[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77220-77221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1845]


Fixed-Quantity Unit-of-Use Blister Packaging for Certain 
Immediate-Release Opioid Analgesics for Treatment of Acute Pain; 
Establishment of a Public Docket; Request for Comments; Reopening of 
the Comment Period and Provision of Additional Information and Analysis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for and providing additional information 
and analysis regarding the notice entitled ``Fixed-Quantity Unit-of-Use 
Blister Packaging for Certain Immediate-Release Opioid Analgesics for 
Treatment of Acute Pain; Establishment of a Public Docket; Request for 
Comments'' that appeared in the Federal Register of May 31, 2019. The 
Agency is taking this action to provide additional information and to 
allow

[[Page 77221]]

interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice published on 
May 31, 2019 (84 FR 25283). Submit either electronic or written 
comments on the notice by February 1, 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 February 1, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 1, 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-2019-N-1845 for ``Fixed-Quantity Unit-of-Use Blister Packaging for 
Certain Immediate-Release Opioid Analgesics for Treatment of Acute 
Pain.'' 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: Patrick Raulerson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993, 301-796-
3522, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of May 31, 2019 (84 
FR 25283), FDA published a notice entitled ``Fixed-Quantity Unit-of-Use 
Blister Packaging for Certain Immediate-Release Opioid Analgesics for 
Treatment of Acute Pain; Establishment of a Public Docket; Request for 
Comments'' with a 60-day comment period. The notice described a 
potential modification to the Opioid Analgesic Risk Evaluation and 
Mitigation Strategy (REMS) to require that certain solid, oral dosage 
forms of immediate-release opioid analgesics commonly prescribed for 
treatment of acute pain be made available in fixed-quantity unit-of-use 
blister packaging for outpatient dispensing. The intent would be to 
reduce the amount of unused opioid analgesics, thereby reducing 
opportunities for misuse, abuse, inappropriate access, and overdose, 
and possibly reducing the development of new opioid addiction. 
Prescribers would continue to exercise their clinical judgement to 
prescribe opioid analgesics in the quantity appropriate for a given 
patient. That is, the blister packaging configurations under 
consideration would not be required to be the only packaging option 
available for these products.
    Following an initial review of comments received, FDA held a series 
of listening sessions with stakeholders, which included an FDA slide 
presentation containing additional information and analysis regarding 
this potential REMS modification. FDA is now reopening the comment 
period to obtain additional written comments from stakeholders and to 
add to the docket this slide presentation. The comment period will be 
open until February 1, 2021. The Agency believes that an additional 60 
days will allow adequate time for interested persons to submit 
comments.

    Dated: November 24, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26504 Filed 11-30-20; 8:45 am]
BILLING CODE 4164-01-P