Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20441 

and reporting to conduct an assessment 

of current methodologies and data/ 

metrics available to represent the 

MDUFA workforce. Additional details 

regarding the independent assessments 

can be found in Section VI of the 

proposed commitment letter. 

P. Performance Reports 

FDA proposes to continue to report 

quarterly and annually on performance 

against commitments. Additionally, 

FDA proposes to report quarterly on 

progress toward hiring goals and 

funding intended for RWE activities. 

FDA will report annually on the 

primary cost drivers for changes to 

personnel compensation and benefits 

costs. Additional details regarding 

performance reporting can be found in 

Section VII of the proposed commitment 

letter. 

Q. User Fee Revenue and Fee 

Allocations 

As part of MDUFA V, FDA and 

industry propose updating the base fee 

amounts for PMAs and annual 

establishment registrations, as well as 

the annual total revenue amounts, to 

reflect negotiated fee levels. The 

statutory total revenue amounts, base 

fee amounts, and amounts for potential 

performance improvement adjustments 

are proposed in FY 2021 dollars, such 

that annual inflation adjustments will 

be used to inflate FY 2021 dollars to the 

appropriate amounts for each fiscal year 

in MDUFA V. FDA and industry also 

propose to change the fee for a PMA 

Panel-Track supplement from 75 

percent to 80 percent of the fee for an 

original PMA and to change the fee for 

a 510(k) submission from 3.4 percent to 

4.5 percent of the fee for a PMA. Finally, 

a minor change is proposed to the 

statutory provisions regarding fee 

waivers and reductions for small 

businesses to clarify that an applicant 

seeking a waiver or reduction is not 

required to submit a certification from 

the national taxing authority of the 

foreign country in which the applicant, 

or its affiliate, is located, if the country 

has no national taxing authority. 

FDA will post the agenda 

approximately 5 days before the meeting 

at: https://www.fda.gov/medicaldevices/workshops-conferencesmedical-devices/public-meetingmedical-device-user-fee-amendmentsfiscal-years-2023-through-2027- 

04192022. 

IV. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit https://

www.fda.gov/medical-devices/ 

workshops-conferences-medicaldevices/public-meeting-medical-deviceuser-fee-amendments-fiscal-years-2023- 

through-2027-04192022. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, email, and telephone 

number. Registrants will receive 

confirmation after they have been 

accepted. 

Registration is free. Persons interested 

in attending by webcast the MDUFA 

virtual public meeting must register 

online by 4 p.m. Eastern Time, April 18, 

2022. Early registration is 

recommended. 

If you need special accommodations 

because of a disability, please contact 

Susan Monahan at 240–205–2260 or 

Susan.Monahan@fda.hhs.gov no later 

than April 11, 2022. 

Requests for Oral Presentations: This 

meeting includes a public comment 

session and topic-focused sessions. 

During online registration you may 

indicate if you wish to present during 

the public comment session or a specific 

session, and which topic(s) you wish to 

address. All requests to make oral 

presentations virtually by webcast must 

be received by April 11, 2022, at 4 p.m. 

Eastern Time. FDA will do its best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations and request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin and 

will notify speakers by April 12, 2022. 

If selected for presentation, any 

presentation materials must be emailed 

to Mimi Nguyen (see FOR FURTHER

INFORMATION CONTACT) no later than 

April 13, 2022, at 4 p.m.. Eastern Time. 

No commercial or promotional material 

will be permitted to be presented or 

distributed at the meeting. 

FDA is holding this meeting to 

provide information on the proposed 

recommendations for the 

reauthorization of MDUFA for FYs 2023 

through 2027. To permit the widest 

possible opportunity to obtain public 

comment, FDA is soliciting either 

electronic or written comments on all 

aspects of the meeting topics. The 

docket was opened on March 22, 2022. 

The proposed commitment letter was 

posted in the docket and on this website 

at: https://www.fda.gov/industry/ 

medical-device-user-fee-amendmentsmdufa/medical-device-user-feeamendments-2023-mdufa-v. The docket 

will close on April 21, 2022, 30 days 

after the proposed commitment letter 

was posted. 

Streaming Webcast of the Public 

Meeting: The webcast link will be 

available on the registration web page 

after April 11, 2022. Organizations are 

requested to register all participants. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at in the docket at https:// 

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available approximately 45 days 

after the public workshop on the 

internet at: https://www.fda.gov/ 

medical-devices/workshopsconferences-medical-devices/publicmeeting-medical-device-user-feeamendments-fiscal-years-2023-through2027-04192022. 

Dated: April 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07451 Filed 4–6–22; 8:45 am] 

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; COVID–19 Provider 

Relief Fund (PRF) and American 

Rescue Plan (ARP) Rural Payment 

Reporting Activities, OMB No. 0906– 

0068—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: 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 June 6, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail 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 


khammond on DSKJM1Z7X2PROD with NOTICES
20442 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the HRSA 

Acting Information Collection Clearance 

Officer at (240) 276–7189. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

COVID–19 Provider Relief Fund (PRF) 

Reporting Activities OMB No. 0906– 

0068—Revision. 

Abstract: HRSA disburses the PRF 

and ARP Rural payments to eligible 

health care providers to support health 

care-related expenses or lost revenues 

attributable to the COVID–19 pandemic. 

Providers who have attested to the 

Terms & Conditions (T&Cs) regarding 

their PRF and ARP Rural payment(s), 

including the requirement that the 

provider ‘‘shall submit reports as the 

Secretary determines are needed to 

ensure compliance with conditions that 

are imposed on this Payment, and such 

reports shall be in such form, with such 

content, as specified by the Secretary in 

future program instructions directed to 

all recipients,’’ will be using the PRF 

Reporting Portal to submit information 

about their use of PRF and ARP Rural 

payments. In anticipation of the 

approved OMB form (control number 

0906–0068) expiring on January 31, 

2023, HRSA is undergoing the revision 

of the ICR approval to include the ARP 

Rural reporting requirements and to 

allow for data collection beyond the 

January 31, 2023, expiration. 

Need and Proposed Use of the 

Information: Recipients of a PRF and 

ARP Rural payment agreed to a set of 

T&Cs, which, among other 

requirements, mandate compliance with 

certain reporting requirements that will 

facilitate appropriate oversight of 

recipients’ use of funds. 

Information collected will allow for 

(1) assessing whether recipients have 

met statutory and programmatic 

requirements, (2) conducting audits, (3) 

gathering data required to report on 

findings with respect to the 

disbursements of PRF and ARP Rural 

payments, and (4) program evaluation. 

HRSA staff will also use information 

collected to identify and report on 

trends in health care metrics and 

expenditures before and during the 

allowable period for expending PRF and 

ARP Rural payments. 

Likely Respondents: PRF and ARP 

Rural payment recipients who have 

received more than $10,000 in aggregate 

PRF and ARP Rural payments during 

one of the Payment Received Periods 

outlined below and that agreed to the 

associated T&Cs are required to submit 

a report in the PRF Reporting Portal 

during the applicable Reporting Time 

Period. 

Reporting period 

Payment received period 

(payments exceeding $10,000 in 

aggregate received) 

Reporting time period 

Period 1 ................................ April 10, 2020, to June 30, 2020 .................................... July 1, 2021, to September 30, 2021. 

Period 2 ................................ July 1, 2020, to December 31, 2020 .............................. January 1, 2022, to March 31, 2022. 

Period 3 ................................ January 1, 2021, to June 30, 2021 ................................. July 1, 2022, to September 30, 2022. 

Period 4 ................................ July 1, 2021, to December 31, 2021 .............................. January 1, 2023, to March 31, 2023. 

Period 5 ................................ January 1, 2022, to June 30, 2022 ................................. July 1, 2023, to September 30, 2023. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

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 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

PRF Reporting Portal, Reporting Period 1 (Providers who received payments April 10, 

2020, to June 30, 2020) ................................................................................................ 126,831 1 126,831 5.6 710,254 

PRF Reporting Portal, Reporting Period 2 (Providers who received payments July 1, 

2020, to December 31, 2020) ....................................................................................... 120,536 1 120,536 4.2 506,251 

PRF Reporting Portal, Reporting Period 3 (Providers who received payments, January 

1, 2021, to June 30, 2021) ............................................................................................ 20,493 1 20,493 6.1 125,565 

PRF and ARP Rural Reporting Portal, Reporting Period 4 (Providers who received 

payments July 1, 2021, to December 31, 2021) ........................................................... 51,622 1 51,622 5.6 287,514 

PRF and ARP Rural Reporting Portal, Reporting Period 5 (Providers who received 

payments January 1, 2022, to June 30, 2022) ............................................................. 4,256 1 4,256 5.5 23,288 

Total ........................................................................................................................... 323,738 ........................ 323,738 .................... 1,652,872 

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. 2022–07408 Filed 4–6–22; 8:45 am] 

BILLING CODE 4165–15–P 


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