[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20172-20174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0275]


Morphine Milligram Equivalents: Current Applications and 
Knowledge Gaps, Research Opportunities, and Future Directions; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the following public workshop entitled ``Morphine Milligram 
Equivalents: Current Applications and Knowledge Gaps, Research 
Opportunities, and Future Directions.'' The purpose of the workshop is 
to bring stakeholders together to discuss the scientific basis of 
morphine milligram equivalents (MMEs) with the goals of providing an 
understanding of the science and data underlying existing MME 
calculations for opioid analgesics, discussing the gaps in these data, 
and discussing future directions to refine and improve the scientific 
basis of MME applications.

DATES: The public workshop will be held virtually and via webcast on 
June 7 and 8, 2021, from 9 a.m. to 5 p.m. Eastern Time each day. Submit 
either electronic or written comments on this public workshop by August 
9, 2021. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this public workshop via an 
online teleconferencing platform.
    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 August 9, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of August 9, 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:

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     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-0275 for ``Morphine Milligram Equivalents: Current 
Applications and Knowledge Gaps, Research Opportunities, and Future 
Directions; Public Workshop; Request for 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 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 laws. 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: Kimberly Compton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3168, Silver Spring, MD 20993-0002, 301-
796-1191, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Opioid analgesics vary in analgesic efficacy and potential for 
harm. MMEs or other similar conversion factors are used often to 
quantify potency across opioids, usually compared to oral morphine. MME 
tables were originally developed as an adjunct to clinical judgment to 
inform starting doses when switching patients between different opioid 
analgesics. However, MMEs are increasingly being used to indicate abuse 
and overdose potential and to set thresholds for prescribing and 
dispensing of opioid analgesics. FDA is convening this public workshop 
to discuss the current landscape and science underlying MMEs and their 
uses.

II. Topics for Discussion at the Public Workshop

    This public workshop will provide: (1) An overview of the landscape 
of MMEs, starting with a historical perspective of how MMEs were 
originally developed and intended to be used; (2) the data informing 
published resources on MMEs; (3) the development and intended use of 
commonly-referenced sources, such as the Centers for Disease Control 
and Prevention's resources; (4) the current uses of MMEs and gaps in 
knowledge; and (5) future directions to refine and improve the 
scientific basis of MME applications.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website to register: https://morphinemilligramequivalent.eventbrite.com. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone. Registration is free.
    If you need special accommodations due to a disability, please 
contact Kimberly Compton (see FOR FURTHER INFORMATION CONTACT) no later 
than May 17, 2021.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during the public comment session. 
Submit a brief statement of the topic you wish to address and the names 
and addresses of proposed participants. We will do our best to 
accommodate requests to make public comments. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their presentations and request time for a joint 
presentation. All requests to make oral presentations must be received 
by May 24, 2021. We will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin 
and will select and notify participants by May 31, 2021. Time allotted 
for each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled public comment session, FDA may conduct a lottery 
to determine the speakers for the scheduled public comment session. If 
selected for presentation, any presentation materials must be emailed 
to Kimberly Compton (see FOR FURTHER INFORMATION CONTACT) no later than 
June 3, 2021. No commercial or promotional material

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will be permitted to be presented or distributed at the public 
workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
be webcast. Additional information will be made available regarding 
accessing the webcast before the public workshop at https://morphinemilligramequivalent.eventbrite.com and at https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and-knowledge-gaps-research-opportunities-and. All other 
meeting materials, including agenda, will be available before the 
workshop at https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and-knowledge-gaps-research-opportunities-and.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and-knowledge-gaps-research-opportunities-and.

    Dated: April 12, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07837 Filed 4-15-21; 8:45 am]
BILLING CODE 4164-01-P