Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices 45739 

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: 

James R. Hunter, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5150, Silver Spring, 

MD 20993–0002, 301–796–3156, 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 23, 

2021 (86 FR 39038), FDA published a 

notice entitled ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; 4F– 

MDMB–BICA (4F–MDMB–BUTICA); 

Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine, 

7-hydroxymitragynine); Phenibut’’ that 

requested comments for consideration 

in preparing a response from the United 

States to the WHO regarding the abuse 

liability and diversion of these drugs. 

WHO will use this information to 

consider whether to recommend that 

certain international restrictions be 

placed on these drug substances. To 

allow interested persons additional time 

to submit comments, FDA is reopening 

the comment period until August 24, 

2021. 

Dated: August 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17498 Filed 8–11–21; 4:15 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: The HRSA 

Community-Based Outreach Reporting 

Module, OMB # 0906–0064, Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: HRSA requests an extension 

to continue data collection for the 

Community-Based Workforce for 

COVID–19 Vaccine Outreach Programs 

(CBO Programs) (OMB # 0906–0064). In 

compliance with the requirement for 

opportunity for public comment on 

proposed data collection projects of the 

Paperwork Reduction Act of 1995, 

HRSA announces plans to submit an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB). Prior 

to submitting the ICR to OMB, HRSA 

seeks comments from the public 

regarding the burden estimate, below, or 

any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than October 15, 2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 

Information Collection Request Title: 

The HRSA Community-Based Outreach 

Reporting Module, OMB # 0906–0064, 

Extension. 

Abstract: HRSA requests approval of 

an extension of the current emergency 

ICR to continue data collection for the 

Community-Based Workforce for 

COVID–19 Vaccine Outreach Programs 

(CBO Programs), which support 

nonprofit private or public 

organizations to establish, expand, and 

sustain a public health workforce to 

prevent, prepare for, and respond to 

COVID–19. This data is needed to 

comply with requirements to monitor 

funds distributed under the American 

Rescue Plan Act of 2021 and in 

accordance with OMB Memorandum 

M–21–20. 

Need and Proposed Use of the 

Information: HRSA is requesting 

approval from OMB for an extension of 

the current emergency data collection 

module to support HRSA’s Healthcare 

Systems Bureau and Office of Planning, 

Analysis, and Evaluation requirements 

to monitor and report on funds 

distributed. As part of the American 

Rescue Plan Act of 2021, signed into 

law on March 11, 2021 (Pub. L. 117–2), 

HRSA has awarded nearly $250 million 

to develop and support a communitybased workforce that will engage in 

locally tailored efforts to build vaccine 

confidence and bolster COVID–19 

vaccinations in underserved 

communities. In June and July, under 

the CBO Programs, HRSA awarded 

funding to over 140 local and national 

organizations. These organizations are 

responsible for educating and assisting 

individuals in accessing and receiving 

COVID–19 vaccinations. This includes 

activities such as conducting direct faceto-face outreach and other forms of 

direct outreach to community members 

to educate them about the vaccine, 

assisting individuals in making a 

vaccine appointment, providing 

resources to find convenient vaccine 

locations, and assisting individuals with 

transportation or other needs to get to a 

vaccination site. The program will 

address persistent health disparities by 

offering support and resources to 

vulnerable and medically underserved 

communities, including racial and 

ethnic minority groups and individuals 

living in areas of high social 

vulnerability. 

HRSA is proposing a new data 

reporting module—the CommunityBased Vaccine Outreach Program 

Reporting Module—to collect 

information on CBO Program-funded 

activities. The CBO Program will collect 

monthly progress report data from 

funded organizations. This data will be 

related to the public health workforce, 

the vaccine outreach activities 

performed by this workforce, and the 

individuals who received vaccinations 

by this workforce in a manner that 

assesses equitable access to vaccine 

services and that the most vulnerable 

populations and communities are 

reached. This data will allow HRSA to 

clearly identify how the funds are being 

used and monitored throughout the 

period of performance and to ensure 

that high-need populations are being 

reached and vaccinated. Responses to 

some data requirements are only 

reported during the initial reporting 

cycle (e.g., the name, location, 

affiliation, etc. of the individual 

supporting community outreach), 

though respondents may update the 

data should any of that change during 

the duration of the reporting period. 

Likely Respondents: Respondents are 

community outreach workers employed 

by entities supported by HRSA grant 

funding over a period of either 6 months 

(HRSA–21–136) or 12 months (HRSA– 

21–140). 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 


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45740 Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total Estimated Annualized Burden 

Hours: 

Form name 

Number of unique 

organizations 

funded through 

the two programs 

Number of 

respondents 

Number of 

responses per 

respondent 

Total responses 

Average burden per 

response 

(in hours) 

Total burden hours 

Community outreach 

worker profile form.

14 cooperative 

agreement awards 

for HRSA–21–136 

and 127 grant 

awards for HRSA– 

21–136.

Total number of 

Community outreach workers deployed through the 

work of the two 

programs.

One response per 

respondent.

Reported once 

across the duration 

of the programs 

(the period of performance for 

HRSA–21–136 is 6 

months, and for 

HRSA–21–140 is 

12 months).

Sampled response 

times of approximately 15 minutes 

per response.

Total hours spent on 

responses for all 

funded organizations over a 2-year 

period. 

131 (est.) .................. 3,000 (est.) ............... 1 ............................... 3,000 ........................ 0.27 hours ................ 800. 

Form name 

Number of 

community 

outreach workers 

Number of 

respondents over 

the period of 

the programs 

Number of 

responses per 

respondent 

Total responses 

Average burden per 

response 

(in hours) 

Total burden hours 

Vaccine-site data— 

outreach to community members form.

Number of community outreach workers deployed for 6 

months (HRSA– 

21–136) or 12 

months (HRSA– 

21–140) of support.

Number of community members in 

contact with community outreach 

workers.

One response per 

respondent or less 

(e.g., one response from the 

audience of a 

group outreach 

event).

Reported once 

across the duration 

of the programs 

(the period of performance for 

HRSA–21–136 is 6 

months, and for 

HRSA–21–140 is 

12 months).

Sampled response 

times of approximately 6 minutes 

per response.

Total hours spent on 

responses for all 

funded organizations over a 2-year 

period. 

3,000 (est.) ............... 4,000,000 (est.) ........ 1 ............................... 4,000,000 ................. 0.12 hours ................ 466,667. 

General outreach activities for community members form.Number of community outreach workers deployed for 6 

months (HRSA– 

21–136) or 12 

months (HRSA– 

21–140) of support.

Number of community members in 

contact with community outreach 

workers.

One response per 

respondent or less 

(e.g., one response from the 

audience of a 

group outreach 

event).

Reported once 

across the duration 

of the programs 

(the period of performance for 

HRSA–21–136 is 6 

months, and for 

HRSA–21–140 is 

12 months).

Sampled response 

times of approximately 6 minutes 

per response.

Total hours spent on 

responses for all 

funded organizations over a 2-year 

period. 

3,000 (est.) ............... 4,000,000 (est.) ........ 1 ............................... 4,000,000 ................. 0.12 hours ................ 466,667. 

Grand Total ......... 8,003,000 (est.) ........ .................................. .................................. 8,003,000 (est.) ........ .................................. 934,134. 

HRSA specifically requests comments 

on (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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–17495 Filed 8–13–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0430, 0431, 

0432, 0433, 0434] 

Agency Information Collection 

Request; 60-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 proposed 

extensions of collections for public 

comment. 

DATES: Comments on the ICR must be 

received on or before October 15, 2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–New–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

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. 


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