69586 Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Rules and Regulations 

falling out of the device, and 

insufficient mechanical strength of the 

device and stair-climbing mechanism. 

D. Any Changes to the Device Would 

Not Be Likely to Result in a Change in 

the Device’s Classification 

Lastly, the petition states that any 

changes to the devices would not be 

likely to result in a change in the 

device’s classification. Specifically, the 

petition states that the ‘‘device has been 

on the market for several decades and is 

well characterized and understood by 

manufacturers and healthcare 

professionals.’’ The petition then cites 

to section 513(g) of the FD&C Act as a 

mechanism to obtain the Agency’s 

views about the classification and 

applicable regulatory requirements for a 

device that has been significantly 

changed. As noted above, FDA does not 

agree with petitioner that the subject 

devices are well characterized at this 

time, thus we cannot foresee whether, or 

what, changes will result in the devices’ 

classification. While FDA agrees that 

section 513(g) is an appropriate 

mechanism to obtain the Agency’s 

views about the classification and 

applicable regulatory requirements of a 

device, the mere fact that such an 

optional feedback mechanism exists 

may only contribute to, but would not 

guarantee, the reasonable assurance of 

safety and effectiveness of any 

particular device. Additionally, because 

FDA believes that a change to the device 

would be likely to result in a change in 

classification, FDA did not evaluate 

petitioner’s contention that the 

limitations on exemption under 21 CFR 

890.9 would apply to any changes that 

do not result in a change in 

classification. Thus, the petitioner’s 

response to this factor does not weigh in 

favor of exemption from the 

requirements of premarket notification. 

For all the foregoing reasons, the 

petition failed to demonstrate that 

premarket notification is not necessary 

to provide reasonable assurance of 

safety and effectiveness for the subject 

device type. Therefore, FDA denied the 

petition request for exemption from 

premarket notification requirements for 

powered patient transport, all other 

powered patient transport, and is 

issuing this order setting forth the final 

determination. Manufacturers of this 

device type must continue to submit 

and receive FDA clearance of a 510(k) 

submission before marketing their 

device, as well as comply with all other 

applicable requirements under the 

FD&C Act. 

V. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. Paperwork Reduction Act of 1995 

While this final order contains no 

new collection of information, it does 

refer to previously approved FDA 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521) is not required for this final order. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 820, 

regarding quality system regulation, 

have been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR part 807, subpart 

E, regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; and 

the collections of information in 21 CFR 

parts 800, 801, and 809, regarding 

labeling, have been approved under 

OMB control number 0910–0485. 

Dated: December 3, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–26636 Filed 12–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Parts 1910, 1915, 1917, 1918, 

1926, and 1928 

[Docket No. OSHA–2021–0007] 

RIN 1218–AD42 

COVID–19 Vaccination and Testing; 

Emergency Temporary Standard 

Correction 

In rule document 2021–26268, 

appearing on page 68560 in the issue of 

Friday, December 3, 2021, make the 

following correction: 

On page 68560, in the first column, in 

the DATES section, on the third and 

fourth lines, ‘‘86 FR 6140’’ should read, 

‘‘86 FR 61402’’. 

[FR Doc. C1–2021–26268 Filed 12–7–21; 8:45 am] 

BILLING CODE 0099–10–D 

NATIONAL FOUNDATION ON THE 

ARTS AND HUMANITIES 

National Endowment for the 

Humanities 

45 CFR Part 1177 

RIN 3136–AA38 

Claims Collection; Correction 

AGENCY: National Endowment for the 

Humanities; National Foundation on the 

Arts and the Humanities. 

ACTION: Direct final rule; correction. 

SUMMARY: The National Endowment for 

the Humanities (NEH) is correcting a 

direct final rule that published 

November 24, 2021, in the Federal 

Register. The final rule revised the NEH 

Claims Collection regulation in 

accordance with the Debt Collection 

Improvement Act of 1996 (DCIA), as 

implemented by the Department of 

Justice (DOJ) and the Department of 

Treasury (Treasury) in the revised 

Federal Claims Collection Standards 

(FCCS). NEH discovered two errors after 

publications that could cause confusion 

and is correcting those errors in this 

document. 

DATES: Effective February 22, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Voyatzis, Deputy General 

Counsel, Office of the General Counsel, 

National Endowment for the 

Humanities, 400 7th Street SW, Room 

4060, Washington, DC 20506; (202) 606– 

8322; gencounsel@neh.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2021–23742, appearing in the Federal 

Register of November 24, 2021, starting 

on page 66964, make the following 

corrections: 

§ 1177.9 [Corrected] 

■ 1. On page 66967, in the second 

column, designate the second paragraph 

(e) as paragraph (f). 

§ 1177.24 [Corrected] 

■ 2. On page 66973 in the first column, 

correct the paragraph designations ‘‘a.’’ 

and ‘‘b.’’ to read as ‘‘(a)’’ and ‘‘(b)’’. 

Authority: 31 U.S.C. 3711, 3716–3719; 

Pub. L. 104–134; 31 CFR 900–904. 

Dated: December 3, 2021. 

Samuel Roth, 

Attorney-Advisor, National Endowment for 

the Humanities. 

[FR Doc. 2021–26606 Filed 12–7–21; 8:45 am] 

BILLING CODE 7536–01–P 


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