Document ID: FDA-2021-P-0424-0005
Agency: fda
Document Type: Notice
Title: Medical Devices; Exemption From Premarket Notification: Powered 
Patient Transport, All Other Powered Patient Transport; Extension of 
Comment Period
Posted Date: 2021-07-23T04:00Z

[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39047-39048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov

[[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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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