Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 11303 

2. Modeling natural history of disease, 

specifically methodological 

considerations and challenges in 

characterizing the natural relationship 

between pharmacodynamic markers and 

clinical outcomes. 

3. Clinical trial simulations based on 

disease progression/natural history 

models to support drug development 

and regulatory decisions. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03727 Filed 2–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4951] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 26, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The OMB 

control number for this information 

collection is 0910–0332. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices; Humanitarian Use 

Devices—21 CFR Part 814 

OMB Control Number 0910–0332— 

Extension 

This collection of information 

implements the humanitarian use 

devices (HUDs) provision of section 

520(m) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(m)) and part 814, subpart H (21 

CFR part 814, subpart H). Under section 

520(m) of the FD&C Act, FDA is 

authorized to exempt an HUD from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act (21 U.S.C. 

360d and 360e) provided that the 

device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 

account the probable risks and benefits 

of currently available devices or 

alternative forms of treatment. 

Respondents may submit a 

humanitarian device exemption (HDE) 

application seeking exemption from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act as 

authorized by section 520(m)(2) of the 

FD&C Act. The information collected 

will assist FDA in making 

determinations on the following: (1) 

Whether to grant HUD designation of a 

medical device; (2) whether to exempt 

an HUD from the effectiveness 

requirements under sections 514 and 

515 of the FD&C Act, provided that the 

device meets requirements set forth 

under section 520(m) of the FD&C Act; 

and (3) whether to grant marketing 

approval(s) for the HUD. Failure to 

collect this information would prevent 

FDA from making a determination on 

the factors listed previously in this 

document. Further, the collected 

information would also enable FDA to 

determine whether the holder of an 

HUD is in compliance with the HUD 

provisions under section 520(m) of the 

FD&C Act. 

In the Federal Register of August 13, 

2020 (85 FR 49379), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although two comments 

were received, they were not responsive 

to the four collection of information 

topics solicited. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for HUD designation—814.102 ............................. 20 1 20 40 800 

HDE Application—814.104 .................................................. 4 1 4 328 1,312 

HDE Amendments and resubmitted HDEs—814.106 ......... 20 5 100 50 5,000 

HDE Supplements—814.108 ............................................... 116 1 116 80 9,280 

Notification of withdrawal of an HDE—814.116(e)(3) ......... 2 1 2 1 2 

Notification of withdrawal of institutional review board approval—814.124(b) ........................................................... 1 1 1 2 2 

Periodic reports—814.126(b)(1) .......................................... 50 1 50 120 6,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,396 

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


khammond on DSKJM1Z7X2PROD with NOTICES
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