Patient-Focused Drug Development for Stimulant Use Disorder; Public Meeting; Request for Comments, 8877-8879 [2020-03159]
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Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices
responses should include a discussion
of how the information or data can be
applied specifically to tobacco products
or to lung injuries associated with the
use of vaping products.
For this RFI, FDA is requesting: (1)
Unpublished data or information
(summarized); (2) unpublished or
prepublication copies of manuscripts,
conference presentations, and/or
posters; (3) dissertations and/or theses;
and (4) white papers or other
unpublished reports. FDA is requesting
data and information from all interested
parties, including, but not limited to,
academic and government researchers,
industry, and any other sources.
Specifically, FDA is requesting
unpublished data or information on the
following:
• Specific chemicals, compounds,
ingredients or combinations of
ingredients that when inhaled or
aerosolized, may be associated with the
symptoms observed in ‘‘e-cigarette, or
vaping, product use-associated lung
injury’’ (EVALI) patients; e.g., cough,
chest pain, shortness of breath,
abdominal pain, nausea, vomiting,
diarrhea, fever, chills; 3
• nature of pulmonary pathological
changes associated with inhaling the
specific chemicals, compounds,
ingredients, or combinations of
ingredients that elicit the symptoms
observed in EVALI;
• methods or sources for obtaining
chemicals, compounds, ingredients, or
combinations of ingredients, other than
those intended by the manufacturer,
that are added to vaping products;
• in what ways and how frequently
consumers add chemicals, compounds,
ingredients or combinations of
ingredients, other than those intended
by the manufacturer, to vaping products
and how these changes affect the health
impacts, frequency, and patterns of
consumer use of the products;
• methods for identifying and
detecting materials added or
modifications to vaping products after
the manufacturing process and not
intended by the manufacturer; and
• methods of changing the
manufacturing process or product
design features for vaping products that
will reduce or prevent consumers from
modifying products after the
manufacturing process.
Data may come from studies outside
of the United States; however, FDA
prefers that reports be submitted in
English.
3 For more information concerning the symptoms
observed in EVALI patients, please see https://
www.cdc.gov/tobacco/basic_information/ecigarettes/severe-lung-disease/need-to-know/index.
html#symptoms.
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When submitting information, please
include details about how the data were
collected, including the sample
composition, year(s) of data collection,
and a detailed summary of the methods
and measures used. For data summaries,
please include both point estimates and
measures of variance, as well as effect
sizes (if available).
Please also note that when submitting
information and data to the docket,
certain compressed file formats (e.g., zip
files) are not allowed. Acceptable file
formats include: .doc, .docx, .pdf, .ppt,
.pptx, .rtf, .txt, .xls, .xlsx, .xlsm, .xlsb,
and .wpd.
Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03160 Filed 2–14–20; 8:45 am]
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
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
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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
BILLING CODE 4164–01–P
AGENCY:
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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.’’
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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-201509-18/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.
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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
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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-eventshuman-drugs/public-meeting-patientfocused-drug-development-stimulantuse-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 wellbeing, 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?
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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://stimulant
usedisorder-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
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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, firstserve 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://stimulant
usedisorder-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-feeamendments/fda-led-patient-focuseddrug-development-pfdd-publicmeetings.
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8879
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–E–5899 and FDA–
2017–E–5911]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; INTRAROSA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for INTRAROSA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 20, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 17, 2020. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: 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 April 20,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 20, 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.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [email protected].
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 [email protected] 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
