[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22606-22608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1110]


Public Meeting on Patient-Focused Drug Development for 
Neuropathic Pain Associated With Peripheral Neuropathy

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 or Agency) is announcing 
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for neuropathic pain associated with 
peripheral neuropathies. 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 
neuropathic pain associated with peripheral neuropathies, patient views 
on treatment approaches, and decision factors taken into account when 
selecting a treatment.

DATES: The public meeting will be held on June 10, 2016, from 10 a.m. 
to 4 p.m. Registration to attend the meeting must be received by June 
3, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit 
electronic or

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written comments to the public docket by August 10, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2016-N-1110 for ``Public Meeting on Patient-Focused Drug 
Development for Neuropathic Pain Associated with Peripheral 
Neuropathy.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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/ucm470608.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 neuropathic pain associated with peripheral 
neuropathy 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 (FDASIA) (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 21613) 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 (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 http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain 
patient and patient stakeholder input on the impacts of neuropathic 
pain associated with peripheral neuropathies. Peripheral neuropathy is 
a neurological disorder that develops as a result of damage to the 
peripheral nerves and is

[[Page 22608]]

associated with both a physical and psychological burden. Nerve damage 
can be caused by diseases such as diabetes, physical injury, or 
exposure to drugs or toxins. The pain associated with neuropathies of 
sensory nerves may be characterized as a pins and needles sensation, as 
sharp, jabbing, or burning, or as an exaggeratedly intense or distorted 
pain response to typically nonpainful touch. While there is currently 
no cure, treatments for the pain associated with peripheral neuropathy 
include prescription medications and other approaches such as 
transcutaneous electrical nerve stimulation, braces, and behavioral 
therapies. FDA is interested in the perspectives of patients with 
peripheral neuropathy on specifically: (1) The impact of neuropathic 
pain associated with peripheral neuropathy and (2) treatment approaches 
for the neuropathic pain associated with peripheral neuropathy.
    The questions that will be asked of patients and patient 
stakeholders at the meeting are listed in this section, 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 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. How would you describe your neuropathic pain associated with 
peripheral neuropathy? What terms would you use to describe the most 
bothersome aspects of pain? (Examples may include stabbing sensations, 
electric shocks, burning or tingling, etc.)
    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 
neuropathic pain? (Examples of activities may include sleeping through 
the night, daily hygiene, participation in sports or social activities, 
intimacy with a spouse or partner, etc.)
    3. How do your neuropathic pain and its negative impacts affect 
your daily life on the best days? On the worst days?
    4. How has your neuropathic pain changed over time?
    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 neuropathic pain 
associated with peripheral neuropathy? (Examples may include 
prescription medicines, over-the-counter products, and other therapies 
including non-drug therapies). How has your treatment regimen changed 
over time, and why?
    2. How well does your current treatment regimen control your 
neuropathic pain?
    a. How well have these treatments worked for you as your condition 
has changed over time?
    b. Would you define your condition today as being well managed?
    3. What are the most significant downsides to your current 
treatments, and how do they affect your daily life? (Examples of 
downsides may include bothersome side effects, going to the hospital or 
clinic for treatment, time devoted to treatment, restrictions on 
driving, etc.)
    4. Assuming there is no complete cure for your neuropathic pain, 
what specific things would you look for in an ideal treatment for your 
neuropathic pain? What would you consider to be a meaningful 
improvement in your condition (for example, specific symptom 
improvements or functional improvements) that a treatment could 
provide?
    5. If you had the opportunity to consider participating in a 
clinical trial studying experimental treatments for neuropathic pain, 
what things would you consider when deciding whether or not to 
participate? (Examples may include how severe your neuropathic pain is, 
how well current treatments are working for you, your concern about 
risks, etc.)

B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://peripheralneuropathypfdd.eventbrite.com. Please register by June 3, 
2016. 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. Seating will be limited, so early registration is 
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from 
each organization based on space limitations. 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 Meghana 
Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before 
the meeting.
    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 May 27, 2016. 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.
    Docket Comments: Regardless of whether you attend the public 
meeting, you can submit electronic or written responses to the 
questions pertaining to topics 1 and 2 to the public docket (see 
ADDRESSES) by August 10, 2016. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: As soon as a transcript is available, FDA will post it 
at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

    Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08881 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P