Public Meeting on Patient-Focused Drug Development for Breast Cancer; Request for Comments, 75822-75824 [2014-29721]
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75822
Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices
will be posted to the docket at https://
www.regulations.gov.
VI. References
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and is available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site address in this reference
section, but we are not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.)
1. FDA Guidance on Laser Products—
Conformance with IEC 60825–1 and
IEC 60601–2–22 (Laser Notice No.
50) (June 2007), available at https://
www.fda.gov/downloads/Medical
Devices/.../ucm094366.pdf.
Dated: December 15, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29725 Filed 12–18–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0128] (Formerly
Docket No. 2007D–0396)
Serious Drug-Induced Liver Injury: The
Importance of Getting It Right: How To
Measure and Interpret Drug-Induced
Liver Injury Information and Make
Correct Diagnoses; Public Conference;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public conference;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public conference entitled ‘‘Serious
Drug-Induced Liver Injury (DILI): The
Importance of Getting It Right: How to
Measure and Interpret DILI Information
and Make Correct Diagnoses.’’ This
conference will be cosponsored with the
Critical Path Institute (C-Path) and the
Pharmaceutical Research and
Manufacturers of America. The purpose
of the public conference is to discuss,
debate, and share views among
stakeholders in the pharmaceutical
industry, academia, health care
providers, patient groups, and
regulatory bodies on how best to detect
and assess the severity, extent, and
likelihood of drug causation of liver
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SUMMARY:
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injury and dysfunction in people using
drugs for any medical purpose.
DATES: The public conference will be
held on March 18, 2015, from 8 a.m. to
6 p.m. and on March 19, 2015, from 8
a.m. to 4 p.m.
ADDRESSES: The public conference will
be held at the College Park Marriott
Hotel & Conference Center, 3501
University Blvd., Hyattsville, MD 20783.
The hotel’s phone number is 301–985–
7300.
FOR FURTHER INFORMATION CONTACT:
Lana L. Pauls, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4478,
Silver Spring, MD 20993–0002, 301–
796–0518, email: lana.pauls@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2009, FDA announced the
availability of a guidance for industry
entitled ‘‘Drug-Induced Liver Injury:
Premarketing Clinical Evaluation’’ (74
FR 38035, July 30, 2009). This guidance
explains that DILI has been the most
frequent cause of safety-related drug
marketing withdrawals over the past 50
years and that hepatotoxicity has
limited the use of many drugs that have
been approved and has prevented the
approval of others. It discusses methods
of detecting DILI by periodic tests of
serum enzyme activities and bilirubin
concentration and how changes in the
results of those laboratory tests over
time, along with symptoms and physical
findings, may be used to estimate
severity of the injury. The guidance
suggests some ‘‘stopping rules’’ for
interrupting drug treatment and the
need to obtain sufficient clinical
information to assess causation. FDA
published a draft of this guidance in
2006, and comments on the draft were
taken into consideration when issuing
the final guidance in July 2009. FDA is
now interested in obtaining stakeholder
input on the issues addressed in this
guidance, including comments
regarding potential revisions to the
guidance.
II. Conference Information
The purpose of the 2015 conference is
to invite participants to present their
data and views, and to hold open
discussion.
A. Registration
A registration fee ($600 for industry
registrants and $300 for Federal
government and academic registrants)
will be charged to help defray the cost
of renting the meeting space, providing
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meals and snacks, covering the travel
fees incurred by invited academic (but
not government or industry) speakers,
and other expenses. The registration
process will be handled by C-Path, an
independent, nonprofit organization
established in 2005 with public and
private philanthropic support from the
southern Arizona community, Science
Foundation Arizona, and FDA.
Additional information on the
conference, program, and registration
procedures may be obtained on the
Internet at https://www.c-path.org and
https://www.fda.gov by typing ‘‘liver
toxicity’’ into the search box. (FDA has
verified the C-Path Web site address but
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
B. Transcripts
Please be advised that as soon as a
transcript is available of the public
conference, it can be obtained in either
hardcopy or on CD–ROM after
submission of a Freedom of Information
Act (FOIA) request. Written FOIA
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Material presented at past programs
(from 1999 to 2014) may be accessed at
www.aasld.org. Click on ‘‘Events and
Professional Development’’ and then
scroll down to ‘‘Drug-Induced Liver
Injury Conference.’’
Dated: December 15, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29720 Filed 12–18–14; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
E:\FR\FM\19DEN1.SGM
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Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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 https://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: https://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,
Sayyedeh.Mariani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected breast cancer as the
focus of a public meeting under patientfocused 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).
VerDate Sep<11>2014
19:37 Dec 18, 2014
Jkt 235001
The full set of performance
commitments is available at https://
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 https://
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
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75823
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).
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Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices
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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 https://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.
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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
PatientFocused@fda.hhs.gov 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 https://
www.regulations.gov.
Transcripts: As soon as a transcript is
available, FDA will post it at https://
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
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2013–0045]
Department of Homeland Security
(DHS) Cybersecurity Education and
Awareness (CE&A) National Initiative
for Cybersecurity Careers and Studies
(NICCS) Cybersecurity Scholarships,
Internships, Camps, Clubs, and
Competitions Collection
Cybersecurity Education &
Awareness Office, DHS.
ACTION: 60-day Notice and request for
comments; new collection (request for a
new OMB Control No.), 1601—NEW
AGENCY:
The Department of Homeland
Security, Cybersecurity Education &
Awareness Office, will submit the
following Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995 (Pub. L. 104–13, 44 U.S.C. Chapter
35).
SUMMARY:
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Comments are encouraged and
will be accepted until February 17,
2015. This process is conducted in
accordance with 5 CFR 1320.1.
ADDRESSES: You may submit comments,
identified by docket number 2013–0045,
by one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Please follow the
instructions for submitting comments.
• Email: dhs.pra@hq.dhs.gov Please
include docket number DHS- 2013–0045
in the subject line of the message.
SUPPLEMENTARY INFORMATION: Title II,
Homeland Security Act, 6 U.S.C.
121(d)(1) To access, receive, and
analyze law enforcement information,
intelligence information and other
information from agencies of the Federal
Government, State and local
government agencies . . . and Private
sector entities and to integrate such
information in support of the mission
responsibilities of the Department. The
following authorities also permit DHS to
collect information of the type
contemplated: Federal Information
Security Management Act of 2002
(FISMA), 44 U.S.C. 3546; Homeland
Security Presidential Directive (HSPD)
7, ‘‘Critical Infrastructure Identification,
Prioritization, and Protection’’ (2003);
and NSPD–54/HSPD–23, ‘‘Cybersecurity
Policy’’ (2008). In May 2009, the
President ordered a Cyberspace Policy
Review to develop a comprehensive
approach to secure and defend
America’s infrastructure. The review
built upon the Comprehensive National
Cybersecurity Initiative (CNCI).
In response to increased cyber threats
across the Nation, the National Initiative
for Cybersecurity Education (NICE)
expanded from a previous effort, the
CNCI Initiative #8. NICE formed in
2010, and is a nationally coordinated
effort comprised of over 20 federal
departments and agencies, and
numerous partners in academia and
industry. NICE focuses on cybersecurity
awareness, education, training and
professional development. NICE seeks
to encourage and build cybersecurity
awareness and competency across the
Nation and to develop an agile, highly
skilled cybersecurity workforce.
The National Initiative for
Cybersecurity Careers & Studies (NICCS)
Portal is a national online resource for
cybersecurity awareness, education,
talent management, and professional
development and training. NICCS Portal
is an implementation tool for NICE. Its
mission is to provide comprehensive
cybersecurity resources to the public.
Any information received from the
public in support of the NICCS Portal is
completely voluntary. Organizations
DATES:
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Pages 75822-75824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29721]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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: https://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, Sayyedeh.Mariani@fda.hhs.gov.
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 https://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 https://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 https://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 PatientFocused@fda.hhs.gov 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 https://www.regulations.gov.
Transcripts: As soon as a transcript is available, FDA will post it
at https://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
