[Federal Register Volume 85, Number 190 (Wednesday, September 30, 2020)]
[Notices]
[Pages 61756-61758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21623]


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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: In the Federal Register notice published on March 19, 2020, 
the Food and Drug Administration (FDA, the Agency, or we) announced the 
cancellation of the meeting entitled ``Patient-Focused Drug Development 
for Stimulant Use Disorder'' originally scheduled to occur on March 10, 
2020, as announced in the Federal Register on February 18, 2020. FDA is 
announcing a new date for the meeting, to occur in a virtual format. 
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 October 6, 2020, from 12:30 
p.m. Eastern Time to 5 p.m. Eastern Time. Submit either electronic or 
written comments on this public meeting by December 7, 2020. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this public meeting via an 
online conferencing platform.
    The docket number to accept comments is FDA-2020-N-0259. Please 
note that late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before December 7, 2020. 
The https://www.regulations.gov electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of December 7, 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.''
    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, 240-402-7500.
     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, 240-402-7500.

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, [email protected].

[[Page 61757]]


SUPPLEMENTARY INFORMATION:

I. Background

    On March 19, 2020, FDA announced in the Federal Register (85 FR 
15789) the cancellation of the meeting entitled ``Patient-Focused Drug 
Development for Stimulant Use Disorder'' originally scheduled to occur 
on March 10, 2020, as announced in the Federal Register on February 18, 
2020 (85 FR 8877). The meeting has been rescheduled in a virtual 
format.
    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?
    2. If you are using more than one substance, would stimulant use be 
the primary or secondary reason to consider treatment?
a. If not stimulants, what substance would be the primary reason you 
would seek treatment?
3. 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.
    4. What are the biggest factors that you consider when making 
decisions about seeking out or engaging in treatment for stimulant use 
disorder?
    5. What specific things would you look for in an ideal treatment 
for stimulant use disorder?
    6. 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?

C. Topic 3: Impact of COVID-19

    1. Has the COVID-19 pandemic impacted your substance use or your 
desire to seek treatment? If yes, please describe how.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
via webcast must register online at https://pfdd-stimulantusedisorder.eventbrite.com. Contact information provided 
during registration will remain confidential and will only be used to 
send meeting updates to participants.
    Registration for this virtual event is free, although there may be 
limited space for attendance based on bandwidth availability. Webcast 
information will be provided upon completion of registration. Closed

[[Page 61758]]

captioning will be provided. Please check the meeting website for the 
latest information: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-stimulant-use-disorder-03102020-03102020.
    Streaming Webcast of the Public Meeting: This public meeting will 
be streamed via webcast only. The recording and presentation slides, 
along with a meeting transcript and summary report, will also be made 
publicly available after the meeting. To register for the webcast, 
please visit https://pfdd-stimulantusedisorder.eventbrite.com. The 
webcast can be accessed via http://fda.yorkcast.com/webcast/Play/89f7acb8d56e4de8827d1ade8efa42661d. Simply click on the link and hit 
the ``play'' button and it will start. The webcast link will be 
activated 30 minutes prior to the start of the meeting.
    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 
meeting website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-stimulant-use-disorder-03102020-03102020.

    Dated: September 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21623 Filed 9-29-20; 8:45 am]
BILLING CODE 4164-01-P