Document ID: FDA-2016-D-0971-0001
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Resistance and Virulence Markers; Draft Guidance for Industry and Food 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; Availability
Posted Date: 2016-05-13T04:00Z

[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29869-29870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11237]

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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Resistance and Virulence Markers; Draft Guidance for Industry and Food 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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Infectious Disease Next 
Generation Sequencing Based Diagnostic Devices: Microbial 
Identification and Detection of Antimicrobial Resistance and Virulence 
Markers.'' This draft guidance provides recommendations to assist 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. This draft 
guidance is neither final nor is it in effect at this time.

DATES: 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 11, 2016.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; Availability.'' 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.
    Submit written requests for single copies of the guidance 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 requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

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, 301-796-4574.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides 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 (hereinafter referred 
to as ``Infectious Disease NGS Dx devices''). Infectious Disease NGS Dx 
devices are intended for use as an aid in the diagnosis of microbial 
infection and in selecting appropriate therapies for

[[Page 29870]]

which next generation sequencing (NGS) technology can now be used to 
detect the presence of clinically important pathogenic organisms in 
human specimens.
    In contrast to human sequencing diagnostics, infectious disease 
sequencing diagnostics carry an absolute need for immediate and 
actionable results, sometimes within hours, as incorrect initial 
diagnoses potentially leads to fatalities. Furthermore, the broad range 
of specimen types (e.g., urine, blood, cerebrospinal fluid (CSF), 
stool, sputum, etc.) and the large diversity of the infectious disease 
agents that can be present in the sample do not allow straightforward 
pre-analytical-, biochemical-, or bioinformatics processes. Each unique 
specimen type may require a different nucleic acid extraction 
procedure, a different library preparation protocol, and even a 
different bioinformatics algorithm to generate the final clinical 
result. The opportunity for repeat testing is expected to be limited 
due to a frequently small specimen quantity (e.g., CSF) and the 
necessity to make a prompt and timely infectious disease treatment 
decision for the patient.
    This draft guidance, when finalized, provides detailed information 
on the types of studies the FDA recommends to support a premarket 
application for these devices. This draft guidance specifically 
addresses Infectious Disease NGS devices that employ targeted or 
agnostic (metagenomic) sequencing, to identify the presence or absence 
of infectious disease organisms, and/or to detect the presence or 
absence of antimicrobial resistance and virulence markers. This draft 
guidance is not intended to address devices that utilize detection 
mechanisms other than nucleic acid based approaches. Further, this 
draft guidance does not apply to devices that are intended to screen 
donors of blood and blood components as well as donors of human cells, 
tissues, and cellular and tissue-based products for communicable 
diseases.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on ``Infectious 
Disease Next Generation Sequencing Based Diagnostic Devices: Microbial 
Identification and Detection of Antimicrobial Resistance and Virulence 
Markers.'' It neither creates nor confers any rights for or on any 
person and is not binding on FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

III. 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 ``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; Availability'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1500016 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR parts 801 and 809 have been 
approved under OMB control number 0910-0485; the collections of 
information in 21 CFR part 807, subpart E, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
812 have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

    Dated: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11237 Filed 5-12-16; 8:45 am]
 BILLING CODE 4164-01-P