Federal Register / Vol. 86, No. 167 / Wednesday, September 1, 2021 / Notices 49035 

which it partners to support these 

activities. This study aims to present an 

internally valid description of RSER 

approaches used by six purposively 

selected programs, not to promote 

statistical generalization to different 

sites or service populations. 

DATES: Comments due within 30 days of 

publication. OMB is required to make a 

decision concerning the collection of 

information between 30 and 60 days 

after publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: The Head Start REACH: 

Strengthening Outreach, Recruitment 

and Engagement Approaches with 

Families project is proposing to conduct 

qualitative case studies to examine the 

approaches used by Head Start 

programs to recruit, select, enroll, and 

retain families experiencing adversities 

and the implementation of these 

approaches, including supporting 

factors and barriers. Adversities is a 

broad term that refers to a wide range 

of circumstances or events that pose a 

threat to a child or caregiver’s physical 

or psychological well-being. The 

adversities that families experience are 

often intertwined with poverty, may cooccur, and are affected by systematic 

factors, such as structural racism. 

Common examples include (but are not 

limited to) families experiencing 

homelessness; involvement in child 

welfare, including foster care; and 

affected by substance use, mental health 

issues, and domestic violence. 

We will collect information from six 

sites; each site will include (1) a Head 

Start program that has demonstrated 

success in the RSER of families 

experiencing adversities and (2) up to 

four of its community partner 

organizations that serve families 

experiencing adversities. 

We will collect information on how 

programs determine which adversities 

to focus on for their RSER efforts; RSER 

approaches programs use, focusing 

specifically on families experiencing 

adversities; RSER-related training and 

support that Head Start staff receive; 

partnerships that programs form with 

organizations in the community to 

support these activities; and supporting 

factors and barriers to participation of 

enrolled and non-enrolled families who 

face adversities. 

Respondents: Head Start program 

directors, Head Start staff conducting 

eligibility, recruitment, selection, 

enrollment, attendance (ERSEA) 

activities, staff from community 

organizations with which Head Start 

programs partner for ERSEA activities, 

Head Start-eligible parents enrolled in 

Head Start, and those not enrolled in 

Head Start. 

Annual Burden Estimates 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

Program director recruitment call protocol (Instrument 1) ............................... 6 1 0.50 3.0 

Program staff interview protocol: Program director (Instrument 2) a ............... 6 1 1.0 6.0 

Program staff interview protocol ERSEA staff (Instrument 2) a ....................... 24 1 1.5 36 

Head Start program study activities and focus group coordination b .............. 6 1 8.0 48 

Head Start enrolled families focus group guide (Instrument 3) ...................... 60 1 1.5 90 

Community partner recruitment call protocol (Instrument 4) ........................... 24 1 0.17 4.0 

Community partner staff interview protocol (Instrument 5) ............................. 24 1 0.75 18 

Community partner focus group coordination b ............................................... 6 1 3.0 18 

Families not enrolled in Head Start focus group guide (Instrument 6) c ......... 60 1 1.5 90 

aThere is one interview protocol for both the program director and the ERSEA staff and the interviewer will tailor it to the respondent(s). bThere is no instrument, only a document of duties associated with this activity. 

c If needed, we will offer the option of a 45-minute one-on-one interview; however, as we do not expect to have to use the interview option 

often, the table reflects a 90-minute burden for all families not enrolled in Head Start. 

Estimated Total Annual Burden 

Hours: 313. 

Authority: Head Start Act Section 640 

[42 U.S.C. 9835] 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–18917 Filed 8–31–21; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0860] 

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 

November 4, 2021, from 10 a.m. to 4 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
49036 Federal Register / Vol. 86, No. 167 / Wednesday, September 1, 2021 / Notices 

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–2021–N–0860. 

The docket will close on November 3, 

2021. Submit either electronic or 

written comments on this public 

meeting by November 3, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before November 3, 2021. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 3, 2021. 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 

October 21, 2021, 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– 

2021–N–0860 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 

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

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

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 new drug 

application (NDA) 214812, for 

carbetocin nasal spray, submitted by 

Levo Therapeutics, Inc., for the 

proposed treatment of hyperphagia, 

anxiety, and distress behaviors 

associated with Prader-Willi syndrome. 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 167 / Wednesday, September 1, 2021 / Notices 49037 

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 

October 21, 2021, will be provided to 

the committee. Oral presentations from 

the public will be scheduled between 

approximately 1:30 p.m. and 2:30 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 October 

13, 2021. 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 October 14, 2021. 

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: August 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18892 Filed 8–31–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–new] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before October 1, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990-New-30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Components 

Study of REAL Essential Curriculum. 

Type of Collection: New. 

OMB No. 0990–NEW—Office of 

Population Affairs—OASH—OS. 

Abstract: The Office of Population 

Affairs (OPA), U.S. Department of 

Health and Human Services (HHS) is 

requesting 3 years of approval by OMB 

on a new collection. The Components 

Study of REAL Essential Curriculum 

will identify the components that matter 

the most for promoting positive health 

behaviors and outcomes among 

adolescents. The study will examine 

program components (for example, 

content and dosage), implementation 

components (for example, attendance 

and engagement), and contextual 

components (for example, participant 

characteristics) to determine which 

components influence participant 

outcomes the most. In addition, the 

study will measure youth engagement in 

programming from various perspectives 

and examine the role of engagement as 

a mediating factor to achieving youth 

outcomes. Sites participating in the 

study will use the REAL Essentials 

Advance (REA) relationship curriculum, 

a popular program among federal 

pregnancy prevention grantees. The 

study will enroll schools from spring to 

fall 2022 (and possibly spring 2023, if 

necessary). The study will collect youth 

surveys at baseline, at program exit, and 

6 months following the completion of 

the program. The study will also collect 

extensive implementation data, which 

includes youth engagement exit ticket 

surveys after REA sessions, focus groups 

with youth, program facilitator logs, and 

attendance records. Study staff will also 

interview facilitators and site 

leadership. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of 

respondent 

Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Youth outcome survey ..................................................................................... 498 3 40/60 996 

Youth-focus groups .......................................................................................... 133 1 90/60 200 

Youth-engagement exit ticket .......................................................................... 533 12 2/60 213 

Program Facilitators—Fidelity log .................................................................... 13 24 10/60 52 

Program Facilitators—interview topic guide .................................................... 5 2 1 10 

District/School/CBO leadership- interview topic guide .................................... 11 2 45/60 17 

Total .......................................................................................................... 1193 44 ........................ 1488 


khammond on DSKJM1Z7X2PROD with NOTICES