[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28665-28667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3067]


Patient-Focused Drug Development for Alopecia Areata; Public 
Meeting; 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 Alopecia Areata.'' Patient-
Focused Drug Development is part of FDA's performance commitments under 
the fifth authorization of the Prescription Drug User Fee Act (PDUFA 
V). The public meeting is intended to allow FDA to obtain patients' 
perspectives on the impact of alopecia areata, including on daily life. 
FDA is also seeking patients' views on treatment approaches and 
decision factors taken into account when selecting a treatment.

DATES: The public meeting will be held on September 11, 2017, from 1 
p.m. to 5 p.m. Submit either electronic or written comments on this 
public meeting by November 13, 2017. 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. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before November 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-3067 for ``Patient-Focused Drug Development for Alopecia 
Areata.'' 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

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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.
    FDA will post the agenda approximately 5 days before the meeting 
at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm.

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 on Patient-Focused Drug Development

    FDA has selected alopecia areata as the focus of a public meeting 
under the Patient-Focused Drug Development initiative. This initiative 
involves obtaining a better understanding of patients' 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 PDUFA 
reauthorization under Title I of the Food and Drug Administration 
Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of 
performance commitments is available on the FDA Web site 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 benefits 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 21613), announcing the disease areas for meetings in fiscal 
years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V 
timeframe. 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 (80 FR 38216), 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 
patient and patient stakeholder input on the symptoms of alopecia 
areata that matter most to patients and on current approaches to 
treating alopecia areata. Alopecia areata is an autoimmune disease that 
causes hair loss. The hair loss usually occurs on the scalp but can 
also affect the beard, eyebrows, and other areas of the body. While 
there is currently no cure, there are available treatments, such as 
corticosteroids or non-drug therapies, which may help hair regrowth. 
FDA is interested in the perspectives of patients with alopecia areata 
on: (1) The impact of their condition, (2) treatment approaches, and 
(3) decision factors taken into account when selecting a treatment.
    The questions that will be asked of patients and patient 
stakeholders at the meeting are listed in this 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 stakeholder 
participants. In addition to input generated through this public 
meeting, FDA is interested in receiving patient input addressing these 
questions through electronic or written comments, which can be 
submitted to the Dockets Management Staff (see ADDRESSES).

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to 
Patients

    1. Of all the symptoms or disease manifestations that you 
experience because of your condition, which one to three symptoms or 
manifestations have the most significant impact on your life? Examples 
may include location or type of hair loss (i.e. loss of hair on scalp, 
loss of eyebrows, loss of all hair on body patchy hair loss), nail 
changes, hair quality upon regrowth.
    2. Are there specific activities that are important to you but that 
you cannot do at all or as fully as you would like because of your 
condition? Examples of activities may include daily hygiene, engagement 
in personal relationships, participation in sports or social 
activities, completion of school or work activities, etc.
    3. How do your symptoms and their negative impacts affect your 
daily life on the best days? On the worst days?
    4. How has your condition changed over time?
     Would you define your condition today as being well-
managed?
    5. What worries you most about your condition?

Topic 2: Patients' Perspectives on Current Approaches to Treatment

    1. What are you currently doing to help treat your condition or its 
symptoms? Examples may include prescription medicines, over-the-counter 
products, and non-drug therapies such as diet modification.
     How has your treatment regimen changed over time, and why?
    2. How well does your current treatment regimen control your 
condition?
     How well have these treatments worked for you as your 
condition has changed over time?
    3. What are the most significant downsides to your current 
treatments,

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and how do they affect your daily life? Examples of downsides may 
include going to the clinic for treatment, time devoted to treatment, 
side effects of treatment, route of administration, etc.
    4. What specific things would you look for in an ideal treatment 
for your condition?
     What would you consider to be a meaningful improvement in 
your condition that a treatment could provide?
    5. What factors do you take into account when making decisions 
about selecting a course of treatment?

III. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://alopeciaareata.eventbrite.com. Persons interested in attending this 
public meeting must register by August 28, 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. 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 due to a disability, please contact Meghana 
Chalasani (see FOR FURTHER INFORMATION CONTACT) no later than September 
1, 2017.
    Patients 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 also 
must send to [email protected] a brief summary of responses to 
the topic questions by August 21, 2017. 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.
    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 at 
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm.

    Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13194 Filed 6-22-17; 8:45 am]
 BILLING CODE 4164-01-P