Document ID: FDA-2020-D-0987-0008
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2020-03-06T05:00Z

[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 CDRH-Guidance@fda.hhs.gov 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]
BILLING CODE 4164-01-P