Notice2021-15646
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport; Extension of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 15, 2021. In the notice, FDA requested comments by August 16, 2021. The Agency is taking this action in response to a correction to the notice's docket number that appeared in the Federal Register of June 30, 2021, to allow interested persons time to submit comments in response to the corrected notice.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39047-39048]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15646]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0424]
Medical Devices; Exemption From Premarket Notification: Powered
Patient Transport, All Other Powered Patient Transport; Extension of
Comment Period
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice that appeared in the
Federal Register of June 15, 2021. In the notice, FDA requested
comments by August 16, 2021. The Agency is taking this action in
response to a correction to the notice's docket number that appeared in
the Federal Register of June 30, 2021, to allow interested persons time
to submit comments in response to the corrected notice.
DATES: FDA is extending the comment period on the notice published June
15, 2021 (86 FR 31722). Submit either electronic or written comments by
August 30, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 30, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
[[Page 39048]]
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 30, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-P-0424 for ``Medical Devices; Exemption from Premarket
Notification: Powered Patient Transport, All Other Powered Patient
Transport.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993-0002, 240-402-4717.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 15, 2021,
FDA published a notice with a 60-day comment period requesting comments
by August 16, 2021. Comments on the notice will inform FDA's response
to a petition requesting exemption from premarket notification
requirements for powered patient transport, all other powered patient
transport.
In the Federal Register of June 30, 2021, FDA corrected the docket
number associated with the notice (86 FR 34770). FDA has considered the
requirements associated with receipt of a petition requesting exemption
from premarket notification requirements under section 510(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)). Due to the
correction to the docket number, the Agency is extending the comment
period for the notice, until August 30, 2021. The Agency believes that
an extension allows adequate time for interested persons to submit
comments from the date of the correction to the notice issued June 30,
2021, without delaying our consideration of these important issues.
Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15646 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P
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