Claims Collection; Correction, 69586 [2021-26606]
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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.
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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.
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16:00 Dec 07, 2021
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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]
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DEPARTMENT OF LABOR
NATIONAL FOUNDATION ON THE
ARTS AND HUMANITIES
National Endowment for the
Humanities
45 CFR Part 1177
RIN 3136–AA38
Claims Collection; Correction
National Endowment for the
Humanities; National Foundation on the
Arts and the Humanities.
AGENCY:
ACTION:
Direct final rule; correction.
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.
SUMMARY:
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.
In FR Doc.
2021–23742, appearing in the Federal
Register of November 24, 2021, starting
on page 66964, make the following
corrections:
SUPPLEMENTARY INFORMATION:
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, 1917, 1918,
1926, and 1928
[Docket No. OSHA–2021–0007]
§ 1177.9
[Corrected]
RIN 1218–AD42
1. On page 66967, in the second
column, designate the second paragraph
(e) as paragraph (f).
COVID–19 Vaccination and Testing;
Emergency Temporary Standard
§ 1177.24
■
[Corrected]
2. On page 66973 in the first column,
correct the paragraph designations ‘‘a.’’
and ‘‘b.’’ to read as ‘‘(a)’’ and ‘‘(b)’’.
■
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’’.
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. C1–2021–26268 Filed 12–7–21; 8:45 am]
[FR Doc. 2021–26606 Filed 12–7–21; 8:45 am]
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[Federal Register Volume 86, Number 233 (Wednesday, December 8, 2021)]
[Rules and Regulations]
[Page 69586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26606]
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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; [email protected].
SUPPLEMENTARY INFORMATION: In FR Doc. 2021-23742, appearing in the
Federal Register of November 24, 2021, starting on page 66964, make the
following corrections:
Sec. 1177.9 [Corrected]
0
1. On page 66967, in the second column, designate the second paragraph
(e) as paragraph (f).
Sec. 1177.24 [Corrected]
0
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]
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