Patient-Focused Drug Development on Opioid Use Disorder; Public Meeting; Request for Comments, 11208-11210 [2018-05119]
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Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
approval of four abbreviated new drug
applications (ANDAs) from two
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0793]
Sun Pharmaceutical Industries, Ltd.,
and Sun Pharma Global FZE;
Withdrawal of Approval of Four
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Approval is withdrawn as of
April 13, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
Notice.
The Food and Drug
Administration (FDA) is withdrawing
SUMMARY:
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 075556 ........
Enalapril Maleate Tablets USP, 2.5 milligrams (mg), 5 mg,
10 mg, and 20 mg.
ANDA 076045 ........
ANDA 078055 ........
ANDA 090018 ........
Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg ..............
Zolpidem Tartrate Tablets USP, 5 mg and 10 mg ................
Zoledronic Acid for Injection, Equivalent to 4 mg base/vial ..
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
Do.
Do.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 13,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on April 13, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: March 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05120 Filed 3–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
daltland on DSKBBV9HB2PROD with NOTICES
[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.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
SUMMARY:
VerDate Sep<11>2014
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Jkt 244001
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/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/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
PO 00000
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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:
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Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
• 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/201523389.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
VerDate Sep<11>2014
18:17 Mar 13, 2018
Jkt 244001
‘‘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,
Meghana.Chalasani@fda.hhs.gov.
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 selfadministration 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
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11209
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.
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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-meetingfor-patient-focused-drug-developmenton-opioid-use-disorder-oud-registration42531194949. 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
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18:17 Mar 13, 2018
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will be asked to send PatientFocused@
fda.hhs.gov 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, 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.
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-meetingfor-patient-focused-drug-developmenton-opioid-use-disorder-oud-registration42531194949.
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/For
Industry/UserFees/PrescriptionDrug
UserFee/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
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0740]
M7(R1): Assessment and Control of
Deoxyribonucleic Acid Reactive
(Mutagenic) Impurities in
Pharmaceuticals To Limit Potential
Carcinogenic Risk; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance entitled ‘‘M7(R1): Assessment
and Control of Deoxyribonucleic Acid
(DNA) Reactive (Mutagenic) Impurities
in Pharmaceuticals to Limit Potential
Carcinogenic Risk.’’ This guidance
updates and replaces the May 2015
guidance for industry ‘‘M7 Assessment
and Control of DNA Reactive
(Mutagenic) Impurities in
Pharmaceuticals to Limit Potential
Carcinogenic Risk.’’ This guidance
finalizes the draft guidance ‘‘M7(R1)
Addendum to ICH M7: Assessment and
Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals to Limit
Potential Carcinogenic Risk,’’ issued
September 28, 2015 (80 FR 58261).
The guidance was prepared under the
auspices of the International Council for
Harmonisation (ICH), formerly the
International Conference on
Harmonisation. This M7(R1) document
provides guidance on acceptable intakes
(AIs), or permissible daily exposures
(PDEs), derived for some chemicals that
are considered to be mutagens and
carcinogens and, are also commonly
used in the synthesis of pharmaceuticals
or are, useful examples to illustrate the
principles for deriving compoundspecific intakes described in ICH M7.
This document is intended to provide
guidance for new drug substances and
new drug products during their clinical
development and subsequent
applications for marketing.
DATES: The announcement of the
guidance is published in the Federal
Register on March 14, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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]]>Agencies
[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
