82 FR 35532 - Cardiac Troponin Assays; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 145 (July 31, 2017)

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Cardiac Troponin Assays.'' The purpose of the workshop is to discuss the development of innovative troponin assays designed to aid in the diagnosis of myocardial infarction (MI) and additional clinical uses of these assays. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices. Public input and feedback gained through this workshop may aid in the development of science-based approaches to aid in the efficient development of innovative, safe and effective, troponin diagnostic assays, which may lead to better patient care.

[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)]
[Notices]
[Pages 35532-35534]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4179]


Cardiac Troponin Assays; 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 ``Cardiac Troponin 
Assays.'' The purpose of the workshop is to discuss the development of 
innovative troponin assays designed to aid in the diagnosis of 
myocardial infarction (MI) and additional clinical uses of these 
assays. The workshop is intended to enhance engagement with 
stakeholders to facilitate device development and to discuss scientific 
and regulatory challenges associated with the analytical and clinical 
validation methods for troponin assay devices. Public input and 
feedback gained through this workshop may aid in the development of 
science-based approaches to aid in the efficient development of 
innovative, safe and effective, troponin diagnostic assays, which may 
lead to better patient care.

DATES: The public workshop will be held on November 28, 2017, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public workshop by November 27, 2017. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), 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 http://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 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 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.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: Go to 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-2017-N-4179 for ``Cardiac Troponin Assays.'' 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

[[Page 35533]]

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.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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula Caposino, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796-
6160, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Since first discovered, cardiac troponin has become increasingly 
valuable as a biomarker of MI. In 2007, the National Academy of 
Clinical Biochemistry Laboratory Medicine Practice Guidelines and the 
Joint European Society of Cardiology, American College of Cardiology 
Foundation, American Heart Association, and the World Heart Federation 
Task Force Guidelines recommended the use of cardiac troponin as a 
biomarker for the diagnosis of MI when used in conjunction with 
clinical evidence of myocardial ischemia (Refs. 1 and 2). Cardiac 
troponin has also been recommended in current clinical guidelines as a 
prognostic marker in patients with symptoms of acute coronary syndrome 
with respect to mortality, MI, or ischemic events. These 
recommendations solidified troponin's importance in MI diagnosis and 
triage; at the same time, they formalized an adjustment in the clinical 
cutoffs and changed the way troponin results were interpreted and used. 
There is a lot of interest in developing innovative troponin assays 
that aid in the diagnosis of MI and to support additional clinical uses 
of these assays. We are holding this public workshop to discuss several 
topics of interest that are important for the development of innovative 
cardiac troponin assays. The goal of the workshop is to enhance 
engagement with stakeholders concerning the development and validation 
of innovative troponin assay devices.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of brief presentations providing 
information to frame the discussion, followed by interactive panel 
discussions. Following the presentations, a moderated discussion is 
planned to ask speakers and additional panelists to provide their 
individual perspectives. Topics for discussion include:

 Clinical study design considerations and challenges
 Subgroup differences for troponin's clinical use (e.g., the 
need for sex-specific cutoffs)
 Reference range study design considerations and best practices 
for reference range study design and methods for calculating upper 
reference limits
 The use of deltas in the diagnosis of MI
 Point of care testing

    In light of the changes to how troponin is used clinically, there 
is a need to explore and discuss troponin assay device development and 
evaluation. We are soliciting comments and feedback from stakeholders 
regarding additional topics for FDA to consider for discussion. These 
comments can be submitted to the docket prior to the meeting (see 
ADDRESSES). We anticipate that the comments and discussion at this 
public workshop will help facilitate the development of innovative 
troponin devices and lessen regulatory burden. The ultimate goal is to 
facilitate the availability of innovative, safe and effective troponin 
assay devices for patient care.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
FDA's Medical Devices News & Events--Workshops & Conferences calendar 
at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by November 17, 2017, by 4 p.m. Eastern Time. 
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 Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
[email protected], no later than November 14, 2017.
    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 organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation. 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 November 20, 2017. 
All requests to make oral presentations must be received by the close 
of registration on

[[Page 35534]]

November 17, 2017 by 4 p.m. If selected for presentation, any 
presentation materials must be emailed to Paula Caposino (see FOR 
FURTHER INFORMATION CONTACT) no later than November 21, 2017. 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. The Webcast link will be available on the registration 
Web page after November 21, 2017. Organizations are requested to 
register all participants, but to view using one connection per 
location.
    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 http://www.adobe.com/go/connectpro_overview. FDA has verified the 
Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites 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 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

IV. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov.

1. ``National Academy of Clinical Biochemistry Laboratory Medicine 
Practice Guidelines: Clinical Characteristics and Utilization of 
Biochemical Markers in Acute Coronary Syndromes.'' Circulation, 
2007; 115, 356-375.
2. ``Universal Definition of Myocardial Infarction.'' Circulation, 
2007: 116, 2634-2653.


    Dated: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16007 Filed 7-28-17; 8:45 am]
 BILLING CODE 4164-01-P