Public Meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant, 24818-24820 [2016-09785]
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24818
Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
estimates for the implementation and
cost study and the impact study
components of the current request. The
requested extension period is estimated
to be two years and three months, from
July 1, 2016 to September 30, 2018.
Thus, burden hours for all components
are annualized over two years and three
months.
IMPLEMENTATION AND COST STUDY
Total
number of
respondents
Instrument
Staff interview topic guide ....................................................
Study MIS to track program participation ............................
Number of
responses per
respondent
120
200
Average
burden hours
per response
Total
burden hours
Total annual
burden hours a
1
468.75
1
0.0333
120
3,125
53
1,390
9
1
1
9
1
1
0.1667
0.1667
0.5833
0.1667
8
0.75
180
175
583
180
256
1,107
80
78
259
80
114
492
Impact Study
Introductory script:
Grantee staff .................................................................
Program applicants b .....................................................
Baseline survey ....................................................................
Study MIS to conduct random assignment .........................
Protocol for collecting administrative records ......................
12 month follow-up survey ...................................................
120
1,050
1,000
120
32
1,476
a All
burden estimates are annualized over 2.25 years.
percent of program applicants are not expected to agree to participate in the study; thus there are 5% more program applicants than
study participants.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
b Five
Estimated Total Annual Burden
Hours: 2,546.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–09803 Filed 4–26–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–N–2016–1134]
Public Meeting on Patient-Focused
Drug Development for Patients Who
Have Received an Organ Transplant
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
patients who have received an organ
transplant. 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 receiving
an organ transplant on daily life and
patient views on treatment approaches;
the input from this public meeting will
help in developing topics for further
discussion. FDA is also interested in
discussing issues related to scientific
challenges in developing drugs to
manage organ transplantation. In the
afternoon, FDA will hold a workshop
and provide information for and gain
perspective from patients and patient
advocacy organizations, health care
providers, academic experts, and
industry on various aspects of clinical
SUMMARY:
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development of drug products intended
to manage organ transplantation.
DATES: The public meeting will be held
on September 27, 2016, from 9 a.m. to
5 p.m. Please register here for the
meeting by September 20, 2016: https://
organtransplantpfdd.eventbrite.com.
Submit electronic or written comments
to the public docket by November 27,
2016.
The meeting and workshop
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 https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\27APN1.SGM
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Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions):Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–1134 for ‘‘Public Meeting on
Patient-Focused Drug Development for
Patients Who Have Received an Organ
Transplant.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
VerDate Sep<11>2014
17:29 Apr 26, 2016
Jkt 238001
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm495933.htm.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993, 301–796–
5003, FAX: 301–847–8443,
graham.thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected patients who have
received an organ transplant 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 these conditions.
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
Safety and Innovation Act (Pub. L. 112–
144). The full set of performance
commitments is available at https://
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’
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24819
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 July 2, 2015, FDA published a
notice (80 FR 32816) in the Federal
Register announcing the disease areas
for meetings in fiscal years 2016–2017,
final 2 years of PDUFA V time frame.
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. In
selecting the set of disease areas, FDA
carefully considered the public
comments received and the perspectives
of review divisions at FDA. 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 and Workshop
Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused
Drug Development meeting is to obtain
input on organ transplantation and
current approaches to management of
organ transplantation. In 2015, over
25,000 people in the United States
received an organ transplant. Organ
transplantation requires pharmacologic
and non-pharmacologic management
before and after receipt. There are FDAapproved therapies used to assist the
immune system in responding properly
to the transplanted organ. Treatment
requires a combination of drugs given
for the lifetime of a transplanted organ.
FDA is committed to working with all
stakeholders to develop safe and
effective therapies for affected
individuals.
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). When
submitting comments, if you are
commenting on behalf of a child, please
indicate that you are doing so and
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Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
answer the following questions as much
as possible from the patient’s
perspective.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. What have been the most
significant changes in your overall
health since you received your
transplanted organ?
(a) How long has it been since you
received your transplant?
2. Focusing on symptoms related to
your organ transplant and posttransplant effects, which 1–3 symptoms
have the most significant impact on
your life? (Examples may include pain,
infection, anxiety, etc.)
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 your transplant? (Examples
of activities may include sleeping
through the night, driving, walking/
running, exercising, etc.)
(a) How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
(Examples may include limitations on
the ability to undertake physically
strenuous activities, restrictions on the
ability to travel, lack of appetite, fatigue,
etc.)
4. How has your experience with your
transplanted organ changed over time?
Do particular symptoms come and go as
your duration of time with a
transplanted organ has increased? If so,
do you know of anything that makes
your symptoms better? Worse?
5. What worries you most about your
health post-transplant?
Topic 2: Patients’ Perspectives on
Transplant and Treatment Impacts
1. What are you currently doing to
maintain your transplanted organ or
treat related health concerns following
transplantation? (Examples may include
immunosuppressants, antibiotics,
antivirals, over-the-counter products,
and other therapies including non-drug
therapies)
(a) How has your post-transplant
treatment regimen changed over time,
and why?
2. How well does your current
treatment regimen manage the most
significant symptoms you experience
post-transplantation?
(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 experiences
post-transplant have changed over time?
3. What are the most significant
downsides to your current treatments,
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Jkt 238001
and how do they affect your daily life?
(Examples of downsides may include
bothersome side effects, need for
multiple medications, risk of infection,
need for hospitalization, etc.)
(a) What are the biggest challenges
you face in maintaining your posttransplant treatment regimen?
(Examples of challenges may be
bothersome side effects, need for
multiple medications, etc.)
4. What specific things would you
look for in an ideal treatment for
managing your transplanted organ?
In the afternoon, discussion will be
related to scientific topics, with the goal
of understanding issues that may affect
the development of drugs for the
treatment of organ transplantation and
identifying topics for future discussion.
Discussion topics for the afternoon will
include the following: Current treatment
considerations, adherence, clinical trial
designs, and clinical trial endpoints.
FDA will hold an open public
comment period to give the public an
opportunity to comment. Registration
for open public comment will occur at
the registration desk on the day of the
meeting and workshop on a first-come,
first-served basis.
Docket Comments: Regardless of if
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 November 27, 2016.
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/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm495933.htm.
B. Meeting Attendance and
Participation
If you wish to attend this meeting,
visit https://
organtransplantpfdd.eventbrite.com.
Please register by September 20, 2016. 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 firstcome, 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 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 also must send to
PatientFocused@fda.hhs.gov a brief
summary of responses to the topic
questions by September 12, 2016.
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.
Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
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[FR Doc. 2016–09785 Filed 4–26–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0514]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Requests for
Clinical Laboratory Improvement
Amendments Categorization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
requests for Clinical Laboratory
Improvement Amendments of 1998
(CLIA) categorization of in vitro
diagnostic tests when a premarket
review is not needed.
DATES: Submit either electronic or
written comments on the collection of
information by June 27, 2016.
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Pages 24818-24820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09785]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-N-2016-1134]
Public Meeting on Patient-Focused Drug Development for Patients
Who Have Received an Organ Transplant
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 patients who have received an organ
transplant. 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
receiving an organ transplant on daily life and patient views on
treatment approaches; the input from this public meeting will help in
developing topics for further discussion. FDA is also interested in
discussing issues related to scientific challenges in developing drugs
to manage organ transplantation. In the afternoon, FDA will hold a
workshop and provide information for and gain perspective from patients
and patient advocacy organizations, health care providers, academic
experts, and industry on various aspects of clinical development of
drug products intended to manage organ transplantation.
DATES: The public meeting will be held on September 27, 2016, from 9
a.m. to 5 p.m. Please register here for the meeting by September 20,
2016: https://organtransplantpfdd.eventbrite.com. Submit electronic or
written comments to the public docket by November 27, 2016.
ADDRESSES: The meeting and workshop 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or
[[Page 24819]]
anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions):Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-1134 for ``Public Meeting on Patient-Focused Drug
Development for Patients Who Have Received an Organ Transplant.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm495933.htm.
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, graham.thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected patients who have received an organ transplant 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 these conditions. 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 Safety
and Innovation Act (Pub. L. 112-144). The full set of performance
commitments is available at https://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 July 2, 2015, FDA published a notice (80 FR 32816) in the
Federal Register announcing the disease areas for meetings in fiscal
years 2016-2017, final 2 years of PDUFA V time frame. 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. In selecting the
set of disease areas, FDA carefully considered the public comments
received and the perspectives of review divisions at FDA. 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 and Workshop Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused Drug Development meeting is to
obtain input on organ transplantation and current approaches to
management of organ transplantation. In 2015, over 25,000 people in the
United States received an organ transplant. Organ transplantation
requires pharmacologic and non-pharmacologic management before and
after receipt. There are FDA-approved therapies used to assist the
immune system in responding properly to the transplanted organ.
Treatment requires a combination of drugs given for the lifetime of a
transplanted organ. FDA is committed to working with all stakeholders
to develop safe and effective therapies for affected individuals.
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). When submitting comments, if you are
commenting on behalf of a child, please indicate that you are doing so
and
[[Page 24820]]
answer the following questions as much as possible from the patient's
perspective.
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
1. What have been the most significant changes in your overall
health since you received your transplanted organ?
(a) How long has it been since you received your transplant?
2. Focusing on symptoms related to your organ transplant and post-
transplant effects, which 1-3 symptoms have the most significant impact
on your life? (Examples may include pain, infection, anxiety, etc.)
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 your
transplant? (Examples of activities may include sleeping through the
night, driving, walking/running, exercising, etc.)
(a) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days? (Examples may include
limitations on the ability to undertake physically strenuous
activities, restrictions on the ability to travel, lack of appetite,
fatigue, etc.)
4. How has your experience with your transplanted organ changed
over time? Do particular symptoms come and go as your duration of time
with a transplanted organ has increased? If so, do you know of anything
that makes your symptoms better? Worse?
5. What worries you most about your health post-transplant?
Topic 2: Patients' Perspectives on Transplant and Treatment Impacts
1. What are you currently doing to maintain your transplanted organ
or treat related health concerns following transplantation? (Examples
may include immunosuppressants, antibiotics, antivirals, over-the-
counter products, and other therapies including non-drug therapies)
(a) How has your post-transplant treatment regimen changed over
time, and why?
2. How well does your current treatment regimen manage the most
significant symptoms you experience post-transplantation?
(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
experiences post-transplant have 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, need for multiple
medications, risk of infection, need for hospitalization, etc.)
(a) What are the biggest challenges you face in maintaining your
post-transplant treatment regimen? (Examples of challenges may be
bothersome side effects, need for multiple medications, etc.)
4. What specific things would you look for in an ideal treatment
for managing your transplanted organ?
In the afternoon, discussion will be related to scientific topics,
with the goal of understanding issues that may affect the development
of drugs for the treatment of organ transplantation and identifying
topics for future discussion. Discussion topics for the afternoon will
include the following: Current treatment considerations, adherence,
clinical trial designs, and clinical trial endpoints.
B. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://organtransplantpfdd.eventbrite.com. Please register by September 20,
2016. 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 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 also
must send to PatientFocused@fda.hhs.gov a brief summary of responses to
the topic questions by September 12, 2016. 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.
FDA will hold an open public comment period to give the public an
opportunity to comment. Registration for open public comment will occur
at the registration desk on the day of the meeting and workshop on a
first-come, first-served basis.
Docket Comments: Regardless of if 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
November 27, 2016. 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/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm495933.htm.
Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09785 Filed 4-26-16; 8:45 am]
BILLING CODE 4164-01-P
