82 FR 16597 - Antibody Mediated Rejection in Kidney Transplantation; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 64 (April 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 64 (April 5, 2017)
| Page Range | 16597-16598 | |
| FR Document | 2017-06700 |
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)] [Notices] [Pages 16597-16598] From the Federal Register Online [www.thefederalregister.org] [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: 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.thefederalregister.org/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 [email protected]. 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 [email protected] 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
![Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices 16597
those strategies. The interview will finalists, and winners of the Contest. electronic or written comments on this
focus on systems and processes and Information is not collected for public workshop by April 27, 2017.
should not require preparation time by commercial marketing. Champions are Late, untimely filed comments will not
the Champion. The estimated time for permitted to cite that they were selected be considered. Electronic comments
the interview is two hours, which as Champions for the 2017 Million must be submitted on or before April 27,
includes time to review the interview Hearts Hypertension Control Challenge. 2017. The https://www.regulations.gov
protocol with the interviewer, respond General Conditions: electronic filing system will accept
to the interview questions, and review HHS/CDC reserves the right to cancel, comments until midnight Eastern Time
a summary data about the Champion’s suspend, and/or modify the Challenge, at the end of April 27, 2017. Comments
practices. The summary will be written or any part of it, for any reason, at HHS/ received by mail/hand delivery/courier
as a success story and will be posted on CDC’s sole discretion. If the Challenge is (for written/paper submissions) will be
the Million Hearts® Web site. cancelled, suspended, and/or modified, considered timely if they are
Additional Information: HHS/CDC will inform the public postmarked or the delivery service
Information received from nominees through the publication of a notice in acceptance receipt is on or before that
will be stored in a password protected the Federal Register. date. See the SUPPLEMENTARY
file on a secure server. The challenge Participation in this Contest INFORMATION section for registration date
Web site may post the number of constitutes a contestants’ full and and information. Workshop updates and
nominations received but will not unconditional agreement to abide by the the workshop agenda will be made
include confidential or proprietary Contest’s Official Rules found at available at: http://www.fda.gov/Drugs/
information about individual nominees, www.Challenge.gov. NewsEvents/ucm532070 prior to the
as described further below. The workshop.
Authority: 15 U.S.C. 3719.
database of information submitted by
nominees will not be posted on the Web Dated: March 30, 2017. ADDRESSES: The public workshop will
site. Information collected from Sandra Cashman, be held at the Tommy Douglas
nominees will include general details, Executive Secretary, Centers for Disease Conference Center, 10000 New
such as the business name, address, and Control and Prevention. Hampshire Ave., Silver Spring, MD
contact information of the nominee. [FR Doc. 2017–06670 Filed 4–4–17; 8:45 am] 20903. The conference center’s phone
This type of information is generally BILLING CODE 4163–18–P
number is 240–645–4000.
publicly available. The nomination will You may submit comments as
collect and store only aggregate clinical follows:
data through the nomination process; no DEPARTMENT OF HEALTH AND Electronic Submissions
individual identifiable patient data will HUMAN SERVICES
be collected or stored. Confidential or Submit electronic comments in the
propriety data, clearly marked as such, Food and Drug Administration following way:
will be secured to the full extent • Federal eRulemaking Portal:
[Docket No. FDA–2017–N–0726]
allowable by law. https://www.regulations.gov. Follow the
Information for selected Champions, Antibody Mediated Rejection in Kidney instructions for submitting comments.
such as the provider, practice, or health Transplantation; Public Workshop; Comments submitted electronically,
system’s name, location, hypertension Request for Comments including attachments, to https://
control rate, and clinic practices that www.regulations.gov will be posted to
support hypertension control will be AGENCY: Food and Drug Administration, the docket unchanged. Because your
shared through press releases, the HHS. comment will be made public, you are
challenge Web site, and Million Hearts® ACTION: Notice of public workshop; solely responsible for ensuring that your
and HHS/CDC resources. request for comments. comment does not include any
Summary data on the types of systems confidential information that you or a
SUMMARY: The Food and Drug third party may not wish to be posted,
and processes that all nominees use to
Administration (FDA, the Agency, or such as medical information, your or
control hypertension may be shared in
we) is announcing a public workshop anyone else’s Social Security number, or
documents or other communication
regarding new developments and confidential business information, such
products that describe generally used
scientific issues related to antibody as a manufacturing process. Please note
practices for successful hypertension
mediated rejection (AMR) in kidney that if you include your name, contact
control. HHS/CDC will use the summary
transplantation. This public workshop information, or other information that
data only as described.
Compliance with Rules and is intended to provide information for identifies you in the body of your
Contacting Contest Winners: and gain perspective from individuals, comments, that information will be
Finalists and the Champions must industry, health care professionals, posted on https://www.regulations.gov.
comply with all terms and conditions of researchers, public health organizations, • If you want to submit a comment
these Official Rules, and winning is patients, patient care providers, and with confidential information that you
contingent upon fulfilling all other interested persons on various do not wish to be made available to the
requirements herein. The initial finalists aspects of clinical development of public, submit the comment as a
will be notified by email, telephone, or medical products for prophylaxis and/or written/paper submission and in the
mail after the date of the judging. treatment of AMR in kidney transplant manner detailed (see ‘‘Written/Paper
recipients, including clinical trial
jstallworth on DSK7TPTVN1PROD with NOTICES
Privacy: Submissions’’ and ‘‘Instructions’’).
If Contestants choose to provide HHS/ design and endpoints. The input from
CDC with personal information by this public workshop will also help in Written/Paper Submissions
registering or filling out the submission developing topics for future discussion. Submit written/paper submissions as
form through the Challenge.gov Web DATES: The public workshop will be follows:
site, that information is used to respond held on April 12, 2017, from 8 a.m. to • Mail/Hand delivery/Courier (for
to Contestants in matters regarding their 6 p.m. and April 13, 2017, from 8:30 written/paper submissions): Division of
submission, announcements of entrants, a.m. to 1:30 p.m. Submit either Dockets Management (HFA–305), Food
VerDate Sep<11>2014 15:11 Apr 04, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\05APN1.SGM 05APN1](https://thefederalregister.org/doc/82_FR_16661/page/1.svg)
![16598 Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, rm. public workshop will be provided
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. beginning at 7:30 a.m. on April 12,
• For written/paper comments FOR FURTHER INFORMATION CONTACT: Lori 2017, and 8 a.m. on April 13, 2017. We
submitted to the Division of Dockets Benner and/or Jessica Barnes, Center for will let registrants know if registration
Management, FDA will post your Drug Evaluation and Research, Food closes before the day of the public
comment, as well as any attachments, and Drug Administration, 10903 New workshop.
except for information submitted, Hampshire Ave., Bldg. 22, Rm. 6221,
marked and identified, as confidential, If you need special accommodations
Silver Spring, MD 20993–0002, 301– due to a disability, please contact Jessica
if submitted as detailed in 796–1300.
‘‘Instructions.’’ Barnes or Lori Benner (see FOR FURTHER
Instructions: All submissions received SUPPLEMENTARY INFORMATION: INFORMATION CONTACT) no later than
must include the Docket No. FDA– I. Background April 5, 2017.
2017–N–0726 for ‘‘Antibody Mediated Requests for Oral Presentations:
Rejection in Kidney Transplantation.’’ FDA is announcing a public
workshop regarding AMR in kidney During online registration you may
Received comments, those filed in a indicate if you wish to present during a
timely manner (see DATES) will be transplantation. This public workshop
will focus on scientific considerations public comment session or participate
placed in the docket and, except for
in the clinical development of medical in a specific session, and which topic(s)
those submitted as ‘‘Confidential
products for prophylaxis and/or you wish to address. We will do our
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the treatment of AMR in kidney transplant best to accommodate requests to make
Division of Dockets Management recipients. public comments and requests to
between 9 a.m. and 4 p.m., Monday Among the primary goals of this participate in the focused sessions.
through Friday. workshop are the discussion of the role Individuals and organizations with
• Confidential Submissions—To of immunosuppressive medication common interests are urged to
submit a comment with confidential nonadherence in the development of de consolidate or coordinate their
information that you do not wish to be novo donor specific antibody (DSA) presentations, and request time for a
made publicly available, submit your formation and subsequent AMR, new joint presentation, or submit requests for
comments only as a written/paper developments in transplantation and designated representatives to participate
submission. You should submit two their impact on patient management in the focused sessions. All requests to
copies total. One copy will include the (such as pretransplant sensitization not make oral presentations must be
information you claim to be confidential manifested by DSA, donor/recipient received by the close of registration on
with a heading or cover note that states human leukocyte antigen (HLA) epitope April 6, 2017. Following the close of
‘‘THIS DOCUMENT CONTAINS matching, routine posttransplant DSA
registration, we will determine the
CONFIDENTIAL INFORMATION.’’ The monitoring), the natural course of the
amount of time allotted to each
Agency will review this copy, including acute-chronic AMR continuum and its
temporal association with cellular presenter and the approximate time
the claimed confidential information, in each oral presentation is to begin, and
its consideration of comments. The rejection and changes in glomerular
filtration rate (GFR), unmet medical will select and notify participants by
second copy, which will have the
claimed confidential information needs and the potential implications of April 7, 2017. If selected for
redacted/blacked out, will be available these factors on the design of clinical presentation, any presentation materials
for public viewing and posted on trials for the prevention and must be emailed to AntibodyMediated
https://www.regulations.gov. Submit management of AMR. RejectionWorkshop2017@fda.hhs.gov no
both copies to the Division of Dockets The Agency encourages individuals, later than April 10, 2017. No
Management. If you do not wish your industry, health care professionals, commercial or promotional material
name and contact information to be researchers, public health organizations, will be permitted to be presented or
made publicly available, you can patients, patient care providers, and distributed at the public workshop.
provide this information on the cover other interested persons to attend this Transcripts: Please be advised that as
sheet and not in the body of your public workshop. soon as a transcript of the public
comments and you must identify this workshop is available, it will be
II. Participating in the Public Workshop
information as ‘‘confidential.’’ Any accessible at https://
information marked as ‘‘confidential’’ Registration: Persons interested in
www.regulations.gov. It may be viewed
will not be disclosed except in attending this public workshop must
register by April 6, 2017, midnight at the Division of Dockets Management
accordance with 21 CFR 10.20 and other
Eastern Time. Please provide complete (see ADDRESSES). A link to the transcript
applicable disclosure law. For more
information about FDA’s posting of contact information for each attendee, will also be available on the Internet at
comments to public dockets, see 80 FR including name, title, affiliation, http://www.fda.gov/Drugs/NewsEvents/
56469, September 18, 2015, or access address, email, and telephone to ucm532070.htm approximately 45 days
the information at: https://www.gpo.gov/ AntibodyMediatedRejectionWorkshop after the workshop.
fdsys/pkg/FR-2015-09-18/pdf/2015- 2017@fda.hhs.gov. Dated: March 29, 2017.
23389.pdf. Registration is free and based on Anna K. Abram,
Docket: For access to the docket to space availability, with priority given to
Deputy Commissioner for Policy, Planning,
read background documents or the early registrants. Early registration is
jstallworth on DSK7TPTVN1PROD with NOTICES
Legislation, and Analysis.
electronic and written/paper comments recommended because seating is
[FR Doc. 2017–06700 Filed 4–4–17; 8:45 am]
received, go to https:// limited; therefore, FDA may limit the
www.regulations.gov and insert the number of participants from each BILLING CODE 4164–01–P
docket number, found in brackets in the organization. Registrants will receive
heading of this document, into the confirmation when they have been
‘‘Search’’ box and follow the prompts accepted. If time and space permit,
and/or go to the Division of Dockets onsite registration on the day of the
VerDate Sep<11>2014 15:11 Apr 04, 2017 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 9990 E:\FR\FM\05APN1.SGM 05APN1](https://thefederalregister.org/doc/82_FR_16661/page/2.svg)
Document Created: 2018-02-01 14:47:11
Document Modified: 2018-02-01 14:47:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 16597 |
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