvd., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ryan G. Morris, Ph.D., 

Scientific Review Officer, Review Branch, 

Division of Extramural Activities, NIDDK, 

National Institutes of Health, Room 7015, 

6707 Democracy Boulevard, Bethesda, MD 

20892–2542, 301–594–4721, ryan.morris@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: April 27, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09403 Filed 5–2–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Resource Related 

Research Projects (R24 Clinical Trial Not 

Allowed). 

Date: May 20, 2022. 

Time: 10:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Sandip Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G42, 

Rockville, MD 20852, (240) 292–0189, 

sandip.bhattacharyya@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: April 27, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–09432 Filed 5–2–22; 8:45 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 10(d) of the 

Federal Advisory Committee Act, as 


lotter on DSK11XQN23PROD with NOTICES1