45738 Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices 

transfer fee, especially for international 

wire transfers. Applicable wire transfer 

fees must be included with payment to 

ensure fees are paid in full. Questions 

about wire transfer fees should be 

addressed to the financial institution. 

The account information for wire 

transfers is as follows: U.S. Department 

of the Treasury, TREAS NYC, 33 Liberty 

St., New York, NY 10045, Acct. No.: 

75060099, Routing No.: 021030004, 

SWIFT: FRNYUS33. If needed, FDA’s 

tax identification number is 53– 

0196965. 

B. Prescription Drug Program Fees 

FDA will issue invoices and payment 

instructions for FY 2022 program fees 

under the new fee schedule in August 

2021. Payment will be due on October 

1, 2021. FDA will issue invoices in 

December 2021 for products that qualify 

for FY 2022 program fee assessments 

after the August 2021 billing. 

Dated: August 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17505 Filed 8–13–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0739] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; 4F–MDMB–BICA (4F– 

MDMB–BUTICA); Brorphine; 

Metonitazene; Eutylone (bk-EBDB); 

BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom 

(mitragynine, 7-hydroxymitragynine); 

Phenibut; Reopening Comment Period 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; reopening comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

reopening the comment period for the 

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 

appeared in the Federal Register of July 

23, 2021. The Agency is taking this 

action to allow interested persons 

additional time to submit comments. 

These comments will be considered in 

preparing a response from the United 

States to the World Health Organization 

(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. 

DATES: FDA is reopening the comment 

period for the notice published July 23, 

2021 (86 FR 39038). Submit either 

electronic or written comments by 

August 24, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 24, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 24, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

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–0739 for ‘‘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; 

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.’’ The 

Agency 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 to 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 this 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 


lotter on DSK11XQN23PROD with NOTICES1
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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