[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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