Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for Comments, 46170-46172 [2018-19816]
Download as PDF
<![CDATA[
46170
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
suggestion and will implement the
revision.
We also received comment that some
users have experienced ‘‘timing out’’
while completing Form FDA 3500B
online and requested that any time limit
for completing online forms be
extended. We were not aware of this
issue and will investigate to see whether
it relates to the online functionality of
the form. If so, we will make the
necessary adjustments.
While we are especially appreciative
of the comments received in response to
our notice, we continue to welcome
feedback at all times regarding ways we
might improve the MedWatch Program
and the associated forms. In addition to
the revisions discussed previously, on
our own initiative we are now including
burden associated with written
submissions under § 329.100(c)(2) (21
CFR 329.100(c)(2)) that request a
temporary waiver from the electronic
reporting requirements associated with
postmarket adverse drug events under
section 760 of the FD&C Act. While we
expect few such waiver requests, we
retain a placeholder for one respondent
annually, and we estimate it takes 1
hour to complete the request.
We therefore estimate the burden for
the information collection as follows.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA center or 21 CFR section and/or FDA form
Number of
respondents
Center for Biologics Evaluation and Research/Center
for Drug Evaluation and Research:
Form 3500 ............................................................
Form 3500A (§§ 310.305, 314.80, 314.98,
600.80, and 1271.350).
Form 3500A (§ 310.305 outsourcing facilities) .....
Center for Devices and Radiological Health:
Form 3500 ............................................................
Form 3500A (part 803) .........................................
Center for Food Safety and Applied Nutrition:
Form 3500 ............................................................
Form 3500A ..........................................................
Center for Tobacco Products:
Form 3500 ............................................................
All Centers:
Form 3500B ..........................................................
Written requests for temporary waiver under
§ 329.100(c)(2):
Total ......................................................................
1 There
Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19742 Filed 9–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3010]
daltland on DSKBBV9HB2PROD with NOTICES
Average
burden per
response
Total annual
responses
Total hours
14,727
599
1
98
14,727
58,702
0.66 (40 minutes) ..
1.21 ........................
9,720
71,029
50
2
100
1.21 ........................
121
5,233
2,277
1
296
5,233
673,992
0.66 (40 minutes) ...
1.21 ........................
3,454
815,530
1,793
1,659
1
1
1,793
1,659
0.66 (40 minutes) ...
1.21 ........................
1,183
2,007
39
1
39
0.66 (40 minutes) ...
26
13,750
1
1
1
13, 750
1
0.46 (28 minutes) ..
1 .............................
6,325
1
........................
........................
........................
................................
909,396
are no capital costs or operating and maintenance costs associated with this collection of information.
While we retain the currently
approved estimate for the information
collection, as noted previously we have
added burden associated with written
submissions under § 329.100.
Evidence-Based Treatment Decision in
Transplantation: Patient Individualized
Treatment; Choosing the Right
Regimen for the Right Patient; Public
Workshop; Request for Comments
AGENCY:
Number of
responses per
respondent
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
VerDate Sep<11>2014
18:41 Sep 11, 2018
Jkt 244001
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Evidence-Based
Treatment Decision in Transplantation:
Patient Individualized Treatment;
Choosing the Right Regimen for the
Right Patient.’’ This public workshop is
intended to discuss potential candidate
biomarkers to determine organ
transplant patients’ immunologic risk
for organ rejection or tolerance. The
public workshop will include
discussion of the biomarker
qualification process and how it could
be used to develop biomarkers for use
in clinical trials in transplantation, to
develop new drugs to address unmet
needs, and in clinical practice to guide
patient treatment selection. Speakers
will be patients who will provide
perspective on the challenges of living
with a transplant, managing
immunosuppression and perspectives
on tolerability, adherence, and risk that
may inform patient-reported outcome
(PRO) and patient-focused drug
development.
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
The public workshop will be
held on September 27, 2018, from 8:30
a.m. to 6 p.m. and September 28, 2018,
from 8 a.m. to 12:30 p.m. Submit either
electronic or written comments on this
public workshop by November 19, 2018.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503, sections B and C), Silver Spring,
MD 20993. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 19, 2018. The
DATES:
E:\FR\FM\12SEN1.SGM
12SEN1
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 19, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
daltland on DSKBBV9HB2PROD with NOTICES
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
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–N–3010 for ‘‘Evidence-Based
Treatment Decision in Transplantation:
Patient Individualized Treatment;
Choosing the Right Regimen for the
Right Patient.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
VerDate Sep<11>2014
18:41 Sep 11, 2018
Jkt 244001
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Derek Alberding or Ramou Pratt, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–0963, derek.alberding@
fda.hhs.gov, or 301–796–3928,
ramou.pratt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop entitled ‘‘Evidence-Based
Treatment Decision in Transplantation:
Patient Individualized Treatment;
Choosing the Right Regimen for the
Right Patient.’’ This public workshop is
intended for academic experts, industry,
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
46171
healthcare providers, patients, other
U.S. Government Agencies, and other
stakeholders.
II. Topics for Discussion at the Public
Workshop
Presentations and discussions will
cover identifying potential candidate
biomarkers that could:
• Be considered for the biomarker
qualification process
• be used in identifying patients at
high immunologic risk or low
immunologic risk
• be used in clinical trials to develop
drugs to address unmet individual
needs in transplantation
• be used to make appropriate
immunosuppressive regimen treatment
decisions
In addition, patient speakers will
provide perspectives on:
• Challenges of living with a
transplant,
• managing immunosuppression, and
• tolerability, adherence, and risk of
therapy.
The goal of these presentations is to
inform PRO and patient-focused drug
development.
III. Participating in the Public
Workshop
Registration: Registration is free and
based on space availability, with
priority given to early registrants.
Persons interested in attending this
public workshop must register by
September 14, 2018, midnight Eastern
Time. To register, please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone to
TransplantationWorkshop2018@
fda.hhs.gov.
Early registration is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization.
Registrants will receive confirmation
when they have been accepted. If time
and space permit, onsite registration on
the day of the public workshop will be
provided beginning at 7:30 a.m. We will
let registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Derek
Alberding or Ramou Pratt (see FOR
FURTHER INFORMATION CONTACT) no later
than September 13, 2018.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session and which
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. Individuals and
E:\FR\FM\12SEN1.SGM
12SEN1
46172
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. Following the
close of registration, we will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
September 14, 2018. All requests to
make oral presentations must be
received by September 10, 2018. If
selected for presentation, any
presentation materials must be emailed
to TransplantationWorkshop2018@
fda.hhs.gov (see FOR FURTHER
INFORMATION CONTACT) no later than
September 19, 2018. No commercial or
promotional material will be permitted
to be presented or distributed at the
public workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast at https://
collaboration.fda.gov/ebtd092018/.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm605761.htm.
Dated: September 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19816 Filed 9–11–18; 8:45 am]
BILLING CODE 4164–01–P
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on
October 10, 2018, from 8 a.m. to 1 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–3308.
The docket will close on October 9,
2018. Submit either electronic or
written comments on this public
meeting by October 9, 2018. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before October
9, 2018. The https://www.regulations.
gov electronic filing system will accept
comments until midnight Eastern Time
at the end of October 9, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before
October 1, 2018, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments as
follows:
DATES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2018–N–3308]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:41 Sep 11, 2018
Jkt 244001
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–N–3308 for ‘‘Oncologic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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.’’ FDA
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 Dockets Management Staff.
E:\FR\FM\12SEN1.SGM
12SEN1
]]>Agencies
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46170-46172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3010]
Evidence-Based Treatment Decision in Transplantation: Patient
Individualized Treatment; Choosing the Right Regimen for the Right
Patient; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Evidence-Based
Treatment Decision in Transplantation: Patient Individualized
Treatment; Choosing the Right Regimen for the Right Patient.'' This
public workshop is intended to discuss potential candidate biomarkers
to determine organ transplant patients' immunologic risk for organ
rejection or tolerance. The public workshop will include discussion of
the biomarker qualification process and how it could be used to develop
biomarkers for use in clinical trials in transplantation, to develop
new drugs to address unmet needs, and in clinical practice to guide
patient treatment selection. Speakers will be patients who will provide
perspective on the challenges of living with a transplant, managing
immunosuppression and perspectives on tolerability, adherence, and risk
that may inform patient-reported outcome (PRO) and patient-focused drug
development.
DATES: The public workshop will be held on September 27, 2018, from
8:30 a.m. to 6 p.m. and September 28, 2018, from 8 a.m. to 12:30 p.m.
Submit either electronic or written comments on this public workshop by
November 19, 2018. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance
for the public workshop participants (non-FDA employees) is through
Building 1 where routine security check procedures will be performed.
For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 19, 2018. The
[[Page 46171]]
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of November 19, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
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 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-3010 for ``Evidence-Based Treatment Decision in
Transplantation: Patient Individualized Treatment; Choosing the Right
Regimen for the Right Patient.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Derek Alberding or Ramou Pratt, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, 240-402-0963, [email protected], or 301-796-3928,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public workshop entitled ``Evidence-Based
Treatment Decision in Transplantation: Patient Individualized
Treatment; Choosing the Right Regimen for the Right Patient.'' This
public workshop is intended for academic experts, industry, healthcare
providers, patients, other U.S. Government Agencies, and other
stakeholders.
II. Topics for Discussion at the Public Workshop
Presentations and discussions will cover identifying potential
candidate biomarkers that could:
Be considered for the biomarker qualification process
be used in identifying patients at high immunologic risk
or low immunologic risk
be used in clinical trials to develop drugs to address
unmet individual needs in transplantation
be used to make appropriate immunosuppressive regimen
treatment decisions
In addition, patient speakers will provide perspectives on:
Challenges of living with a transplant,
managing immunosuppression, and
tolerability, adherence, and risk of therapy.
The goal of these presentations is to inform PRO and patient-
focused drug development.
III. Participating in the Public Workshop
Registration: Registration is free and based on space availability,
with priority given to early registrants. Persons interested in
attending this public workshop must register by September 14, 2018,
midnight Eastern Time. To register, please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone to
[email protected].
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 7:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact Derek Alberding or Ramou Pratt (see FOR FURTHER INFORMATION
CONTACT) no later than September 13, 2018.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and
[[Page 46172]]
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by September 14, 2018. All
requests to make oral presentations must be received by September 10,
2018. If selected for presentation, any presentation materials must be
emailed to [email protected] (see FOR FURTHER
INFORMATION CONTACT) no later than September 19, 2018. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at https://collaboration.fda.gov/ebtd092018/.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm605761.htm.
Dated: September 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19816 Filed 9-11-18; 8:45 am]
BILLING CODE 4164-01-P
