[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]


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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.

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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

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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