Document ID: FDA-2017-N-4179-0004
Agency: fda
Document Type: Notice
Title: Cardiac Troponin Assays; Public Workshop; Request for Comments; 
Extension of Comment Period
Posted Date: 2017-11-17T05:00Z

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54348-54349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24922]

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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; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period provided in the notice entitled ``Cardiac Troponin 
Assays; Public Workshop; Request for Comments'' that appeared in the 
Federal Register on July 31, 2017. That notice announced the public 
workshop and requested comments by November 28, 2017; FDA is extending 
the public

[[Page 54349]]

workshop's comment period by 30 days to December 28, 2017, in response 
to requests for an extension to allow interested persons additional 
time to submit comments.

DATES: FDA is extending the comment period for the public workshop 
``Cardiac Troponin Assays'' published on July 31, 2017 (82 FR 35532). 
Submit either electronic or written comments by December 28, 2017.

ADDRESSES: 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 December 28, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 28, 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: 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; Public Workshop; Request 
for Comments.'' 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: 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: In the Federal Register of July 31, 2017 (82 
FR 35532), FDA published a notice announcing the public workshop 
entitled ``Cardiac Troponin Assays; Public Workshop; Request for 
Comments'' with a 120-day comment period to request comments.
    The Agency has received requests for a 30-day extension of the 
comment period for the public workshop. The request conveyed concern 
that the current 120-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the public workshop.
    FDA has considered the request and is extending the comment period 
for the public workshop for 30 days, until December 28, 2017. The 
Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments.

    Dated: November 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-24922 Filed 11-16-17; 8:45 am]
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