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, 29461-29463 [2020-10492]
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Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
FD&C Act. The regulations provide
instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d). Objections and
requests must be submitted within the
time specified in § 12.20(e). Each
objection, for which a hearing has been
requested, must be separately numbered
and specify the provision of the
regulation or the proposed order. In
addition, each objection must include a
detailed description and analysis of the
factual information and any other
document, with some exceptions,
supporting the objection. Failure to
include this information constitutes a
waiver of the right to a hearing on that
objection. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under 21 CFR 12.24 and does
not limit the evidence that may be
presented if a hearing is granted. We
estimate five respondents will file a
request under the regulation and assume
each request requires 20 hours to
prepare, for a total of 100 hours
annually.
Finally, § 12.45 (21 CFR 12.45), issued
under section 701 of the FD&C Act, sets
forth content, format, and procedural
requirements for any interested person
to file a petition to participate in a
formal evidentiary hearing, either
personally or through a representative.
Section 12.45 requires that any person
filing a notice of participation state their
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including the specific issues of fact
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notice include a statement that the
person will present testimony at the
hearing and will comply with specific
requirements in 21 CFR 12.85, or, in the
case of a hearing before a Public Board
of Inquiry, concerning disclosure of data
and information by participants (21 CFR
13.25). In accordance with § 12.45(e),
the presiding officer may omit a
participant’s appearance. Based on our
records, we estimate five filings under
this regulation and assume it requires 3
hours to prepare, for a total of 15 hours
annually.
Respondents to the information
collection are those interested persons
conducting business with FDA, and
thus subject to the applicable
administrative regulations.
The burden estimates for this
collection of information are based on
Agency records and our experience over
the past 3 years. By revising the
information collection to include
additional provisions, we have
increased our annual burden estimate
by 869 responses and 1,096 hours.
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10384 Filed 5–14–20; 8:45 am]
BILLING CODE 4164–01–P
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.
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 SARSCoV–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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
29461
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
E:\FR\FM\15MYN1.SGM
15MYN1
jbell on DSKJLSW7X2PROD with NOTICES
29462
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
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-201509-18/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 § 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
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed 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.
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
1 https://www.fda.gov/media/135010/download;.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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 § 10.115(g)(2)).
Although this guidance is immediately
in effect, FDA will consider all
comments received and revise the
guidance document as appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and at
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.
E:\FR\FM\15MYN1.SGM
15MYN1
Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Notices
https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders. 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
COVID–19
guidance title
Policy for Coronavirus Disease-2019 Tests During the
Public Health Emergency.
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
CFR cite
referenced in
COVID–19
guidance
Another guidance
referenced in
COVID–19 guidance
..........................
Emergency Use Authorization of Medical Products
and Related Authorities;
Guidance for Industry and
Other Stakeholders.
Administrative Procedures for
Clinical Laboratory Improvement Amendments of
1988 Categorization.
De Novo Classification Process (Evaluation of Automatic Class III Designation).
803
807, subparts A
through D.
807, subpart E
820 ..................
29463
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/publichealth-emergency-declaration-prawaivers.
OMB Control
No(s).
New collection covered by PHE
PRA waiver
0910–0595
0910–0607
0910–0844
0910–0437
0910–0625
0910–0120
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.
Dated: May 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
jbell on DSKJLSW7X2PROD with NOTICES
[FR Doc. 2020–10492 Filed 5–14–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:09 May 14, 2020
Jkt 250001
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15MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/media/135010/download;.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
