[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58313-58314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1041]


Fibromyalgia Public Meeting on Patient-Focused Drug Development

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) is announcing a public 
meeting and an opportunity for public comment on Patient-Focused Drug 
Development for fibromyalgia. Patient-Focused Drug Development is part 
of FDA's performance commitments in 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 
fibromyalgia on daily life as well as the available therapies for 
fibromyalgia.

DATES: The public meeting will be held on December 10, 2013, from 1 
p.m. to 5 p.m. Registration to attend the meeting must be received by 
November 27, 2013. See the SUPPLEMENTARY INFORMATION section for 
information on how to register for the meeting. Submit electronic or 
written comments by February 10, 2013.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, in Section A of the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
meeting participants 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.
    Submit electronic comments to www.regulations.gov. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.
    FDA will post the agenda approximately 5 days before the meeting 
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm363203.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected fibromyalgia as the focus of a meeting under 
Patient-Focused Drug Development, an initiative that involves obtaining 
a better understanding of patients' perspectives on the severity of the 
disease and the available therapies for the condition. Patient-Focused 
Drug Development is being conducted to fulfill FDA's performance 
commitments made as part of the authorization of PDUFA V under Title I 
of the Food and Drug 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 has committed to obtain the patient perspective in twenty 
disease areas during the course of PDUFA V. For each disease area, the 
Agency will conduct 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 community, and other 
interested stakeholders.
    On April 11, 2013, FDA published a notice (78 FR 08441) in the 
Federal Register announcing the disease areas for meetings in fiscal 
years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V 
timeframe. To develop the list of disease areas, the Agency used 
several criteria that were outlined in the April 11 notice. The Agency 
obtained public comment on these criteria and potential disease areas 
through a notice for public comment published in the Federal Register 
on September 24, 2012 (77 FR 23454, and through a public meeting held 
on October 25, 2012. In selecting the disease areas, FDA carefully 
considered the public comments received and the perspectives of its 
review divisions. By the end of FY 2015, FDA will initiate another 
public process for determining the disease areas for FY 2016-2017. More 
information, including the list of disease areas and a general schedule 
of meetings, is posted on FDA's Web site 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 symptoms of fibromyalgia that 
matter most to patients and on current approaches to treating 
fibromyalgia. Fibromyalgia is a chronic disorder characterized by 
widespread musculoskeletal pain and tenderness in multiple tender 
points and may be accompanied by fatigue, sleep disturbances, irritable 
bowel syndrome, headache, and mood disorders. While there is currently 
no definitive cure, treatments for fibromyalgia include medications and 
lifestyle changes with emphasis on minimizing symptoms and improving 
general health and daily function. FDA is interested in obtaining a 
better understanding of fibromyalgia patients' perspectives on the 
severity of the disease and the available therapies used to treat 
fibromyalgia and its symptoms.
    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 patient panel discussion will begin the 
dialogue, followed by a facilitated discussion inviting comments from

[[Page 58314]]

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 that 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 experience because of your 
condition, which 1-3 symptoms have the most significant impact on your 
life? (Examples may include chronic pain, fatigue, difficulty 
concentrating, sleep disorders, 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 
condition? (Examples of activities may include sleeping through the 
night, daily hygiene, driving, household chores, etc.)
    (a) How do your symptoms and their negative impacts affect your 
daily life on the best days? On the worst days?
    (3) How have your condition and its symptoms changed over time?
    (a) Do your symptoms come and go? If so, do you know of anything 
that makes your symptoms better? Worse?
    (4) What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treating 
Fibromyalgia
    (1) What are you currently doing to help treat your condition or 
its symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such 
as exercise or acupuncture)
    (a) What specific symptoms do your treatments address?
    (b) How has your treatment regimen changed over time, and why?
    (2) How well does your current treatment regimen treat the most 
significant symptoms of your disease?
    (a) How well do these treatments improve your ability to do 
specific activities that are important to you in your daily life?
    (b) 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, and how do they affect your daily life? (Examples of 
downsides may include bothersome side effects, going to the hospital 
for treatment, restrictions on driving, etc.)
    (4) What specific things would you look for in an ideal treatment 
for your condition?

B. Meeting Attendance and/or Participation

    If you wish to attend this meeting, visit https://patientfocusedfibromyalgia.eventbrite.com. Please register by November 
27, 2013. Those who are unable to attend the meeting in person can 
register to view a live webcast of the meeting. You will be asked to 
indicate in your registration whether you plan to attend in person or 
via the webcast. Your registration should also contain your complete 
contact information, including name, title, affiliation, address, email 
address, and phone number.
    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 disability, please contact Graham 
Thompson (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 will 
also be asked to send a brief summary of responses to the topic 
questions to [email protected]. Panelists will be notified of 
their selection soon after the close of registration on November 27, 
2013. FDA 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.
    Interested members of the public, including those who attend the 
meeting in person or through the webcast, are invited to provide 
electronic or written responses to the questions pertaining to Topics 1 
and 2 to the public docket (see ADDRESSES). Comments may be submitted 
until February 10, 2013.

    Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23019 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P