[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