[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
[Notices]
[Pages 8877-8879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0259]


Patient-Focused Drug Development for Stimulant 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 for Stimulant Use Disorder.'' The purpose of the public 
meeting is to allow FDA to obtain stakeholder perspectives on the 
impact of stimulant use disorder and views on treatment approaches for 
stimulant use disorder.

DATES: The public meeting will be held on March 10, 2020, from 12:30 
p.m. to 5 p.m. Submit either electronic or written comments on this 
public meeting by May 11, 2020. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at the Silver Spring Civic 
Building, 1 Veterans Pl., Silver Spring, MD 20910. The building is 
located at Veterans Plaza in downtown Silver Spring and is accessible 
via the Silver Spring Metro Station on the Red Line. Paid public 
parking is also available at the Town Square Garage (Garage 61), 801 
Ellsworth Dr., Silver Spring, MD 20910, and the Wayne-Ellsworth Garage 
(Garage 60), 921 Wayne Ave., Silver Spring, MD 20910. For more 
information regarding parking, Metro access, and the meeting location, 
please refer to https://www.montgomerycountymd.gov/cupf/info-reservation/SSCB.html.
    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 May 11, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of May 11, 2020. 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:
     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.''

[[Page 8878]]

    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-0259 for ``Patient-Focused Drug Development for Stimulant 
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.govinfo.gov/content/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: Lyna Merzoug, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6308, Silver Spring, MD 20993-0002, 301-
796-6001, PatientFocused@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    This meeting will provide FDA the opportunity to obtain input from 
individuals with stimulant use disorder and other related stakeholders 
on the impact of stimulant use disorder and views on treatment goals 
and approaches. FDA is interested in stakeholders' perspectives on: (1) 
The health effects and daily impacts of their condition; (2) the impact 
(if any) of opioid and polysubstance use on their condition; (3) 
treatment goals; and (4) decision factors considered when seeking out 
or selecting a treatment.
    Stimulant use disorder describes a range of problems associated 
with the use of illicit stimulant drugs, including methamphetamine and 
cocaine, and prescription stimulants (e.g., ADDERALL, RITALIN), but not 
including caffeine or nicotine. A diagnosis of stimulant use disorder 
is made when a clinician identifies a pattern of use of amphetamine-
type substance, cocaine, or other stimulant that leads to clinically 
significant impairment or distress, including an inability to reduce or 
control consumption, cravings to use a stimulant, continued use of a 
stimulant despite it causing negative consequences, and the need to use 
increased amounts of a stimulant to achieve the desired effect. There 
are no FDA-approved medications for stimulant use disorder.
    The questions that will be asked of individuals with stimulant use 
disorder and other stakeholders at the meeting are listed in the 
following section and organized by topic. For each topic, a brief 
initial panel discussion will begin the dialogue. This will be followed 
by a facilitated discussion inviting comments from other audience 
participants. In addition to input generated through this public 
meeting, FDA is interested in receiving stakeholder input addressing 
these questions through written comments, which can be submitted to the 
public docket (see ADDRESSES). As noted above, when submitting 
comments, 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.'' When submitting comments, if you are 
commenting on behalf of a stimulant user, please indicate that you are 
doing so and answer the following questions as much as possible from 
the stimulant user's perspective, but please refrain from providing 
information that would identify third parties, including minor 
children.
    FDA will post the agenda and other meeting materials approximately 
5 days before the meeting at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-stimulant-use-disorder-03102020-03102020.

II. Discussion Questions at the Public Meeting

A. Topic 1: Health Effects and Daily Impacts

    1. How would you describe your experience with stimulant use 
disorder?
    a. Which stimulant(s) did you start using first?
    b. What stimulant(s) are you using now?
    c. Did you use any other illicit or prescription drugs before you 
started using the stimulant that you are currently using?
    d. How are you using stimulants? How has your stimulant(s) use 
changed over time? Are you using more frequently or at higher doses?
    e. Do you use stimulants in combination with other drug(s)? If so, 
what other drugs do you use and why?
    f. Have you used a stimulant(s) as treatment for opioid withdrawal 
and/or overdose?
    2. Of all the ways that stimulant use disorder impacts your health 
and well-being, which effects have the most significant impact on your 
daily life and the daily life of your family and/or friends? Examples 
may include physical and mental effects of using stimulants (effects on 
your body and thinking), effects of stimulant withdrawal, effects of 
cravings, impacts on your ability to function in personal or 
professional life, or emotional or social effects.
    a. What drives your use of stimulants?
    b. Are there certain activities that you can only do if you take a 
stimulant? If so, what are those activities?
    c. Are there specific activities that are important to you but that 
you cannot do at all or as fully as you would like because of your 
stimulant use? Examples of activities may include daily hygiene; 
meeting school, work, or family responsibilities; participation in 
social activities.
    d. How does your stimulant use affect daily life on your best days? 
On your worst days?
    3. What worries you most about your condition?

B. Topic 2: Current Approaches to Management

    1. Have you considered seeking treatment? Why or why not?

[[Page 8879]]

    2. What are you currently doing to help manage your stimulant use?
    a. How well have these management approaches worked for you?
    b. How well have they helped address the effects of stimulant use 
that are most troubling to you?
    c. What are the biggest problems you have faced in using these 
approaches? Examples may include bothersome side effects, challenges or 
barriers to access, concern about stigma.
    3. What are the biggest factors that you consider when making 
decisions about seeking out or engaging in treatment for stimulant use 
disorder?
    4. What specific things would you look for in an ideal treatment 
for stimulant use disorder?
    5. If you had the opportunity to participate in a clinical study to 
test an experimental treatment for stimulant use disorder, what factors 
would you consider when deciding whether you would participate?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, visit https://stimulantusedisorder-pfdd.eventbrite.com/. Contact information provided 
during registration will remain confidential and only be used to send 
meeting updates to participants.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by March 3, 2020, 11:59 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. If time 
and space permit, onsite registration on the day of the public meeting 
will be provided beginning at 11:30 a.m.
    If you need special accommodations due to a disability, please 
contact Lyna Merzoug (SEE FURTHER INFORMATION CONTACT) no later than 
March 3, 2020.
    Panelist Selection: Stakeholders, particularly people suffering 
from stimulant use disorder, 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 
stakeholders also will be asked to send PatientFocused@fda.hhs.gov a 
brief summary of responses to the discussion questions listed above by 
February 26, 2020. Panelists will be notified of their selection 
approximately 7 days before the public meeting. We will try to 
accommodate all 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. Signup 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.
    Persons attending FDA's meetings are advised that FDA is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the public meeting: FDA will also stream a 
live audio recording of this public meeting with the presentation 
slides. The audio recording and presentation slides, along with a 
meeting transcript and summary report, will also be made publicly 
available after the meeting. Because of the sensitive nature of the 
meeting topic, and the importance of gathering candid, meaningful input 
from individuals who have come forward to speak about living with 
stimulant use disorder, no other audio recording, video recording, and/
or photography will be allowed at this Patient-Focused Drug Development 
meeting. FDA is asking for your cooperation and strongly requests that 
you respect the privacy of all attendees. You will be asked to indicate 
in your registration whether you plan to attend in person or via the 
webcast. To register for the webcast, please visit https://stimulantusedisorder-pfdd.eventbrite.com/.
    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/industry/prescription-drug-user-fee-amendments/fda-led-patient-focused-drug-development-pfdd-public-meetings.

    Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03159 Filed 2-14-20; 8:45 a.m.]
BILLING CODE 4164-01-P


