[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Notices]
[Pages 38539-38541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-N-2014-0865]
Patient-Focused Drug Development for Idiopathic Pulmonary
Fibrosis; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
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 idiopathic pulmonary fibrosis. 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 idiopathic pulmonary fibrosis on
daily life as well as patient views on treatment approaches for
idiopathic pulmonary fibrosis.
DATES: The public meeting will be held on September 26, 2014, from 1
p.m. to 5 p.m. Registration to attend the meeting
[[Page 38540]]
must be received by September 10, 2014 (see SUPPLEMENTARY INFORMATION
for instructions). Submit electronic or written comments by November
26, 2014.
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. Participants must enter
through Building 1 and undergo security screening. 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 http://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/ucm395774.htm.
FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1144, Silver Spring, MD 20993, 301-796-
0684, FAX: 301-847-8443, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA has selected idiopathic pulmonary fibrosis 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 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 on the FDA Web site at
http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA committed to obtain the patient perspective on 20 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 communities, 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 time
frame. The Agency used several criteria outlined in the April 11 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. By the end of FY 2015, FDA will initiate a second 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. Purpose and Scope of Meeting
The purpose of this Patient-Focused Drug Development meeting is to
obtain input on the symptoms and other impacts of idiopathic pulmonary
fibrosis that matter most to patients, as well as perspectives on
current approaches to treating idiopathic pulmonary fibrosis. FDA
expects that this information will come directly from patients,
caregivers, and patient advocates. Idiopathic pulmonary fibrosis is a
rare and life-threatening disease in which lung tissue become scarred
over time. Many people with idiopathic pulmonary fibrosis survive only
3 to 5 years from the time of diagnosis. Symptoms of idiopathic
pulmonary fibrosis can include shortness of breath, dry cough, fatigue,
and chest pain. There is no cure for idiopathic pulmonary fibrosis;
symptomatic treatment options include corticosteroids, oxygen therapy,
pulmonary rehabilitation, and lifestyle changes.
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: Symptoms and Daily Impacts That Matter Most to Patients
Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include shortness of breath, cough,
fatigue, etc.)
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 household chores,
walking up the stairs, etc.)
[cir] How do your symptoms and their negative impacts affect your
daily life on the best days?
[cir] How do your symptoms and their negative impacts affect your
daily life on the worst days?
How has your condition and its symptoms changed over time?
Topic 2: Patient Perspectives on Treatment Approaches
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 diet modification.) How well does your current treatment
regimen treat the most significant symptoms of your disease?
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, etc.)
Because there is no complete cure for your condition, what
specific things would you look for in an ideal treatment for your
condition?
III. Attendance and Participation
If you wish to attend this meeting, visit http://patientfocusedIPF.eventbrite.com. Please register by September 10, 2014. If you are
unable to attend the meeting in person, you can register to view a live
Web cast of the meeting. You will be asked to indicate in your
registration if you plan to attend in person or via the Web cast. Your
registration will also contain your complete contact information,
including name, title, affiliation, address, email address, and phone
number. Seating will be limited, so early registration is
[[Page 38541]]
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 Pujita
Vaidya (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. They will be asked to
send a brief summary of responses to the topic questions to
[email protected]. Panelists will be notified of their
selection a few days after the close of registration on September 10,
2014. FDA will try to accommodate all patients and patient advocate
participants who wish to speak, either through the panel discussion or
audience participation; however, the duration of comments may be
limited by time constraints.
IV. Comments
Submit electronic or written responses to the questions pertaining
to Topics 1 and 2 to the public docket (see ADDRESSES) by November 26,
2014. 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.
V. Transcripts
As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm395774.htm.
Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15871 Filed 7-7-14; 8:45 am]
BILLING CODE 4164-01-P