26212 Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0557] 

Psychopharmacologic Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Psychopharmacologic 

Drugs Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on June 

17, 2022, from 8:45 a.m. to 4:30 p.m. 

Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm408555.

htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0557. 

The docket will close on June 16, 2022. 

Submit either electronic or written 

comments on this public meeting by 

June 16, 2022. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 16, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 16, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before June 

3, 2022, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–N–0557 for 

‘‘Psychopharmacologic Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.govinfo.

gov/content/pkg/FR-2015-09-18/pdf/ 

2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Frimpong, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–7973, Fax: 301–847–8533, email: 

PDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 


lotter on DSK11XQN23PROD with NOTICES1
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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