Document ID: FDA-2017-N-0726-0001
Agency: fda
Document Type: Notice
Title: Antibody Mediated Rejection in Kidney Transplantation; Public 
Workshop; Request for Comments
Posted Date: 2017-04-05T04:00Z

[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]

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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.

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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: http://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 http://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