[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33851-33852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13243]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0596]


Lung Cancer Patient-Focused Drug Development; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting and an opportunity for public comment on Patient-Focused Drug 
Development for lung cancer. 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 patients' 
perspectives on the impact of lung cancer on daily life as well as the 
available therapies for lung cancer.

DATES: The public meeting will be held on June 28, 2013, from 8:30 a.m. 
to 12:30 p.m. Registration to attend the meeting must be received by 
June 19, 2013 (see SUPPLEMENTARY INFORMATION for instructions). Submit 
electronic or written comments by July 29, 2013.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting 
participants is through Building 1, where routine security checks will 
be performed. For parking and security information, 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 complete agenda and additional meeting background 
material approximately 5 days before the meeting at http://www.fda.gov/Forindustry/UserFees/PrescriptionDrugUserFee/ucm353273.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-
0684, FAX: 301-847-8443, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected lung cancer to be the focus of a public 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 
performance commitments made as part of the reauthorization 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 obtaining the patient perspective in 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 community, and other 
interested stakeholders.
    On April 11, 2013, FDA published a document (78 FR 21613) in the 
Federal Register that announced the disease areas for meetings in 
fiscal years (FY) 2013 to 2015, the first 3 years of the 5-year PDUFA V 
timeframe. The Agency used several criteria outlined in the April 11, 
2013, document to develop the list of disease areas. Public comment on 
the Agency's proposed criteria and potential disease areas was gathered 
through a Federal Register document for public comment that was 
published on September 24, 2012 (77 FR 58849), 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 public process for determining the disease areas for FY 
2016 and 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 gather 
patient and patient stakeholder input on symptoms of lung cancer that 
matter most to patients and on current approaches to treating lung 
cancer. Lung cancer is a disease caused by uncontrolled growth of 
abnormal cells in the tissues of the lung, usually in the cells lining 
air passages. Lung cancer cells can spread (metastasize) to almost

[[Page 33852]]

any other part of the body, such as to the brain or to bones. Available 
therapies for management of lung cancer falls into two main categories: 
therapies to reduce or control the spread of disease (including 
surgery, radiation therapy, conventional chemotherapy, and targeted 
therapies), and supportive care therapies to improve or manage symptoms 
of the underlying condition (lung cancer) or the side effects of cancer 
treatments. FDA is interested in patients' perspectives for the two 
main types of lung cancer (small-cell and non-small cell lung cancer) 
on the importance of disease symptoms, benefits of treatment 
approaches, and possible cancer treatment side effects.
    The draft questions that will be asked of patients and patient 
stakeholders at the meeting are provided in the paragraphs that follow. 
For each of these topics, a brief initial patient panel discussion will 
begin the dialogue and 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 the public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to 
Patients
    1. For context, how long ago was your diagnosis of lung cancer? Is 
your cancer currently in only one area of the lung or has it spread to 
other parts of the lung or outside of the lungs?
    2. Of all the symptoms that you experience because of your lung 
cancer, which one to three symptoms have the most significant impact on 
your daily life? (Examples may include pain, cough, shortness of 
breath, fatigue, voice hoarseness.)
    3. 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 lung 
cancer? (Examples may include sleeping through the night, climbing 
stairs, household activities.)
Topic 2: Patients' Perspectives on Current Approaches To Treating Lung 
Cancer
    1. Are you currently undergoing any cancer treatments to help 
reduce or control the spread of your lung cancer? Please describe.
    1.1 What do you consider to be the most significant downsides of 
these treatments? (Examples of downsides may include side effects, 
going to the hospital for treatment, frequent blood tests, etc.)
    1.2 How do these downsides affect your daily life?
    2. What supportive care treatments, if any, are you taking to help 
improve or manage the symptoms you experience because of your lung 
cancer? Please include any prescription medicines, over-the-counter 
products, and other therapies including non-drug therapies (such as 
breathing techniques).
    2.1 What specific symptoms do your treatments address?
    2.2 How well do these treatments manage these symptoms?
    2.3 Are there symptoms that your current treatment regimen does not 
address at all, or does not treat as well as you would like?
    3. When thinking about your overall goals for treatment, how do you 
weigh the importance of prolonging your life versus improving the 
symptoms you experience because of your lung cancer?
    4. What factors do you take into account when making decisions 
about using treatments to help reduce or control the spread of your 
lung cancer? In particular:
    4.1 What information on the potential benefits of these treatments 
factors most into your decision? (Examples of potential benefits from 
treatments may include shrinking the tumor, delaying the growth of the 
tumor, prolonging life, etc.)
    4.2 How do you weigh the potential benefits of these treatments 
versus the common side effects of the treatments? (Common side effects 
could include nausea, loss of appetite fatigue, diarrhea, rash.)
    4.3 How do you 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 developing a hole in the 
stomach or intestine, liver failure, kidney failure, lung inflammation, 
blood clot, stroke, heart attack, serious infections, etc.)

B. Attendance and/or Participation in the Meeting

    If you wish to attend this meeting, visit http://patientfocusedlungcancer.eventbrite.com. Please register by June 19, 
2013. Those who are unable to attend the meeting in person 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 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. More information will be posted on the 
meeting Web site at least 5 days before the meeting date.
    Patients who are interested in presenting comments as part of the 
initial panel discussions should 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(s) questions via email to 
[email protected]. Panelists will be notified of their 
selection soon after the close of registration on June 19, 2013. 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.
    Interested members of the public, including those who attend the 
meeting in person or through the Web cast, are invited to provide 
electronic or written responses to any or all of the questions 
pertaining to Topics 1 and 2 to the Division of Dockets Management (see 
ADDRESSES). Comments may be submitted until July 29, 2013.

    Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13243 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P