[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Resistance and Virulence Markers; Draft Guidance for Industry and Food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availability of a draft guidance entitled ``Infectious Disease Next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 This draft guidance provides recommendations to assist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 This draft
guidance is neither final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 11, 2016.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 [email protected] 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]
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