[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42508-42509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18071]



[[Page 42508]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2904]


Expanding Access to Effective Treatment for Opioid Use Disorder: 
Provider Perspectives on Reducing Barriers to Evidence-Based Care; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
following public meeting entitled ``Expanding Access to Effective 
Treatment for Opioid Use Disorder: Provider Perspectives on Reducing 
Barriers to Evidence-Based Care.'' Convened by the Duke-Robert J. 
Margolis, MD, Center for Health Policy at Duke University and supported 
by a cooperative agreement with FDA, the public meeting is intended to 
generate a discussion with providers and health system stakeholders on 
the armamentarium of medications to treat opioid use disorder (OUD), 
current barriers to appropriate use of these medications, opportunities 
to further reduce stigma, and methods to expand access to effective 
pharmacotherapies as part of an evidence-based approach to OUD 
treatment.

DATES: The public meeting will be held on September 20, 2018, from 9 
a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at the National Press Club, 
529 14th St. NW, Washington, DC 20045. For additional travel and hotel 
information, please refer to the following web page: https://healthpolicy.duke.edu/events/expanding-access-to-treatment-for-OUD. 
There will also be a live webcast for those unable to attend the 
meeting in person (see Streaming Webcast of the Public Meeting).

FOR FURTHER INFORMATION CONTACT: Mitra Ahadpour, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4546, Silver Spring, MD 20993-0002, 301-
796-8469, <a href="/cdn-cgi/l/email-protection#99d4f0edebf8b7d8f1f8fde9f6ecebd9fffdf8b7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="aee3c7dadccf80efc6cfcadec1dbdceec8cacf80c6c6dd80c9c1d8">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    The opioid epidemic remains a growing public health crisis. FDA 
efforts to address the opioid crisis have included, among other things, 
revision of the document entitled ``FDA Education Blueprint for Health 
Care Providers Involved in the Management or Support of Patients with 
Pain'' (https://www.fda.gov/Drugs/NewsEvents/ucm553931.htm), to support 
rational prescribing, packaging, storage, and disposal of opioids; 
stemming illegal opioid sales; expanding the Risk Evaluation and 
Mitigation Strategy to cover immediate-release opioid formulations; 
monitoring the abuse potential of marketed opioids and taking 
regulatory action as needed; and addressing barriers to new drug 
development for non-opioid alternative treatment of pain. Despite these 
efforts and those of others, opioid misuse, OUD, and overdose remain 
major public health challenges (Refs. 1 and 2).
    Over 2.1 million persons aged 12 or older suffer from opioid use 
disorders related to prescription opioid analgesics or heroin (Ref. 2), 
and the majority of those suffering from OUD still lack access to 
evidence-based treatment. Although there is no one-size-fits-all 
approach to OUD treatment, there is strong evidence demonstrating the 
effectiveness of FDA-approved medications, combined with counseling and 
behavioral therapies, for these patients. Promoting the wider use of 
these safe and effective therapies is a key priority of FDA. However, 
substantial challenges remain in patient access and provider use of 
medications for OUD treatment.
    This public meeting is intended to serve as a platform to engage in 
and generate an active discussion with provider communities and health 
system stakeholders on the armamentarium of medications to treat OUD, 
barriers to appropriate use of these medications, opportunities to 
further reduce stigma, and methods to expand access to effective OUD 
treatment.

II. Topics for Discussion at the Public Meeting

    During the public meeting, speakers and participants will cover 
issues related to expanding access to effective treatment for OUD, 
specifically in regard to provider perspectives on reducing barriers to 
evidence-based care. Topics will include, but are not limited to, the 
following:
    <bullet> The role of FDA and the Department of Health and Human 
Services in confronting and combatting the opioid epidemic;
    <bullet> The current state of knowledge on addiction, clinical 
approaches for identifying and assessing OUD, and use of medication-
assisted treatment;
    <bullet> Gaps in the pharmacological armamentarium for treating 
OUD, including shortfalls or unmet needs that should be considered in 
developing new therapies;
    <bullet> Innovative and evidence-based approaches to OUD treatment 
delivery, lessons learned, and challenges to broader implementation;
    <bullet> Legal, regulatory, and cultural barriers to access for 
treatment for OUD and potential opportunities to reduce stigma and 
expand access to effective OUD treatment;
    <bullet> Care models and challenges for increasing access to OUD 
treatment for vulnerable and medically underserved populations; and
    <bullet> Clinical, health system, and economic perspectives on 
defining successful outcomes for OUD treatment, including how 
establishing outcome measures may facilitate quality improvement, 
innovative payment approaches, and access to effective care.
    During meeting sessions, audience and webcast participants will be 
invited to actively participate in the discussion regarding provider 
and clinical expert perspectives on treatment for OUD and barriers to 
care.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online at https://healthpolicy.duke.edu/expanding-access-to-treatment-for-OUD by September 19, 2018, by 5 p.m. Eastern Time. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email address, and 
telephone number.
    Registration is free and based on space availability, with priority 
given to early registrants. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization. Registrants will receive confirmation when the 
registration has been accepted. If time and space permit, onsite 
registration on the day of the public meeting will be provided 
beginning at 8 a.m. We will let registrants know if registration closes 
before the day of the public meeting.
    If you need special accommodations due to a disability, please 
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy 
(202-791-9561, <a href="/cdn-cgi/l/email-protection#74071506151c5a070104071d061d3410011f115a111001"><span class="__cf_email__" data-cfemail="d8abb9aab9b0f6abada8abb1aab198bcadb3bdf6bdbcad">[email protected]</span></a>) no later than September 13, 
2018.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast, and archived video footage will be available at the 
Duke-Margolis

[[Page 42509]]

Center's website following the meeting: https://healthpolicy.duke.edu/events/expanding-access-to-treatment-for-OUD. Webcast participants will 
be able to submit questions and comments via the webcast portal. 
Persons interested in participating in the live webcast must register 
online by September 19, 2018, by 5 p.m. Eastern Time (see Registration 
section above). Early registration is recommended because webcast 
connections are limited. Organizations are required to register all 
participants; however, we request that organizations view the meeting 
using one connection per location whenever possible.
    Other Issues for Consideration: All event materials will be 
provided to registered attendees via email prior to the meeting and 
will be made publicly available at the Duke-Margolis Center's website: 
https://healthpolicy.duke.edu/events/expanding-access-to-treatment-for-OUD. A 1-hour lunch break is scheduled, but food will not be provided. 
There are multiple restaurants within walking distance of the 
Conference Center.

IV. References

    The following references are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Hedegaard, H., M. Warner, and A.M. Mini[ntilde]o, ``Drug Overdose 
Deaths in the United States, 1999-2016,'' NCHS Data Brief, no. 294, 
Hyattsville, MD: National Center for Health Statistics. 2017 
(available at https://www.cdc.gov/nchs/products/databriefs/db294.htm), accessed June 27, 2018.
2. Substance Abuse and Mental Health Services Administration, Center 
for Behavioral Health Statistics and Quality, ``Results from the 
2016 National Survey on Drug Use and Health: Detailed Tables.'' 
September 8, 2016 (available at https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm), accessed 
June 27, 2018.


    Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18071 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P


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