[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Pages 75822-75824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2137]


Public Meeting on Patient-Focused Drug Development for Breast 
Cancer; 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 or Agency) is announcing 
a public meeting and an opportunity for public comment on patient-
focused drug development for breast cancer. Patient-focused drug 
development is part of FDA's

[[Page 75823]]

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 
breast cancer on daily life and patient views on treatment approaches.

DATES: The public meeting will be held on April 2, 2015, from 1 p.m. to 
5 p.m. Registration to attend the meeting must be received by March 23, 
2015 (see SUPPLEMENTARY INFORMATION for instructions). Submit 
electronic or written comments to the public docket by June 2, 2015.

ADDRESSES: The 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. 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 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/Drugs/NewsEvents/ucm421313.htm.

FOR FURTHER INFORMATION CONTACT: Pegah Mariani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 240-402-
4513, FAX: 301-847-8443, <a href="/cdn-cgi/l/email-protection#fdae9c848498999895d3b09c8f949c9394bd9b999cd395958ed39a928b"><span class="__cf_email__" data-cfemail="0457657d7d6160616c2a4965766d656a6d446260652a6c6c772a636b72">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected breast cancer 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) (Public Law 112-144). The full set of 
performance commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtaining 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 document 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. 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 at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    The purpose of this patient-focused drug development meeting is to 
obtain input on the symptoms and other impacts of breast cancer that 
matter most to patients, as well as perspectives on current approaches 
to treating breast cancer. FDA expects that this information will come 
directly from patients, caregivers, and patient advocates. Breast 
cancer is a disease that can occur in both men and women, caused by an 
uncontrolled growth of cells in breast tissue. Most breast cancers 
arise from cells lining the ducts or lobules of the breast. The cancer 
may spread locally to lymph nodes or distantly to various organs (i.e., 
bone, liver, brain). Treatment for breast cancer differs depending on 
the extent of disease and may include a combination of surgery, 
radiation therapy, conventional chemotherapy, hormonal therapy and/or 
targeted drug therapy. In addition to prescription medicines, 
complementary and alternative therapies are available to help manage 
the side effects of breast cancer treatments.
    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
    1. For context, how long ago was your diagnosis of breast cancer? 
Is your cancer currently in only one area or has it spread to other 
parts of the breast or lymph nodes or outside of the breast?
    2. Of all the symptoms that you experience because of your breast 
cancer, which one to three symptoms have the most significant impact on 
your daily life? (Examples may include breast pain, swelling, bone 
pain, and fatigue.)
    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 breast 
cancer? (Examples may include exercise, sexual activity/intimacy, etc.)
Topic 2: Patient Perspectives on Current Approaches To Treating Breast 
Cancer
    1. Are you currently undergoing any cancer treatments to help 
reduce or control the spread of your breast 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 breast 
cancer? Please include any prescription medicines, over-the-counter 
products, and other therapies including non-drug therapies (such as 
pain medication, acupuncture, massage therapy, and dietary 
supplements).

[[Page 75824]]

    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 breast cancer?
    4. What factors do you take into account when making decisions 
about using treatments to help reduce or control the spread of your 
breast 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 the 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. Meeting Attendance and Participation

    If you wish to attend this meeting, visit http://breastcancerpatientfocused.eventbrite.com. Please register by March 23. 
2015. 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 Pegah 
Mariani (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 <a href="/cdn-cgi/l/email-protection#5808392c313d362c1e373b2d2b3d3c183e3c397630302b763f372e"><span class="__cf_email__" data-cfemail="eaba8b9e838f849eac85899f998f8eaa8c8e8bc4828299c48d859c">[email protected]</span></a> a brief summary of responses to 
the topic questions by March 16, 2015. 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 June 2, 2015. 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/Drugs/NewsEvents/ucm421313.htm.

    Dated: December 15, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29721 Filed 12-18-14; 8:45 am]
BILLING CODE 4164-01-P


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