[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13169-13170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04630]
[[Page 13169]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-0987]
Policy for Diagnostics Testing in Laboratories Certified To
Perform High Complexity Testing Under the Clinical Laboratory
Improvement Amendments Prior to Emergency Use Authorization for
Coronavirus Disease-2019 During the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories and Food and
Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Policy for Diagnostics
Testing in Laboratories Certified to Perform High Complexity Testing
under CLIA prior to Emergency Use Authorization for Coronavirus
Disease-2019 during the Public Health Emergency.'' On February 4, 2020,
the Secretary of Health and Human Services (HHS) determined that there
is a public health emergency and that circumstances exist justifying
the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid
detection of Coronavirus Disease-2019 (COVID-19) cases in the United
States requires wide availability of diagnostic testing to control the
emergence of this rapidly spreading, severe illness. This guidance
describes a policy regarding laboratories using tests they develop and
validate before FDA has issued an Emergency Use Authorization (EUA) for
their test in order to achieve more rapid testing capacity in the
United States. The guidance document is immediately in effect, but it
remains subject to comment in accordance with the Agency's good
guidance practices.
DATES: The announcement of the guidance is published in the Federal
Register on March 6, 2020. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2020-D-0987 for ``Policy for Diagnostics Testing in Laboratories
Certified to Perform High Complexity Testing under CLIA prior to
Emergency Use Authorization for Coronavirus Disease-2019 during the
Public Health Emergency.'' Received comments 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.govinfo.gov/content/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.
You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) 21 CFR 10.115(g)(5)).
An electronic copy of the 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 guidance document entitled
``Policy for Diagnostics Testing in Laboratories Certified to Perform
High Complexity Testing under CLIA prior to Emergency Use Authorization
for Coronavirus Disease-2019 during the Public Health Emergency'' to
the Office of Policy, 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: Brittany Goldberg, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire
[[Page 13170]]
Ave., Bldg. 66, Rm. 3108, Silver Spring, MD 20993-0002, 301-796-2977.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``Policy
for Diagnostics Testing in Laboratories Certified to Perform High
Complexity Testing under CLIA prior to Emergency Use Authorization for
Coronavirus Disease-2019 during the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories and Food and
Drug Administration Staff.'' On February 4, 2020, the Secretary of HHS
determined that there is a public health emergency and that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection and/or diagnosis of the novel
coronavirus (2019-nCoV).\1\ Rapid detection of COVID-19 cases in the
United States requires wide availability of diagnostic testing to
control the emergence of this rapidly spreading, severe illness. This
guidance describes a policy regarding laboratories using tests they
develop and validate before FDA has issued an EUA for their test in
order to achieve more rapid testing capacity in the United States.
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\1\ https://www.fda.gov/media/135010/download.
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In light of this public health emergency, FDA has determined that
prior public participation for this guidance is not feasible or
appropriate and is issuing this guidance without prior public comment
(see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec. 10.115(g)(2)). Although this
guidance is immediately in effect, FDA will consider all comments
received and revise the guidance document as appropriate.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on ``Policy for Diagnostics Testing in
Laboratories Certified to Perform High Complexity Testing under CLIA
prior to Emergency Use Authorization for Coronavirus Disease-2019
during the Public Health Emergency.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Policy for
Diagnostics Testing in Laboratories Certified to Perform High
Complexity Testing under CLIA prior to Emergency Use Authorization for
Coronavirus Disease-2019 during the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories and Food and
Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 20010 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved FDA collections of
information. 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. 3501-3521). The collection of information for
``Emergency Use Authorization of Medical Products and Related
Authorities Guidance for Industry and Other Stakeholders'' has been
approved under OMB control number 0910-0595.
Dated: March 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04630 Filed 3-5-20; 8:45 am]
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