Document ID: FDA-2020-D-0987-0049
Agency: fda
Document Type: Notice
Title: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability
Posted Date: 2020-05-15T04:00Z

[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29461-29463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0987]

Policy for Coronavirus Disease-2019 Tests During the Public 
Health Emergency; Immediately in Effect Guidance for Clinical 
Laboratories, Commercial Manufacturers, 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 Coronavirus 
Disease-2019 Tests 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 SARS-CoV-2 testing. This 
guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020. 
The guidance describes four policies intended to help facilitate the 
development and use of SARS-CoV-2 tests during the public health 
emergency: Two policies for accelerating the development of certain 
laboratory tests for COVID-19--one leading to an Emergency Use 
Authorization (EUA) submission to FDA and the other not leading to an 
EUA submission when the test is developed under the authorities of the 
State in which the laboratory resides and the State takes 
responsibility for COVID-19 testing by laboratories in its State; a 
policy for commercial manufacturers to more rapidly distribute their 
SARS-CoV-2 diagnostics to laboratories for specimen testing after 
validation while an EUA submission is being prepared for submission to 
FDA; and a policy regarding the use of serological testing. In 
addition, FDA has included a reference to the availability, on FDA's 
website, of templates for commercial manufacturers and laboratories 
intended to facilitate EUA submissions for molecular, antigen, and 
serology tests. 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 May 15, 2020.

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 Coronavirus Disease-2019 Tests During 
the Public Health Emergency.'' Received comments will be placed in the 
docket

[[Page 29462]]

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 Coronavirus Disease-2019 Tests 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 Schuck, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3556, Silver Spring, MD 20993-0002, 301-
796-5199.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance entitled ``Policy 
for Coronavirus Disease-2019 Tests During the Public Health 
Emergency.'' 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 SARS-CoV-2 testing. This guidance was originally 
published on February 29, 2020, to describe 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. The guidance was subsequently updated on 
March 16, 2020, to include a policy enabling States to take 
responsibility for oversight of laboratory developed tests within their 
States, a policy for commercial manufacturers to more rapidly 
distribute their SARS-CoV-2 diagnostic tests to laboratories for 
specimen testing after validation while an EUA is being prepared for 
submission to FDA, and a policy regarding the use of serological 
testing without an EUA. The guidance was then updated on May 4, 2020, 
to revise the policy regarding SARS-CoV-2 serology tests as it pertains 
to commercial manufacturers. Among other things, the updated guidance 
explained that commercial manufacturers should submit an EUA for their 
distributed serology tests within 10 business days of notification to 
FDA of validation or publication of the guidance published on May 4, 
2020, whichever is later. The current version of the guidance was 
posted on May 11, 2020.
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    \1\ https://www.fda.gov/media/135010/download;.
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    This guidance does not change the policies in the May 4, 2020, 
guidance but includes a new section that references the availability, 
on FDA's website, of templates for commercial manufacturers and 
laboratories intended to facilitate EUA submissions for molecular, 
antigen, and serology tests. The templates provide information and 
recommendations, and FDA plans to update them as appropriate as we 
learn more about the COVID-19 disease and gain experience with the EUA 
process for the various types of COVID-19 tests.
    In the context of a public health emergency involving pandemic 
infectious disease, it is critically important that tests are validated 
because false results can have a broad public health impact beyond that 
to the individual patient. In this guidance, FDA provides 
recommendations regarding validation of COVID-19 tests, which remain 
unchanged from the guidance published on May 4, 2020. FDA encourages 
test developers to discuss any alternative approaches to validation 
with FDA.
    In light of this public health emergency,\2\ 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.
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    \2\ Secretary of Health and Human Services Alex M. Azar, 
Determination that a Public Health Emergency Exists. (January 31, 
2020, renewed April 21, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
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    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 Coronavirus Disease-2019 Tests 
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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and at

[[Page 29463]]

https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders. Persons unable to download an electronic copy of ``Policy 
for Coronavirus Disease-2019 Tests During the Public Health Emergency; 
Immediately in Effect Guidance for Clinical Laboratories, Commercial 
Manufacturers, 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-R3 and 
complete title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved 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 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following FDA regulations and guidances have been approved by 
OMB as listed in the below table. This guidance also contains a new 
collection of information not approved under a current collection. This 
new collection of information has been granted a public health 
emergency (PHE) waiver from the PRA by the Department of HHS on March 
19, 2020, under section 319(f) of the Public Health Services Act. 
Information concerning the PHE PRA waiver can be found on the HHS 
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

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                                         CFR cite         Another guidance                      New collection
     COVID-19  guidance title         referenced in        referenced in       OMB Control   covered by PHE  PRA
                                    COVID-19 guidance    COVID-19 guidance       No(s).             waiver
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Policy for Coronavirus Disease-    ...................  Emergency Use             0910-0595  ...................
 2019 Tests During the Public                            Authorization of
 Health Emergency.                                       Medical Products
                                                         and Related
                                                         Authorities;
                                                         Guidance for
                                                         Industry and Other
                                                         Stakeholders.
                                                        Administrative            0910-0607
                                                         Procedures for
                                                         Clinical
                                                         Laboratory
                                                         Improvement
                                                         Amendments of 1988
                                                         Categorization.
                                                        De Novo                   0910-0844
                                                         Classification
                                                         Process
                                                         (Evaluation of
                                                         Automatic Class
                                                         III Designation).
                                   803                                            0910-0437
                                   807, subparts A                                0910-0625
                                    through D.
                                   807, subpart E.....                            0910-0120
                                   820................                            0910-0073
                                                                                             Laboratory
                                                                                              voluntary
                                                                                              reporting to FDA
                                                                                              of testing
                                                                                              capacity
                                                                                              information.
                                                                                             Manufacturer
                                                                                              voluntary
                                                                                              reporting to FDA
                                                                                              of testing
                                                                                              capacity
                                                                                              information and
                                                                                              the number of
                                                                                              laboratories in
                                                                                              the U.S. with the
                                                                                              required platforms
                                                                                              installed.
                                                                                             Laboratory
                                                                                              voluntary
                                                                                              reporting to FDA
                                                                                              of validation
                                                                                              data, when
                                                                                              validating through
                                                                                              a bridging study
                                                                                              and not pursuing
                                                                                              an EUA for the
                                                                                              modification.
                                                                                             State or territory
                                                                                              voluntary
                                                                                              notification to
                                                                                              FDA of decision to
                                                                                              authorize
                                                                                              laboratories
                                                                                              within that State
                                                                                              or territory to
                                                                                              develop and
                                                                                              perform a test for
                                                                                              COVID-19 under
                                                                                              authority of its
                                                                                              own State law.
                                                                                             Laboratory
                                                                                              voluntary
                                                                                              notification to
                                                                                              FDA that they have
                                                                                              started clinical
                                                                                              testing and
                                                                                              voluntary
                                                                                              reporting of
                                                                                              testing capacity
                                                                                              information, when
                                                                                              the laboratory is
                                                                                              authorized to
                                                                                              develop and
                                                                                              perform a test for
                                                                                              COVID-19 under
                                                                                              authority of a
                                                                                              State or
                                                                                              territory.
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    Dated: May 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10492 Filed 5-14-20; 8:45 am]
BILLING CODE 4164-01-P