[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