82 FR 12611 - Public Meeting on Patient-Focused Drug Development for Autism; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 42 (March 6, 2017)

Page Range		12611-12613
FR Document		2017-04229

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.

Federal Register, Volume 82 Issue 42 (Monday, March 6, 2017)

[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12611-12613]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04229]


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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.

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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 http://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.thefederalregister.org/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: http://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, [email protected].

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 http://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 http://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 
[email protected] 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 http://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

Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices 12613

(b) How do you/your child weigh the Dated February 28, 2017. 355(j)(7)), which requires FDA to
potential benefits of these treatments Leslie Kux, publish a list of all approved drugs.
versus the common side effects of the Associate Commissioner for Policy. FDA publishes this list as part of the
treatments? (Common side effects could [FR Doc. 2017–04229 Filed 3–3–17; 8:45 am] ‘‘Approved Drug Products With
include headache, nausea, fatigue, BILLING CODE 4164–01–P
Therapeutic Equivalence Evaluations,’’
weight gain) which is known generally as the
(c) How do you/your child weigh ‘‘Orange Book.’’ Under FDA regulations,
potential benefits of these treatments DEPARTMENT OF HEALTH AND drugs are removed from the list if the
versus the less common but serious HUMAN SERVICES Agency withdraws or suspends
risks associated with the treatments? approval of the drug’s NDA or ANDA
(Examples of less common but serious Food and Drug Administration for reasons of safety or effectiveness, or
risks are infections, organ damage or if FDA determines that the listed drug
failure, suicidal thoughts) [Docket No. FDA–2016–P–1725]
was withdrawn from sale for reasons of
III. Meeting Attendance and Determination That FLONASE safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
Participation (Fluticasone Propionate) Nasal Spray,
determine, or the Agency may
If you wish to attend this meeting, 0.05 Milligram, Was Not Withdrawn
determine on its own initiative, whether
visit https://autismpfdd.eventbrite.com. From Sale for Reasons of Safety or
a listed drug was withdrawn from sale
Persons interested in attending this Effectiveness
for reasons of safety or effectiveness.
public meeting must register by April AGENCY: Food and Drug Administration, This determination may be made at any
24, 2017. If you are unable to attend the HHS. time after the drug has been withdrawn
meeting in person, you can register to from sale, but must be made prior to
ACTION: Notice.
view a live Webcast of the meeting. You approving an ANDA that refers to the
will be asked to indicate in your SUMMARY: The Food and Drug listed drug (§ 314.161 (21 CFR 314.161)).
registration if you plan to attend in Administration (FDA or Agency) has FDA may not approve an ANDA that
person or via the Webcast. Registration determined that prescription FLONASE does not refer to a listed drug.
is free and based on space availability, (fluticasone propionate) Nasal Spray, Prescription FLONASE (fluticasone
with priority given to early registrants. 0.05 milligram (mg), was not withdrawn propionate) Nasal Spray, 0.05 mg, is the
Early registration is recommended from sale for reasons of safety or subject of NDA 020121, held by
because seating is limited; therefore, effectiveness. This determination means GlaxoSmithKline, and initially
FDA may limit the number of that FDA will not begin procedures to approved on October 19, 1994.
participants from each organization. withdraw approval of abbreviated new FLONASE is indicated for the
Registrants will receive confirmation drug applications (ANDAs) that refer to management of the nasal symptoms of
once they have been accepted. Onsite this drug product, and this perennial nonallergic rhinitis in adult
registration on the day of the meeting determination will allow FDA to and pediatric patients aged 4 years and
will be based on space availability. If continue to approve ANDAs for older.
you need special accommodations fluticasone propionate nasal spray, 0.05 In a letter dated May 25, 2016,
because of a disability, please contact mg, if all other legal and regulatory GlaxoSmithKline notified FDA that
Shanon Woodward (see FOR FURTHER requirements are met. prescription FLONASE (fluticasone
INFORMATION CONTACT) at least 7 days propionate) Nasal Spray, 0.05 mg, was
before the meeting. FOR FURTHER INFORMATION CONTACT:
being discontinued, and FDA moved the
Patients and patient representatives David Faranda, Center for Drug drug product to the ‘‘Discontinued Drug
who are interested in presenting Evaluation and Research, Food and Product List’’ section of the Orange
comments as part of the initial panel Drug Administration, 10903 New Book.
discussions will be asked to indicate in Hampshire Ave., Bldg. 51, Rm. 6208, Lachman Consultant Services, Inc.,
their registration which topic(s) they Silver Spring, MD 20993–0002, 301– submitted a citizen petition dated June
wish to address. These patients and 796–8767. 20, 2016 (Docket No. FDA–2016–P–
patient representatives also must send SUPPLEMENTARY INFORMATION: In 1984, 1725), under 21 CFR 10.30, requesting
to PatientFocused@fda.hhs.gov a brief Congress enacted the Drug Price that the Agency determine whether
summary of responses to the topic Competition and Patent Term prescription FLONASE (fluticasone
questions by April 17, 2017. Panelists Restoration Act of 1984 (Pub. L. 98–417) propionate) Nasal Spray, 0.05 mg, was
will be notified of their selection (the 1984 amendments), which withdrawn from sale for reasons of
approximately 7 days before the public authorized the approval of duplicate safety or effectiveness.
meeting. We will try to accommodate all versions of drug products under an After considering the citizen petition
patients and patient representatives who ANDA procedure. ANDA applicants and reviewing Agency records and
wish to speak, either through the panel must, with certain exceptions, show that based on the information we have at this
discussion or audience participation; the drug for which they are seeking time, FDA has determined under
however, the duration of comments may approval contains the same active § 314.161 that prescription FLONASE
be limited by time constraints. ingredient in the same strength and (fluticasone propionate) Nasal Spray,
Transcripts: Please be advised that as dosage form as the ‘‘listed drug,’’ which 0.05 mg, was not withdrawn for reasons
soon as a transcript is available, it will is a version of the drug that was of safety or effectiveness. The petitioner
asabaliauskas on DSK3SPTVN1PROD with NOTICES

be accessible at https:// previously approved. ANDA applicants has identified no data or other
www.regulations.gov. It may be viewed do not have to repeat the extensive information suggesting that this drug
at the Division of Dockets Management clinical testing otherwise necessary to product was withdrawn for reasons of
(see ADDRESSES). A link to the transcript gain approval of a new drug application safety or effectiveness. We have
will also be available on the Internet at (NDA). carefully reviewed our files for records
http://www.fda.gov/ForIndustry/ The 1984 amendments include what concerning the withdrawal of
UserFees/PrescriptionDrugUserFee/ is now section 505(j)(7) of the Federal prescription FLONASE (fluticasone
ucm529043.htm. Food, Drug, and Cosmetic Act (21 U.S.C. propionate) Nasal Spray, 0.05 mg, from

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Document Created: 2017-03-04 00:06:46
Document Modified: 2017-03-04 00:06:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public meeting; request for comments.
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.
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, [email protected]
FR Citation		82 FR 12611

82 FR 12611 - Public Meeting on Patient-Focused Drug Development for Autism; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 42 (March 6, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration