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, 77220-77221 [2020-26504]

Download as PDF 77220 Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices and include information collection provisions. Part 58 requires testing facilities engaged in conducting toxicological studies to retain, and make available to regulatory officials, records regarding compliance with GLPs. Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. The GLP regulations require that, for each nonclinical laboratory study, a final report be prepared that documents the results of quality assurance unit inspections, test and control article characterization, testing of mixtures of test and control articles with carriers, and an overall interpretation of nonclinical laboratory studies. The GLP regulations also require written records pertaining to: (1) Personnel job descriptions and summaries of training and experience; (2) master schedules, protocols and amendments thereto, inspection reports, and SOPs; (3) equipment inspection, maintenance, calibration, and testing records; (4) documentation of feed and water analyses and animal treatments; (5) test article accountability records; and (6) study documentation and raw data. In the Federal Register of July 24, 2020 (85 FR 44900), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received that encouraged implementation of automated collection methods and analytical software to evaluate results. FDA appreciates this comment and continually seek ways to employ efficient collection methods using our limited resources. The comment suggested no revision to our burden estimate. FDA estimates the burden of this information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR part Number of responses per respondent Average burden per response Total annual responses Total hours 58.35(b)(7); Quality assurance unit ................................ 58.185; Reporting of nonclinical laboratory study results 300 300 60.25 60.25 18,075 18,075 1 27.65 18,075 499,774 Total ......................................................................... ........................ .......................... ........................ ........................... 517,849 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR part Average burden per recordkeeping Total annual records Total hours 58.29(b); Personnel .......................................................... 58.35(b)(1)–(6) and (c); Quality assurance unit ............... 58.63(b) and (c); Maintenance and calibration of equipment. 58.81(a)–(c); SOPs ........................................................... 58.90(c) and (g); Animal care ........................................... 58.105(a) and (b); Test and control article characterization. 58.107(d); Test and control article handling ..................... 58.113(a); Mixtures of articles with carriers ..................... 58.120; Protocol ................................................................ 58.195; Retention of records ............................................ 300 300 300 20 270.76 60 6,000 81,228 18,000 .21 (13 minutes) 3.36 .................. .09 (5 minutes) 1,260 272,926 1,620 300 300 300 301.80 62.70 5 90,540 18,810 1,500 .14 (8 minutes) .13 (8 minutes) 11.8 .................. 12,676 2,445 17,700 300 300 300 300 1 15.33 15.38 251.50 300 4,599 4,614 75,450 4.25 .................. 6.8 .................... 32.7 .................. 3.9 .................... 1,275 31,273 150,878 294,255 Total ........................................................................... ........................ ........................ ........................ ........................... 786,308 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, FDA has made no adjustments to our burden estimate. Dated: November 24, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. khammond on DSKJM1Z7X2PROD with NOTICES4 Number of records per recordkeeper [FR Doc. 2020–26502 Filed 11–30–20; 8:45 am] BILLING CODE 4164–01–P ACTION: Food and Drug Administration SUMMARY: [Docket No. FDA–2019–N–1845] Fixed-Quantity Unit-of-Use Blister Packaging for Certain ImmediateRelease 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. VerDate Sep<11>2014 18:11 Nov 30, 2020 Jkt 253001 Notice; reopening of the comment period. DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 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 ImmediateRelease 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 E:\FR\FM\01DEN1.SGM 01DEN1 Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices 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’’). khammond on DSKJM1Z7X2PROD with NOTICES4 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 VerDate Sep<11>2014 18:11 Nov 30, 2020 Jkt 253001 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 Unitof-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-201509-18/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 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 77221 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, Patrick.Raulerson@fda.hhs.gov. 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 ImmediateRelease 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 E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

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