Document ID: FDA-2016-D-0971-0005
Agency: fda
Document Type: Notice
Title: Infectious Disease Next Generation Sequencing Based Diagnostic 
Devices: Microbial Identification and Detection of Antimicrobial 
Resistance and Virulence Markers; Draft Guidance for Industry and Food 
and Drug Administration Staff; Extension of Comment Period
Posted Date: 2016-08-11T04:00Z

[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Pages 53149-53150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0971]

Infectious Disease Next Generation Sequencing Based Diagnostic 
Devices: Microbial Identification and Detection of Antimicrobial 
Resistance and Virulence Markers; Draft Guidance for Industry and Food 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 we) is extending the 
comment period for the document entitled ``Infectious Disease Next 
Generation Sequencing Based Diagnostic Devices: Microbial 
Identification and Detection of Antimicrobial Resistance and Virulence 
Markers; Draft Guidance for Industry and Food and Drug Administration 
Staff,'' that appeared in the Federal Register of May 13, 2016. In the 
document, FDA requested comments on FDA's recommendations to assist 
industry in designing studies to establish the analytical and clinical 
performance characteristics of infectious disease next generation 
sequencing-based diagnostic devices for microbial identification and 
detection of antimicrobial resistance and virulence markers. The Agency 
is taking this action in response to a request for an extension to 
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published 
May 13, 2016 (81 FR 29869). Submit either electronic or written 
comments by September 12, 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-2016-D-0971 for ``Infectious Disease Next Generation Sequencing 
Based Diagnostic Devices: Microbial Identification and Detection of 
Antimicrobial Resistance and Virulence Markers; Draft Guidance for 
Industry and Food and Drug Administration Staff.'' 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.

FOR FURTHER INFORMATION CONTACT: Heike Sichtig, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4526, Silver Spring, MD 20993-0002, 
Heike.Sichtig@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of May 13, 2016 (81 FR 29869), FDA 
published a document with a 90-day comment period to request comments 
on the types of studies the FDA recommends to support a premarket 
application of Infectious Disease Next Generation (NGS) Sequencing 
Based Diagnostic

[[Page 53150]]

Devices (Infectious Disease NGS Dx devices). Specifically, FDA 
recommends Infectious Disease NGS Dx devices that employ targeted or 
agnostic (metagenomics) sequencing to identify the presence or absence 
of infectious disease organisms, and/or detect the presence of absence 
of antimicrobial resistance and virulence markers.
    The Agency received requests for a 30-day extension of the comment 
period for the document. Each request conveyed concern that the current 
90-day comment period does not allow sufficient time to develop a 
meaningful or thoughtful response to the document on ``Infectious 
Disease Next Generation Sequencing Based Diagnostic Devices: Microbial 
Identification and Detection of Antimicrobial Resistance and Virulence 
Markers; Draft Guidance for Industry and Food and Drug Administration 
Staff.''
    FDA has considered the request and is extending the comment period 
for the document on ``Infectious Disease Next Generation Sequencing 
Based Diagnostic Devices: Microbial Identification and Detection of 
Antimicrobial Resistance and Virulence Markers; Draft Guidance for 
Industry and Food and Drug Administration Staff'' for 30 days, until 
September 10, 2016. The Agency believes that a 30-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying regulation on these important issues.

    Dated: August 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-19109 Filed 8-10-16; 8:45 am]
 BILLING CODE 4164-01-P