
[Federal Register Volume 81, Number 17 (Wednesday, January 27, 2016)]
[Notices]
[Pages 4632-4633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01610]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4803]


Public Notification of Emerging Postmarket Medical Device Signals 
('Emerging Signals'); Draft Guidance for Industry and Food and Drug 
Administration Staff; 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the comment period for the draft guidance for Industry and Food and 
Drug Administration Staff entitled ``Public Notification of Emerging 
Postmarket Medical Device Signals ('Emerging Signals').'' A notice of 
the availability of the draft guidance and our request for comments 
appeared in the Federal Register of December 31, 2015. We initially 
established February 29, 2016, as the deadline for the submission of 
requested comments that can help improve the Agency's policy for 
notifying the public about medical device ``emerging signals.'' The 
Agency is taking this action due to the unanticipated high-level of 
interest from external stakeholders and the medical device community 
and will allow interested persons additional time to submit comments.

DATES:  FDA is extending the comment period on the ``Public 
Notification of Emerging Postmarket Medical Device Signals ('Emerging 
Signals')''; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability, which was announced in the Notice 
published December 31, 2015 (80 FR 81829). Although you can comment on 
any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the 
Agency considers your comment of this draft guidance before it begins 
work on the final version of the guidance, submit either electronic or 
written comments on the draft guidance by March 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 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-2015-D-4803 for ``Public Notification of Emerging Postmarket 
Medical Device Signals ('Emerging Signals').'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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.
    An electronic copy of the draft guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Public Notification of Emerging Postmarket Medical Device Signals 
('Emerging Signals')'' to the Office of the Center Director, Guidance 
and Policy Development, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 31, 2015, FDA published a 
notice announcing the availability of a draft guidance entitled 
``Public Notification of Emerging Postmarket Medical Device Signals 
('Emerging Signals'),'' with a 60-day comment period to request 
comments on the Agency's policy for

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notifying the public about medical device ``emerging signals.''
    FDA is extending the comment period for the publication 
notification of ``emerging signals'' for 30 days, until March 29, 2016. 
The Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Public Notification of 
Emerging Postmarket Medical Device Signals ('Emerging Signals')'' may 
send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. Please use the document number 1500027 
to identify the guidance you are requesting.

    Dated: January 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01610 Filed 1-26-16; 8:45 am]
 BILLING CODE 4164-01-P


