[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11208-11210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0987]


Patient-Focused Drug Development on Opioid Use Disorder; Public 
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public meeting entitled ``Patient-Focused Drug 
Development on Opioid Use Disorder.'' The purpose of the public meeting 
is to obtain patients' perspectives on the impacts of and treatment 
approaches for opioid use disorder (OUD). This meeting is a part of 
FDA's ongoing work aimed at reducing the impact of opioid abuse and 
addiction.

DATES: The public meeting will be held on April 17, 2018, from 10 a.m. 
to 4 p.m. Submit either electronic or written comments on this public 
meeting by June 18, 2018. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 June 18, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of June 18, 2018. 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:
     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:

[[Page 11209]]

     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-2018-N-0987 for ``Patient-Focused Drug Development on Opioid Use 
Disorder; Public Meeting; 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.
     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 law. 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    This meeting will provide FDA the opportunity to better understand 
the patient perspective on the impacts of OUD and on treatment 
approaches for OUD. OUD is the diagnostic term used for a chronic 
neurobiological disease characterized by a problematic pattern of 
opioid use leading to significant impairment or distress. OUD includes 
signs and symptoms that reflect compulsive, prolonged self-
administration of opioid substances for no legitimate medical purpose, 
or, if another medical condition is present that required opioid 
treatment, the opioid is used in doses far greater than the amount 
needed for treatment of that medical condition. FDA is interested in 
learning patients' perspectives on OUD, including the effects on their 
health and well-being that have the greatest negative effect on daily 
life, their experience using prescription medical treatments and other 
treatments or therapies for OUD, and challenges or barriers to 
accessing or using medical treatments for OUD.
    There are three drugs approved by FDA for the treatment of OUD: 
Buprenorphine, methadone, and naltrexone. FDA is taking steps to 
facilitate the development of new medications for the treatment of OUD 
and new formulations of existing drugs that could better suit patient 
needs. Promoting wider appropriate use of these safe and effective 
medications is also the focus of FDA's ongoing work to reduce the scope 
and magnitude of the opioid crisis.
    At the meeting, patients and patient representatives will provide 
patient perspectives on the symptoms and daily impacts of OUD and on 
treatment approaches for OUD. The questions that will be asked of 
patients and patient representatives at the meeting are listed in the 
following section and organized by topic. For each topic, a brief 
initial patient panel discussion will begin the dialogue. This will be 
followed by a facilitated discussion inviting comments from other 
patient and patient representative participants. In addition to input 
generated through this public meeting, FDA is interested in receiving 
patient and patient representative input addressing these questions 
through written comments, which can be submitted to the public docket 
(see ADDRESSES). When submitting comments, if you are commenting on 
behalf of a patient, please indicate that you are doing so and answer 
the following questions as much as possible from the patient's 
perspective.
    FDA will post the agenda and other meeting materials approximately 
5 days before the meeting at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm591290.htm.

II. Topics for Discussion at the Public Meeting

Topic 1: Symptoms and Daily Impacts of OUD That Matter Most to Patients

    1. Of all the ways that OUD negatively affects your health and 
well-being, which effects have the most significant impact on your 
daily life? Examples of negative effects may include:
     Effects of using opioids, such as confusion, constipation, 
or other symptoms;
     Effects of opioid withdrawal, such as nausea, diarrhea, or 
other symptoms;
     Effects of opioid ``cravings;''
     Impacts on ability to function in personal or professional 
life;
     Emotional or social effects; and
     Other potential effects.
    2. How does OUD affect daily life on your best days? On your worst 
days?
    3. How has your OUD changed over time?
    4. What worries you most about your condition?

Topic 2: Patients' Perspectives on Current Approaches to Treatment of 
OUD

    1. Are you currently using, or have you used in the past, any 
prescription medical treatments to treat your OUD? Such treatments may 
include buprenorphine, methadone, naltrexone, and others that your 
health care provider has prescribed. If so, please describe your 
experiences with these treatments.
     How well have these treatments worked for you? How well 
have they helped address the effects of OUD that are most bothersome to 
you?
     What are the biggest problems you have faced in using 
these treatments? Examples may include bothersome side effects, 
challenges getting the medicines, concern about stigma, and other 
possible problems.

[[Page 11210]]

    2. Besides prescription medical treatments, are there other 
treatments or therapies that you currently use to address your OUD? If 
so, please describe. How well do these treatments or therapies help 
address the effects of OUD that are most bothersome to you?
    3. Of all treatments, therapies, or other steps that you have taken 
to address your OUD, what have you found to be most effective in 
helping you manage your OUD?
    4. What are the biggest factors that you take into account when 
making decisions about seeking out or using treatments for OUD?
    5. What specific things would you look for in an ideal treatment 
for OUD?
    6. If you had the opportunity to consider participating in a 
clinical trial studying experimental treatments for OUD, what factors 
would you consider when deciding whether or not to participate?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, visit https://www.eventbrite.com/e/public-meeting-for-patient-focused-drug-development-on-opioid-use-disorder-oud-registration-42531194949. Please 
register by April 11, 2018. Please provide complete contact information 
for each attendee, including name, title, affiliation, address, email, 
and telephone. Persons without access to the internet can call 240-402-
6525 to register. If you are unable to attend the meeting in person, 
you can register to view a live webcast of the meeting. You will be 
asked to indicate in your registration if you plan to attend in person 
or via the webcast.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by April 11, 2018. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation when they have been accepted. If time and space permit, 
onsite registration on the day of the public meeting will be provided 
beginning at 9 a.m.
    If you need special accommodations because of a disability, please 
contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) no 
later than April 11, 2018.
    Panelist Selection: Patients or patient representatives who are 
interested in presenting comments as part of the initial panel 
discussions will be asked to indicate in their registration which 
topic(s) they wish to address. These patients or patient 
representatives also will be asked to send [email protected] a 
brief summary of responses to the topic questions by April 2, 2018. 
Panelists will be notified of their selection approximately 7 days 
before the public meeting. We will try to accommodate all patients and 
patient stakeholders who wish to speak, either through the panel 
discussion or audience participation; however, the duration of comments 
may be limited by time constraints.
    Open Public Comment: There will be time allotted during the meeting 
for open public comment. Sign-up for this session will be on a first-
come, first-serve basis on the day of the workshop. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate and request time for a joint presentation. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public workshop.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please register for the webcast by visiting https://www.eventbrite.com/e/public-meeting-for-patient-focused-drug-development-on-opioid-use-disorder-oud-registration-42531194949.
    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 meeting 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/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm591290.htm.

    Dated: March 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05119 Filed 3-13-18; 8:45 am]
 BILLING CODE 4164-01-P


