[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 [email protected] 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]
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