11304 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) .............................................. 62 1 62 2 124 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification of emergency use—814.124(a) ........................ 22 1 22 1 22 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents in tables 

1, 2, and 3 are an average based on data 

for the previous 3 years, i.e., fiscal years 

2017 through 2019. The number of 

respondents has been adjusted to reflect 

updated respondent data. This has 

resulted in an overall increase of 5,803 

hours to the total estimated burden. The 

number of annual reports submitted 

under § 814.126(b)(1) in table 1 reflects 

50 respondents with approved HUD 

applications. Based on further review, 

the estimated number of recordkeepers 

has been adjusted from 65 respondents 

to 62 respondents in table 2 to reflect 

the most current data available. 

Therefore, under § 814.126(b)(2) in table 

2, the estimated number of 

recordkeepers is 62. 

We have also updated the burden 

estimate consistent with new provisions 

in § 814.104(b)(4)(i) regarding ‘‘Human 

Subject Protection; Acceptance of Data 

from Clinical Investigations for Medical 

Devices’’ (83 FR 7366; February 21, 

2018) (approved under OMB control 

number 0910–0741). Section 814.104 is 

being amended to address submission of 

data from clinical investigations in an 

HDE. To the extent the applicant 

includes data from clinical 

investigations, the applicant will be 

required to include the information and 

statements as described in 

§ 814.104(b)(4)(i). Consistent with our 

estimate in OMB control number 0910– 

0741, this revision increases our burden 

estimate for an HDE by 8 hours per 

submission. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03746 Filed 2–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Information Collection 

Request Title: Rural Health Clinic 

COVID–19 Testing Program Data 

Collection, OMB No. 0906–0056— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than March 26, 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 Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Rural Health Clinic COVID–19 Testing 

Program Data Collection, OMB No. 

0906–0056—Extension. 

Abstract: This ICR is for continued 

approval of the Rural Health Clinic 

(RHC) COVID–19 Testing Program Data 

Collection. HRSA is proposing to 

continue this data collection with no 

changes. The current performance 

measures are collected electronically in 

the RHC COVID–19 Testing Report 

(CTR), which funded providers access 

via rhccovidreporting.com. RHC 

COVID–19 Testing Program Data 

Collection supports the HRSA 

requirement to monitor and report on 

funds distributed under the Paycheck 

Protection Program and Health Care 

Enhancement Act. Signed into law on 

April 24, 2020, the Paycheck Protection 

Program and Health Care Enhancement 

Act appropriated $225 million to RHCs 

to support COVID–19 testing efforts, 

expand access to testing in rural 

communities, and other related 

expenses. On May 20, 2020, HRSA 

issued funding as one-time payments to 

2,406 RHC organizations based on the 

number of certified clinic sites they 

operate, providing $49,461.42 per clinic 

site (4,549 RHC clinic sites total across 

the country). 

The RHC CTR collects monthly, 

aggregate data from funded 

organizations. Funded organizations 

provide basic identifying information, 

report on the number of and location of 

testing sites, indicate how they used the 

funds, and report the total number of 

patients tested and the number of tests 

with a positive result. 

Funded organizations must report the 

number of patients tested and the 

number of positive tests on a monthly 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 11305 

basis for the duration of the reporting 

period. HRSA will use this information 

to evaluate the effectiveness of COVID– 

19 Testing Program at an aggregate level, 

assist HRSA in understanding how RHC 

COVID–19 Testing Program funding is 

being used to support RHC 

organizations and patients, and ensure 

that HRSA is compliant with federal 

reporting requirements. 

A 60-day notice published in the 

Federal Register on December 10, 2020, 

vol. 85, No. 238; p. 79492. There were 

no public comments. 

Need and Proposed Use of the 

Information: The RHC CTR is designed 

to collect information from funded 

providers who use RHC COVID–19 

Testing Program funding to support 

COVID–19 testing efforts, expand access 

to testing in rural communities, and 

other related expenses. These data are 

critical to meet HRSA requirements to 

monitor and report on how federal 

funding is being used and to measure 

the effectiveness of RHC CTR. 

Specifically, these data will be used to 

assess the following: 

• Whether program funds are being 

spent for their intended purposes; 

• Where COVID–19 testing supported 

by these funds is occurring; 

• Number of patients tested for 

COVID–19; and 

• Results of provided COVID–19 

tests. 

Likely Respondents: Respondents are 

RHC organizations who received 

funding for COVID–19 testing and 

related expenses. 

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 

RHC COVID–19 Testing Report .......................................... 2,406 12 28,872 .25 7,218 

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. 2021–03749 Filed 2–23–21; 8:45 am] 

BILLING CODE 4165–15–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: Small Health 

Care Provider Quality Improvement 

Program, OMB No. 0915–0387— 

Extension 

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 the proposed data 

collection projects of the Paperwork 

Reduction Act of 1995, HRSA 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 April 26, 2021. 

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 

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 request collection title for 

reference. 

Information Collection Request Title: 

Small Health Care Provider Quality 

Improvement Program, OMB No. 0915– 

0387—Extension. 

Abstract: This program is authorized 

by Title III, Public Health Service Act, 

Section 330A(g) (42 U.S.C. 254c(g)), as 

amended. This authority authorizes 

HRSA’s Federal Office of Rural Health 

Policy to issue grants that expand access 

to, coordinate, contain the cost of, and 

improve the quality of essential health 

care services, including preventive and 

emergency services, through the 

development of health care networks in 

rural and frontier areas and regions. 

Across these various programs, the 

authority allows HRSA to provide funds 

to rural communities to support the 

direct delivery of health care and related 

services, expand existing services, or 

enhance health service delivery through 

education, promotion, and prevention 

programs. 

The purpose of the Small Health Care 

Provider Quality Improvement Grant 

(Rural Quality) Program is to provide 

support to rural primary care providers 

for implementation of quality 

improvement activities. The goal of the 

program is to promote the development 

of an evidence-based culture and 

delivery of coordinated care in the 

primary care setting. Additional 

objectives of the program include 

improved health outcomes for patients, 

enhanced chronic disease management, 

and better engagement of patients and 

their caregivers. Organizations 

participating in the program are 

required to use an evidence-based 

quality improvement model, perform 

tests of change focused on 

improvement, and use health 


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