Document ID: FDA-2021-N-0862-0140
Agency: fda
Document Type: Proposed Rule
Title: Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period
Posted Date: 2022-10-24T04:00Z

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Proposed Rules]
[Pages 64178-64179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23033]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 314

[Docket No. FDA-2021-N-0862]
RIN 0910-AH62

Nonprescription Drug Product With an Additional Condition for 
Nonprescription Use; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; 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 proposed rule that appeared in the 
Federal Register of June 28, 2022. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published on June 28, 2022 (87 FR 38313). Either electronic or written 
comments must be submitted by November 25, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 25, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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-0862 for ``Nonprescription Drug Product With an Additional 
Condition for Nonprescription Use.'' 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: Chris Wheeler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993-0002, 301-
796-0151, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 28, 2022, 
FDA published a proposed rule entitled ``Nonprescription Drug Product 
With an Additional Condition for Nonprescription Use.'' The 120-day 
comment period for the proposed rule is scheduled to close on October 
26, 2022. The proposed rule, if finalized, would establish requirements 
for a nonprescription drug product that has an additional condition for 
nonprescription use that an applicant must implement to ensure 
appropriate self-selection or appropriate actual use, or both, by 
consumers without the supervision of a healthcare practitioner.
    The Agency has received separate requests for a 30-day and 90-day

[[Page 64179]]

extension of the comment period for the proposed rule. Each request 
conveyed concern that the current 120-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule until November 25, 2022. The Agency believes that 
this extension allows adequate time for interested persons to submit 
comments without significantly delaying rulemaking on these important 
issues.

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23033 Filed 10-20-22; 8:45 am]
BILLING CODE 4164-01-P