83 FR 42508 - Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 163 (August 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 163 (August 22, 2018)
| Page Range | 42508-42509 | |
| FR Document | 2018-18071 |
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)] [Notices] [Pages 42508-42509] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18071] [[Page 42508]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [[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
![42508 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
DEPARTMENT OF HEALTH AND to address the opioid crisis have identifying and assessing OUD, and use
HUMAN SERVICES included, among other things, revision of medication-assisted treatment;
of the document entitled ‘‘FDA • Gaps in the pharmacological
Food and Drug Administration Education Blueprint for Health Care armamentarium for treating OUD,
[Docket No. FDA–2018–N–2904] Providers Involved in the Management including shortfalls or unmet needs that
or Support of Patients with Pain’’ should be considered in developing new
Expanding Access to Effective (https://www.fda.gov/Drugs/ therapies;
Treatment for Opioid Use Disorder: NewsEvents/ucm553931.htm), to • Innovative and evidence-based
Provider Perspectives on Reducing support rational prescribing, packaging, approaches to OUD treatment delivery,
Barriers to Evidence-Based Care; storage, and disposal of opioids; lessons learned, and challenges to
Public Meeting stemming illegal opioid sales; broader implementation;
expanding the Risk Evaluation and • Legal, regulatory, and cultural
AGENCY: Food and Drug Administration, Mitigation Strategy to cover immediate- barriers to access for treatment for OUD
HHS. release opioid formulations; monitoring and potential opportunities to reduce
ACTION: Notice of public meeting. the abuse potential of marketed opioids stigma and expand access to effective
and taking regulatory action as needed; OUD treatment;
SUMMARY: The Food and Drug
and addressing barriers to new drug • Care models and challenges for
Administration (FDA or we) is increasing access to OUD treatment for
development for non-opioid alternative
announcing the following public vulnerable and medically underserved
treatment of pain. Despite these efforts
meeting entitled ‘‘Expanding Access to populations; and
and those of others, opioid misuse,
Effective Treatment for Opioid Use
OUD, and overdose remain major public • Clinical, health system, and
Disorder: Provider Perspectives on economic perspectives on defining
health challenges (Refs. 1 and 2).
Reducing Barriers to Evidence-Based successful outcomes for OUD treatment,
Over 2.1 million persons aged 12 or
Care.’’ Convened by the Duke-Robert J. including how establishing outcome
older suffer from opioid use disorders
Margolis, MD, Center for Health Policy measures may facilitate quality
related to prescription opioid analgesics
at Duke University and supported by a improvement, innovative payment
or heroin (Ref. 2), and the majority of
cooperative agreement with FDA, the approaches, and access to effective care.
those suffering from OUD still lack
public meeting is intended to generate During meeting sessions, audience
access to evidence-based treatment.
a discussion with providers and health and webcast participants will be invited
Although there is no one-size-fits-all
system stakeholders on the to actively participate in the discussion
approach to OUD treatment, there is
armamentarium of medications to treat regarding provider and clinical expert
strong evidence demonstrating the
opioid use disorder (OUD), current perspectives on treatment for OUD and
effectiveness of FDA-approved
barriers to appropriate use of these barriers to care.
medications, combined with counseling
medications, opportunities to further
and behavioral therapies, for these III. Participating in the Public Meeting
reduce stigma, and methods to expand
patients. Promoting the wider use of Registration: Persons interested in
access to effective pharmacotherapies as
these safe and effective therapies is a attending this public meeting must
part of an evidence-based approach to
key priority of FDA. However, register online at https://
OUD treatment.
substantial challenges remain in patient healthpolicy.duke.edu/expanding-
DATES: The public meeting will be held
access and provider use of medications access-to-treatment-for-OUD by
on September 20, 2018, from 9 a.m. to for OUD treatment.
4 p.m. See the SUPPLEMENTARY September 19, 2018, by 5 p.m. Eastern
This public meeting is intended to Time. Please provide complete contact
INFORMATION section for registration date
serve as a platform to engage in and information for each attendee, including
and information. generate an active discussion with
ADDRESSES: The public meeting will be
name, title, affiliation, address, email
provider communities and health address, and telephone number.
held at the National Press Club, 529 system stakeholders on the Registration is free and based on
14th St. NW, Washington, DC 20045. armamentarium of medications to treat space availability, with priority given to
For additional travel and hotel OUD, barriers to appropriate use of early registrants. Early registration is
information, please refer to the these medications, opportunities to recommended because seating is
following web page: https:// further reduce stigma, and methods to limited; therefore, FDA may limit the
healthpolicy.duke.edu/events/ expand access to effective OUD number of participants from each
expanding-access-to-treatment-for-OUD. treatment. organization. Registrants will receive
There will also be a live webcast for
II. Topics for Discussion at the Public confirmation when the registration has
those unable to attend the meeting in
Meeting been accepted. If time and space permit,
person (see Streaming Webcast of the
onsite registration on the day of the
Public Meeting). During the public meeting, speakers public meeting will be provided
FOR FURTHER INFORMATION CONTACT: and participants will cover issues beginning at 8 a.m. We will let
Mitra Ahadpour, Center for Drug related to expanding access to effective registrants know if registration closes
Evaluation and Research, Food and treatment for OUD, specifically in before the day of the public meeting.
Drug Administration, 10903 New regard to provider perspectives on If you need special accommodations
Hampshire Ave., Bldg. 21, Rm. 4546, reducing barriers to evidence-based due to a disability, please contact Sarah
Silver Spring, MD 20993–0002, 301– care. Topics will include, but are not Supsiri at the Duke-Margolis Center for
amozie on DSK3GDR082PROD with NOTICES1
796–8469, Mitra.Ahadpour@ limited to, the following: Health Policy (202–791–9561,
fda.hhs.gov. • The role of FDA and the sarah.supsiri@duke.edu) no later than
SUPPLEMENTARY INFORMATION: Department of Health and Human September 13, 2018.
Services in confronting and combatting Streaming Webcast of the Public
I. Background the opioid epidemic; Meeting: This public meeting will also
The opioid epidemic remains a • The current state of knowledge on be webcast, and archived video footage
growing public health crisis. FDA efforts addiction, clinical approaches for will be available at the Duke-Margolis
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![Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42509
Center’s website following the meeting: DEPARTMENT OF HEALTH AND the docket unchanged. Because your
https://healthpolicy.duke.edu/events/ HUMAN SERVICES comment will be made public, you are
expanding-access-to-treatment-for-OUD. solely responsible for ensuring that your
Webcast participants will be able to Food and Drug Administration comment does not include any
submit questions and comments via the [Docket No. FDA–2011–N–0449]
confidential information that you or a
webcast portal. Persons interested in third party may not wish to be posted,
participating in the live webcast must Agency Information Collection such as medical information, your or
register online by September 19, 2018, Activities; Proposed Collection; anyone else’s Social Security number, or
by 5 p.m. Eastern Time (see Registration Comment Request; Sun Protection confidential business information, such
section above). Early registration is Factor Labeling and Testing as a manufacturing process. Please note
recommended because webcast Requirements for Over-the-Counter that if you include your name, contact
connections are limited. Organizations Sunscreen Drug Products information, or other information that
are required to register all participants; identifies you in the body of your
however, we request that organizations AGENCY: Food and Drug Administration, comments, that information will be
view the meeting using one connection HHS. posted on https://www.regulations.gov.
per location whenever possible. ACTION: Notice. • If you want to submit a comment
with confidential information that you
Other Issues for Consideration: All SUMMARY: The Food and Drug do not wish to be made available to the
event materials will be provided to Administration (FDA or Agency) is public, submit the comment as a
registered attendees via email prior to announcing an opportunity for public written/paper submission and in the
the meeting and will be made publicly comment on the proposed collection of manner detailed (see ‘‘Written/Paper
available at the Duke-Margolis Center’s certain information by the Agency. Submissions’’ and ‘‘Instructions’’).
website: https://healthpolicy.duke.edu/ Under the Paperwork Reduction Act of
events/expanding-access-to-treatment- Written/Paper Submissions
1995 (PRA), Federal Agencies are
for-OUD. A 1-hour lunch break is required to publish notice in the Submit written/paper submissions as
scheduled, but food will not be Federal Register concerning each follows:
provided. There are multiple restaurants proposed collection of information, • Mail/Hand delivery/Courier (for
within walking distance of the including each proposed extension of an written/paper submissions): Dockets
Conference Center. existing collection of information, and Management Staff (HFA–305), Food and
IV. References to allow 60 days for public comment in Drug Administration, 5630 Fishers
response to the notice. This notice Lane, Rm. 1061, Rockville, MD 20852.
The following references are on solicits comments on sun protection • For written/paper comments
display in the Dockets Management factor (SPF) labeling and testing submitted to the Dockets Management
Staff (HFA–305), Food and Drug requirements for over-the-counter (OTC) Staff, FDA will post your comment, as
Administration, 5630 Fishers Lane, Rm. sunscreen products containing specified well as any attachments, except for
1061, Rockville, MD 20852, and are ingredients and marketed without information submitted, marked and
available for viewing by interested approved applications, and comments identified, as confidential, if submitted
persons between 9 a.m. and 4 p.m., on compliance with Drug Facts labeling as detailed in ‘‘Instructions.’’
Monday through Friday; they are also requirements for all OTC sunscreen Instructions: All submissions received
available electronically at https:// products. must include the Docket No. FDA–
www.regulations.gov. FDA has verified 2011–N–0449 for ‘‘Agency Information
DATES: Submit either electronic or Collection Activities; Proposed
the website addresses, as of the date this
written comments on the collection of Collection; Comment Request; Sun
document publishes in the Federal
information by October 22, 2018. Protection Factor Labeling and Testing
Register, but websites are subject to
change over time. ADDRESSES: You may submit comments Requirements and Drug Facts Labeling
as follows. Please note that late, for Over-the-Counter Sunscreen Drug
1. Hedegaard, H., M. Warner, and A.M. untimely filed comments will not be Products.’’ Received comments, those
Miniño, ‘‘Drug Overdose Deaths in the filed in a timely manner (see
considered. Electronic comments must
United States, 1999–2016,’’ NCHS Data
be submitted on or before October 22, ADDRESSES), will be placed in the docket
Brief, no. 294, Hyattsville, MD: National
Center for Health Statistics. 2017
2018. The https://www.regulations.gov and, except for those submitted as
(available at https://www.cdc.gov/nchs/ electronic filing system will accept ‘‘Confidential Submissions,’’ publicly
products/databriefs/db294.htm), comments until midnight Eastern Time viewable at https://www.regulations.gov
accessed June 27, 2018. at the end of October 22, 2018. or at the Dockets Management Staff
2. Substance Abuse and Mental Health Comments received by mail/hand between 9 a.m. and 4 p.m., Monday
Services Administration, Center for delivery/courier (for written/paper through Friday.
Behavioral Health Statistics and Quality, submissions) will be considered timely • Confidential Submissions—To
‘‘Results from the 2016 National Survey if they are postmarked or the delivery submit a comment with confidential
on Drug Use and Health: Detailed service acceptance receipt is on or information that you do not wish to be
Tables.’’ September 8, 2016 (available at before that date. made publicly available, submit your
https://www.samhsa.gov/data/sites/ comments only as a written/paper
default/files/NSDUH-DetTabs-2016/ Electronic Submissions submission. You should submit two
NSDUH-DetTabs-2016.htm), accessed Submit electronic comments in the copies total. One copy will include the
amozie on DSK3GDR082PROD with NOTICES1
June 27, 2018. following way: information you claim to be confidential
• Federal eRulemaking Portal: with a heading or cover note that states
Dated: August 16, 2018.
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. Comments submitted electronically, Agency will review this copy, including
[FR Doc. 2018–18071 Filed 8–21–18; 8:45 am] including attachments, to https:// the claimed confidential information, in
BILLING CODE 4164–01–P www.regulations.gov will be posted to its consideration of comments. The
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Document Created: 2018-08-22 00:38:41
Document Modified: 2018-08-22 00:38:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting. | |
| 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. | |
| 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, [email protected] | |
| FR Citation | 83 FR 42508 |
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