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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public meeting.

# 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,                         *Mitra.Ahadpour@fda.hhs.gov.*

# 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:
    - The role of FDA and the Department of Health and Human Services in confronting and combatting the opioid epidemic;
    - The current state of knowledge on addiction, clinical approaches for identifying and assessing OUD, and use of medication-assisted treatment;
    - Gaps in the pharmacological armamentarium for treating OUD, including shortfalls or unmet needs that should be considered in developing new therapies;
    - Innovative and evidence-based approaches to OUD treatment delivery, lessons learned, and challenges to broader implementation;
    - Legal, regulatory, and cultural barriers to access for treatment for OUD and potential opportunities to reduce stigma and expand access to effective OUD treatment;
    - Care models and challenges for increasing access to OUD treatment for vulnerable and medically underserved populations; and
    - 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,                     *sarah.supsiri@duke.edu*) 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                           ( print 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. Miniño, “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