Antibody Mediated Rejection in Kidney Transplantation; Public Workshop; Request for Comments, 16597-16598 [2017-06700]
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Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
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VerDate Sep<11>2014
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Jkt 241001
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Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2017–06670 Filed 4–4–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0726]
Antibody Mediated Rejection in Kidney
Transplantation; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
regarding new developments and
scientific issues related to antibody
mediated rejection (AMR) in kidney
transplantation. This public workshop
is intended to provide information for
and gain perspective from individuals,
industry, health care professionals,
researchers, public health organizations,
patients, patient care providers, and
other interested persons on various
aspects of clinical development of
medical products for prophylaxis and/or
treatment of AMR in kidney transplant
recipients, including clinical trial
design and endpoints. The input from
this public workshop will also help in
developing topics for future discussion.
DATES: The public workshop will be
held on April 12, 2017, from 8 a.m. to
6 p.m. and April 13, 2017, from 8:30
a.m. to 1:30 p.m. Submit either
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
16597
electronic or written comments on this
public workshop by April 27, 2017.
Late, untimely filed comments will not
be considered. Electronic comments
must be submitted on or before April 27,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 27, 2017. 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. See the SUPPLEMENTARY
INFORMATION section for registration date
and information. Workshop updates and
the workshop agenda will be made
available at: https://www.fda.gov/Drugs/
NewsEvents/ucm532070 prior to the
workshop.
The public workshop will
be held at the Tommy Douglas
Conference Center, 10000 New
Hampshire Ave., Silver Spring, MD
20903. The conference center’s phone
number is 240–645–4000.
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
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
E:\FR\FM\05APN1.SGM
05APN1
jstallworth on DSK7TPTVN1PROD with NOTICES
16598
Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
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–
2017–N–0726 for ‘‘Antibody Mediated
Rejection in Kidney Transplantation.’’
Received comments, those filed in a
timely manner (see DATES) 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.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 Division of Dockets
VerDate Sep<11>2014
15:11 Apr 04, 2017
Jkt 241001
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
Benner and/or Jessica Barnes, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6221,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop regarding AMR in kidney
transplantation. This public workshop
will focus on scientific considerations
in the clinical development of medical
products for prophylaxis and/or
treatment of AMR in kidney transplant
recipients.
Among the primary goals of this
workshop are the discussion of the role
of immunosuppressive medication
nonadherence in the development of de
novo donor specific antibody (DSA)
formation and subsequent AMR, new
developments in transplantation and
their impact on patient management
(such as pretransplant sensitization not
manifested by DSA, donor/recipient
human leukocyte antigen (HLA) epitope
matching, routine posttransplant DSA
monitoring), the natural course of the
acute-chronic AMR continuum and its
temporal association with cellular
rejection and changes in glomerular
filtration rate (GFR), unmet medical
needs and the potential implications of
these factors on the design of clinical
trials for the prevention and
management of AMR.
The Agency encourages individuals,
industry, health care professionals,
researchers, public health organizations,
patients, patient care providers, and
other interested persons to attend this
public workshop.
II. Participating in the Public Workshop
Registration: Persons interested in
attending this public workshop must
register by April 6, 2017, midnight
Eastern Time. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone to
AntibodyMediatedRejectionWorkshop
2017@fda.hhs.gov.
Registration is free and based on
space availability, with priority given to
early registrants. 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
PO 00000
Frm 00029
Fmt 4703
Sfmt 9990
public workshop will be provided
beginning at 7:30 a.m. on April 12,
2017, and 8 a.m. on April 13, 2017. 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 Jessica
Barnes or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) no later than
April 5, 2017.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session or participate
in a specific session, and which topic(s)
you wish to address. We will do our
best to accommodate requests to make
public comments and requests to
participate in the focused sessions.
Individuals and 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. All requests to
make oral presentations must be
received by the close of registration on
April 6, 2017. 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
April 7, 2017. If selected for
presentation, any presentation materials
must be emailed to AntibodyMediated
RejectionWorkshop2017@fda.hhs.gov no
later than April 10, 2017. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
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 Division of Dockets Management
(see ADDRESSES). A link to the transcript
will also be available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm532070.htm approximately 45 days
after the workshop.
Dated: March 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–06700 Filed 4–4–17; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\05APN1.SGM
05APN1
Agencies
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16597-16598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06700]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0726]
Antibody Mediated Rejection in Kidney Transplantation; 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 a public workshop regarding new developments and scientific
issues related to antibody mediated rejection (AMR) in kidney
transplantation. This public workshop is intended to provide
information for and gain perspective from individuals, industry, health
care professionals, researchers, public health organizations, patients,
patient care providers, and other interested persons on various aspects
of clinical development of medical products for prophylaxis and/or
treatment of AMR in kidney transplant recipients, including clinical
trial design and endpoints. The input from this public workshop will
also help in developing topics for future discussion.
DATES: The public workshop will be held on April 12, 2017, from 8 a.m.
to 6 p.m. and April 13, 2017, from 8:30 a.m. to 1:30 p.m. Submit either
electronic or written comments on this public workshop by April 27,
2017. Late, untimely filed comments will not be considered. Electronic
comments must be submitted on or before April 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 27, 2017. 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. See the SUPPLEMENTARY
INFORMATION section for registration date and information. Workshop
updates and the workshop agenda will be made available at: https://www.fda.gov/Drugs/NewsEvents/ucm532070 prior to the workshop.
ADDRESSES: The public workshop will be held at the Tommy Douglas
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.
The conference center's phone number is 240-645-4000.
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 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
[[Page 16598]]
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-2017-N-0726 for ``Antibody Mediated Rejection in Kidney
Transplantation.'' Received comments, those filed in a timely manner
(see DATES) 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.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 Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002, 301-796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public workshop regarding AMR in kidney
transplantation. This public workshop will focus on scientific
considerations in the clinical development of medical products for
prophylaxis and/or treatment of AMR in kidney transplant recipients.
Among the primary goals of this workshop are the discussion of the
role of immunosuppressive medication nonadherence in the development of
de novo donor specific antibody (DSA) formation and subsequent AMR, new
developments in transplantation and their impact on patient management
(such as pretransplant sensitization not manifested by DSA, donor/
recipient human leukocyte antigen (HLA) epitope matching, routine
posttransplant DSA monitoring), the natural course of the acute-chronic
AMR continuum and its temporal association with cellular rejection and
changes in glomerular filtration rate (GFR), unmet medical needs and
the potential implications of these factors on the design of clinical
trials for the prevention and management of AMR.
The Agency encourages individuals, industry, health care
professionals, researchers, public health organizations, patients,
patient care providers, and other interested persons to attend this
public workshop.
II. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop
must register by April 6, 2017, midnight Eastern Time. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone to
AntibodyMediatedRejectionWorkshop2017@fda.hhs.gov.
Registration is free and based on space availability, with priority
given to early registrants. 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.
on April 12, 2017, and 8 a.m. on April 13, 2017. 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 Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) no later than April 5, 2017.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments and requests to participate in the focused sessions.
Individuals and 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. All requests to make oral
presentations must be received by the close of registration on April 6,
2017. 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
April 7, 2017. If selected for presentation, any presentation materials
must be emailed to AntibodyMediatedRejectionWorkshop2017@fda.hhs.gov no
later than April 10, 2017. No commercial or promotional material will
be permitted to be presented or distributed at the public workshop.
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 Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm532070.htm approximately 45 days after the workshop.
Dated: March 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06700 Filed 4-4-17; 8:45 am]
BILLING CODE 4164-01-P