[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54455-54456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0843]


Genus Medical Technologies LLC Versus Food and Drug 
Administration; Request for Information and Comments; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments; 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 entitled ``Genus Medical 
Technologies LLC Versus Food and Drug Administration; Request for 
Information and Comments'' that appeared in the Federal Register of 
August 9, 2021. The Agency is taking this action to allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period for the notice published on 
August 9, 2021 (86 FR 43553). Submit either electronic or written 
comments by November 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 November 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 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-N-0843 for ``Genus Medical Technologies LLC Versus Food and 
Drug Administration; Request for Information and Comments.'' 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

[[Page 54456]]

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: Alexandra Lucas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-0230, 
Drug_Device_Transition_Inquiry@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 9, 2021 
(86 FR 43553), FDA published a notice announcing that implementation of 
a decision from the U.S. Court of Appeals for the District of Columbia 
Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. app. Lexis 10928 
(April 16, 2021) is expected to require some approved products to 
transition from drug status to device status. That notice provides a 
60-day comment period and solicits public comment to inform the 
Agency's deliberations about products potentially impacted by the Genus 
decision and the way in which impacted products should be transitioned 
from drug to device status.
    FDA is extending the comment period until November 30, 2021, based 
on requests FDA received from relevant stakeholders. The Agency 
believes that an additional 60 days will allow adequate time for 
interested persons to submit comments to inform the Agency's 
implementation of the Genus decision.

    Dated: September 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21403 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P


