Guidance Documents Related to Coronavirus Disease 2019; Availability

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Published

January 21, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

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<title>Federal Register, Volume 87 Issue 14 (Friday, January 21, 2022)</title>
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[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3303-3306]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1137, FDA-2020-D-1138, FDA-2020-D-0987]

Guidance Documents Related to Coronavirus Disease 2019;
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 FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on January 21, 2022.

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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 name of the
guidance document that the comments address and the docket number for
the guidance

[[Page 3304]]

(see table 1). Received comments will be placed in the docket(s) and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, or Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
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\1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), available at: <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx</a>.
\2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: <a href="https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/">https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/</a>. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
<a href="https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic">https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic</a>.
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In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at <a href="https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf">https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf</a>), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec. 10.115(g)(2)). The guidances are available on
FDA's web pages entitled ``COVID-19-Related Guidance Documents for
Industry, FDA Staff, and Other Stakeholders'' (available at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>)
and ``Search for FDA Guidance Documents'' (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>).
The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

Table 1--Guidances Related to the COVID-19 Public Health Emergency
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Contact information to
Docket No. Center Title of guidance request single copies
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FDA-2020-D-1137................... CBER.................. Policy for Certain REMS Office of Communication,
Requirements During the Outreach and
Tocilizumab Shortage Development, 10903 New
Related to the COVID-19 Hampshire Ave., Bldg.
Public Health Emergency 71, Rm. 3128, Silver
(December 2021). Spring, MD 20993-0002, 1-
800-835-4709 or 240-402-
8010; email
<a href="/cdn-cgi/l/email-protection#f699959992b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="ef808c808baf898b8ec187879cc1888099">[email&#160;protected]</span></a>.

[[Page 3305]]

FDA-2020-D-1138................... CDRH.................. Enforcement Policy for CDRH-
Viral Transport Media <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="4601332f222728252306202227682e2e3568212930">[email&#160;protected]</a>.
During the Coronavirus Please include the
Disease (COVID-19) document number 20038-R2
Public Health Emergency and complete title of
(Revised November 2021). the guidance in the
request.
FDA-2020-D-0987................... CDRH.................. Policy for Coronavirus CDRH-
Disease-2019 Tests <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="e2a5978b86838c8187a2848683cc8a8a91cc858d94">[email&#160;protected]</a>.
During the Public Health Please include the
Emergency (Revised document number 20010-R4
November 2021). and complete title of
the guidance in the
request.
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Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec. 10.115(g)(3)).
These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are 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. Paperwork Reduction Act of 1995

A. CBER Guidance

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

Table 2--CBER Guidance and Collections
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CFR cite referenced in Another guidance title OMB control
COVID-19 guidance title COVID-19 guidance referenced in COVID-19 guidance No(s).
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Policy for Certain REMS Requirements 21 CFR part 314 (New ............................... 0910-0001
During the Tocilizumab Shortage Drug Applications and
Related to the COVID-19 Public Abbreviated New Drug
Health Emergency (December 2021). Applications).
21 CFR parts 210, 211 ............................... 0910-0139
and 610 (Current Good
Manufacturing
Practices).
21 CFR part 600 (Adverse ............................... 0910-0308
Experience Reports).
21 CFR part 601 ............................... 0910-0338
(Biologic License
Applications).
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B. CDRH Guidances

The guidances listed below refer to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in the following FDA regulations and guidances have been approved by
OMB as listed in the table below (table 3). These guidances also
contain a new collection of information not approved under a current
collection. These new collections of information have been granted a
public health emergency (PHE) waiver from the PRA by the Department of
Health and Human Services (HHS) on March 19, 2020, under section 319(f)
of the PHS Act. Information concerning the PHE PRA waiver can be found
on the HHS website at <a href="https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers">https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers</a>.

Table 3--CDRH Guidances and Collections
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Another guidance New Collection
COVID-19 guidance title CFR cite referenced referenced in COVID- OMB Control covered by PHE PRA
in COVID-19 19 guidance No(s). Waiver
-----------------------------------------guidance---------------------------------------------------------------
Enforcement Policy for Viral Emergency Use 0910-0595 ...................
Transport Media During the Authorization of
Coronavirus Disease 2019 (COVID- Medical Products
19) Public Health Emergency and Related
(Revised November 2021) Authorities;
(document number 20038-R2). Guidance for
Industry and Other
Stakeholders.
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Administrative 0910-0607 ...................
Procedures for
Clinical
Laboratory
Improvement
Amendments of 1988
Categorization.
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800, 801, and 809.. ................... 0910-0485 ...................
803................ ................... 0910-0437 ...................
806................ ................... 0910-0359 ...................

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807, subparts A ................... 0910-0625 ...................
through D.
807, subpart E..... ................... 0910-0120 ...................
820................ ................... 0910-0073 ...................
830 and 801.20..... ................... 0910-0720 ...................
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Manufacturer
voluntary
reporting to FDA
of viral transport
media
manufacturing
capacity
information.
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Manufacturer
voluntary
reporting to FDA
of sterile
phosphate buffered
saline/saline
manufacturing
capacity
information.
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Policy for Coronavirus Disease-
2019 Tests During the Public
Health Emergency (Revised
November 2021) (document number
20010-R4).
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Emergency Use 0910-0595 ...................
Authorization of
Medical Products
and Related
Authorities;
Guidance for
Industry and Other
Stakeholders.
----------------------------------------------------------------------------------------------------------------
Administrative 0910-0607 ...................
Procedures for
Clinical
Laboratory
Improvement
Amendments of 1988
Categorization.
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803................ Medical Device 0910-0437 ...................
Reporting.
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Confirmation to FDA
that the developer
of a diagnostic or
serology test on
FDA's notification
lists and for
which an Emergency
Use Authorization
(EUA) request was
submitted, wants
FDA to continue
reviewing its EUA
request.
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IV. Electronic Access

Persons with access to the internet may obtain COVID-19-related
guidances at:
<bullet> FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>;
<bullet> FDA web page entitled ``Search for FDA Guidance
Documents'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>; or
<bullet> <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01146 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P

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