Public Meeting on Patient-Focused Drug Development for Autism; Request for Comments, 12611-12613 [2017-04229]
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Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
on the collection of information by May
5, 2017.’’
Under the ADDRESSES section, page
11471, column two, correct the notice to
read: ‘‘Submit electronic comments on
the collection of information to:
cilpprcomments@acl.hhs.gov’’.
Under the heading ‘‘New
Requirements’’, the first paragraph, page
11472, column one, replace the first
paragraph with the following paragraph
below:
‘‘The Workforce Innovation and
Opportunity Act (WIOA), enacted on July 22,
2014, added a new core service to the list of
‘‘independent living core services’’ that ACL
funded Centers for Independent Living (CILs)
are required to provide. Prior to WIOA, CILs
were required to provide the following core
services: (1) Information and referral services;
(2) independent living skills training; (3) peer
counseling, including cross-disability peer
counseling; (4) and individual and systems
advocacy. WIOA added additional
‘‘transition and diversion’’ core services
comprised of three components. It requires
CILs to:’’.
Dated: February 24, 2017.
Daniel P. Berger,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–04169 Filed 3–3–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–0136]
Public Meeting on Patient-Focused
Drug Development for Autism;
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 a public meeting and
an opportunity for public comment on
Patient-Focused Drug Development for
autism. Patient-Focused Drug
Development is part of FDA’s
performance commitments made as part
of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to
allow FDA to obtain patient
perspectives on the impact of autism on
daily life as well as patient views on
treatment approaches for autism.
DATES: The public meeting will be held
on May 4, 2017, from 1 p.m. to 5 p.m.
Registration to attend the meeting must
be received by April 24, 2017 (see
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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19:24 Mar 03, 2017
Jkt 241001
The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
ADDRESSES:
Electronic Submissions
Food and Drug Administration
AGENCY:
SUPPLEMENTARY INFORMATION for
instructions). Submit either electronic
or written comments on the public
meeting by July 5, 2017. Late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before July 5, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of July
5, 2016. 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. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
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’’).
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12611
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2017–N–0136 for ‘‘Public Meeting on
Patient-Focused Drug Development for
Autism.’’ Received comments, those
filed in a timely manner (see DATES),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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
E:\FR\FM\06MRN1.SGM
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12612
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm529043.htm.
FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Shanon Woodward, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1141,
Silver Spring, MD 20993–0002, 240–
402–6167, FAX: 301–847–8443,
shanon.woodward@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected autism as the focus
of a public meeting under PatientFocused Drug Development, an
initiative that involves obtaining a better
understanding of patient perspectives
on the severity of a disease and the
available therapies for that condition.
Patient-Focused Drug Development is
being conducted to fulfill FDA
performance commitments that are part
of the reauthorization of the PDUFA
under Title I of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144). The full set of
performance commitments is available
at https://www.fda.gov/downloads/
forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA committed to obtain the patient
perspective on at least 20 disease areas
during the course of PDUFA V. For each
disease area, the Agency is conducting
a public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
communities, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice in the Federal Register (78 FR
08441) announcing the disease areas for
meetings in fiscal years (FYs) 2013–
2015, the first 3 years of the 5-year
PDUFA V time frame. The Agency used
several criteria outlined in that notice to
develop the list of disease areas. FDA
obtained public comment on the
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Agency’s proposed criteria and potential
disease areas through a public docket
and a public meeting that was convened
on October 25, 2012. In selecting the set
of disease areas, FDA carefully
considered the public comments
received and the perspectives of review
divisions at FDA. FDA initiated a
second public process for determining
the disease areas for FY 2016–2017, and
published a notice in the Federal
Register on July 2, 2015, announcing the
selection of eight disease areas. More
information, including the list of disease
areas and a general schedule of
meetings, is posted at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm347317.htm.
II. Purpose and Scope of the Meeting
As part of Patient-Focused Drug
Development, FDA will obtain input of
patients and patient representatives on
the symptoms of autism that matter
most to patients and on current
approaches to treating autism. Autism is
a neurodevelopmental disorder
characterized in varying degrees by
difficulties with social interaction,
verbal and non-verbal communication
challenges, and repetitive behavior
patterns. FDA has approved products
for irritability related to autism
including risperidone and aripiprazole.
In addition to pharmacological
treatments, behavioral and educational
interventions are also common
treatment options. FDA is interested in
the perspectives of patients with autism
and caregivers on (1) symptoms and the
daily impacts of their condition, (2)
current approaches to treatment, and (3)
decision factors taken into account
when selecting a treatment.
The questions that will be asked of
patients and patient representatives at
the meeting are listed in this section,
organized by topic. For each topic, a
brief initial patient/caregiver 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
input addressing these questions
through written comments, which can
be submitted to the public docket (see
ADDRESSES).
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
(1) Of all the symptoms that you/your
child experiences because of the
condition, which 1–3 symptoms have
the most significant impact on your/
your child’s life? (Examples may
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include behavioral symptoms, difficulty
with motor coordination, difficulty
sleeping, difficulty concentrating,
seizures, etc.)
(2) Are there specific activities that
are important to you/your child but that
you/your child cannot do at all or as
fully as you would like because of these
symptoms? (Examples of activities may
include sleeping through the night,
daily hygiene, eating, dressing,
participation in sports or social
activities, etc.)
(a) How do these symptoms and their
negative impacts affect daily life on the
best days? On the worst days?
(3) How has your/your child’s
condition and its symptoms changed
over time?
(4) What worries you/your child most
about your/your child’s condition?
Topic 2: Patients’ Perspectives on
Current Approaches to Treating
(1) What are you/your child currently
doing to help treat the condition or its
symptoms? (Examples may include
prescription medicines, over-thecounter products, and other therapies
including non-drug therapies such as
behavioral interventions)
(a) How has your/your child’s
treatment regimen changed over time,
and why?
(2) How well does your/your child’s
current treatment regimen treat the most
significant symptoms of the condition?
(a) How well do your/your child’s
treatments address specific activities
that are important to you/your child’s
daily life?
(b) How well have these treatments
worked for you/your child as the
condition has changed over time?
Which symptoms are not addressed as
well?
(3) What are the most significant
downsides to your/your child’s current
treatments, and how do they affect your
daily life? (Examples of downsides may
include bothersome side effects,
interacts with other medications, time
devoted to treatment, etc.)
(4) What specific things would you
look for in an ideal treatment for your/
your child’s condition?
(a) What would you consider to be a
meaningful improvement (for example
symptom improvements or functional
improvements) in your/your child’s
condition that a treatment could
provide?
(5) What factors do you/your child
take into account when making
decisions about selecting a course of
treatment?
(a) What information on potential
benefits of these treatments factors most
into your/your child’s decision?
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Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(b) How do you/your child weigh the
potential benefits of these treatments
versus the common side effects of the
treatments? (Common side effects could
include headache, nausea, fatigue,
weight gain)
(c) How do you/your child weigh
potential benefits of these treatments
versus the less common but serious
risks associated with the treatments?
(Examples of less common but serious
risks are infections, organ damage or
failure, suicidal thoughts)
Dated February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
III. Meeting Attendance and
Participation
If you wish to attend this meeting,
visit https://autismpfdd.eventbrite.com.
Persons interested in attending this
public meeting must register by April
24, 2017. 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.
Early registration is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meeting
will be based on space availability. If
you need special accommodations
because of a disability, please contact
Shanon Woodward (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
Patients and 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 and
patient representatives also must send
to PatientFocused@fda.hhs.gov a brief
summary of responses to the topic
questions by April 17, 2017. Panelists
will be notified of their selection
approximately 7 days before the public
meeting. We will try to accommodate all
patients and patient representatives who
wish to speak, either through the panel
discussion or audience participation;
however, the duration of comments may
be limited by time constraints.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A link to the transcript
will also be available on the Internet at
https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm529043.htm.
Determination That FLONASE
(Fluticasone Propionate) Nasal Spray,
0.05 Milligram, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
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[FR Doc. 2017–04229 Filed 3–3–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–1725]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that prescription FLONASE
(fluticasone propionate) Nasal Spray,
0.05 milligram (mg), was not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and this
determination will allow FDA to
continue to approve ANDAs for
fluticasone propionate nasal spray, 0.05
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
David Faranda, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 301–
796–8767.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
SUMMARY:
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12613
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness, or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, is the
subject of NDA 020121, held by
GlaxoSmithKline, and initially
approved on October 19, 1994.
FLONASE is indicated for the
management of the nasal symptoms of
perennial nonallergic rhinitis in adult
and pediatric patients aged 4 years and
older.
In a letter dated May 25, 2016,
GlaxoSmithKline notified FDA that
prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated June
20, 2016 (Docket No. FDA–2016–P–
1725), under 21 CFR 10.30, requesting
that the Agency determine whether
prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that prescription FLONASE
(fluticasone propionate) Nasal Spray,
0.05 mg, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that this drug
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, from
E:\FR\FM\06MRN1.SGM
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Agencies
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12611-12613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0136]
Public Meeting on Patient-Focused Drug Development for Autism;
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 a public meeting and an opportunity for public comment on
Patient-Focused Drug Development for autism. Patient-Focused Drug
Development is part of FDA's performance commitments made as part of
the fifth authorization of the Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to allow FDA to obtain patient
perspectives on the impact of autism on daily life as well as patient
views on treatment approaches for autism.
DATES: The public meeting will be held on May 4, 2017, from 1 p.m. to 5
p.m. Registration to attend the meeting must be received by April 24,
2017 (see SUPPLEMENTARY INFORMATION for instructions). Submit either
electronic or written comments on the public meeting by July 5, 2017.
Late, untimely filed comments will not be considered. Electronic
comments must be submitted on or before July 5, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 5, 2016. 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. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For more
information on parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-0136 for ``Public Meeting on Patient-Focused Drug
Development for Autism.'' Received comments, those filed in a timely
manner (see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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
[[Page 12612]]
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm529043.htm.
FOR FURTHER INFORMATION CONTACT: Shanon Woodward, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1141, Silver Spring, MD 20993-0002, 240-
402-6167, FAX: 301-847-8443, shanon.woodward@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected autism as the focus of a public meeting under
Patient-Focused Drug Development, an initiative that involves obtaining
a better understanding of patient perspectives on the severity of a
disease and the available therapies for that condition. Patient-Focused
Drug Development is being conducted to fulfill FDA performance
commitments that are part of the reauthorization of the PDUFA under
Title I of the Food and Drug Administration Safety and Innovation Act
(Pub. L. 112-144). The full set of performance commitments is available
at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA committed to obtain the patient perspective on at least 20
disease areas during the course of PDUFA V. For each disease area, the
Agency is conducting a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 08441) announcing the disease areas for meetings in fiscal years
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame.
The Agency used several criteria outlined in that notice to develop the
list of disease areas. FDA obtained public comment on the Agency's
proposed criteria and potential disease areas through a public docket
and a public meeting that was convened on October 25, 2012. In
selecting the set of disease areas, FDA carefully considered the public
comments received and the perspectives of review divisions at FDA. FDA
initiated a second public process for determining the disease areas for
FY 2016-2017, and published a notice in the Federal Register on July 2,
2015, announcing the selection of eight disease areas. More
information, including the list of disease areas and a general schedule
of meetings, is posted at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm.
II. Purpose and Scope of the Meeting
As part of Patient-Focused Drug Development, FDA will obtain input
of patients and patient representatives on the symptoms of autism that
matter most to patients and on current approaches to treating autism.
Autism is a neurodevelopmental disorder characterized in varying
degrees by difficulties with social interaction, verbal and non-verbal
communication challenges, and repetitive behavior patterns. FDA has
approved products for irritability related to autism including
risperidone and aripiprazole. In addition to pharmacological
treatments, behavioral and educational interventions are also common
treatment options. FDA is interested in the perspectives of patients
with autism and caregivers on (1) symptoms and the daily impacts of
their condition, (2) current approaches to treatment, and (3) decision
factors taken into account when selecting a treatment.
The questions that will be asked of patients and patient
representatives at the meeting are listed in this section, organized by
topic. For each topic, a brief initial patient/caregiver 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 input
addressing these questions through written comments, which can be
submitted to the public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
(1) Of all the symptoms that you/your child experiences because of
the condition, which 1-3 symptoms have the most significant impact on
your/your child's life? (Examples may include behavioral symptoms,
difficulty with motor coordination, difficulty sleeping, difficulty
concentrating, seizures, etc.)
(2) Are there specific activities that are important to you/your
child but that you/your child cannot do at all or as fully as you would
like because of these symptoms? (Examples of activities may include
sleeping through the night, daily hygiene, eating, dressing,
participation in sports or social activities, etc.)
(a) How do these symptoms and their negative impacts affect daily
life on the best days? On the worst days?
(3) How has your/your child's condition and its symptoms changed
over time?
(4) What worries you/your child most about your/your child's
condition?
Topic 2: Patients' Perspectives on Current Approaches to Treating
(1) What are you/your child currently doing to help treat the
condition or its symptoms? (Examples may include prescription
medicines, over-the-counter products, and other therapies including
non-drug therapies such as behavioral interventions)
(a) How has your/your child's treatment regimen changed over time,
and why?
(2) How well does your/your child's current treatment regimen treat
the most significant symptoms of the condition?
(a) How well do your/your child's treatments address specific
activities that are important to you/your child's daily life?
(b) How well have these treatments worked for you/your child as the
condition has changed over time? Which symptoms are not addressed as
well?
(3) What are the most significant downsides to your/your child's
current treatments, and how do they affect your daily life? (Examples
of downsides may include bothersome side effects, interacts with other
medications, time devoted to treatment, etc.)
(4) What specific things would you look for in an ideal treatment
for your/your child's condition?
(a) What would you consider to be a meaningful improvement (for
example symptom improvements or functional improvements) in your/your
child's condition that a treatment could provide?
(5) What factors do you/your child take into account when making
decisions about selecting a course of treatment?
(a) What information on potential benefits of these treatments
factors most into your/your child's decision?
[[Page 12613]]
(b) How do you/your child weigh the potential benefits of these
treatments versus the common side effects of the treatments? (Common
side effects could include headache, nausea, fatigue, weight gain)
(c) How do you/your child weigh potential benefits of these
treatments versus the less common but serious risks associated with the
treatments? (Examples of less common but serious risks are infections,
organ damage or failure, suicidal thoughts)
III. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://autismpfdd.eventbrite.com. Persons interested in attending this public
meeting must register by April 24, 2017. 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. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation once they have been accepted.
Onsite registration on the day of the meeting will be based on space
availability. If you need special accommodations because of a
disability, please contact Shanon Woodward (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the meeting.
Patients and 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 and patient representatives also must send to
PatientFocused@fda.hhs.gov a brief summary of responses to the topic
questions by April 17, 2017. Panelists will be notified of their
selection approximately 7 days before the public meeting. We will try
to accommodate all patients and patient representatives who wish to
speak, either through the panel discussion or audience participation;
however, the duration of comments may be limited by time constraints.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A link
to the transcript will also be available on the Internet at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm529043.htm.
Dated February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04229 Filed 3-3-17; 8:45 am]
BILLING CODE 4164-01-P