[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3303-3306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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 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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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, 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: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning 
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), 
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. 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 
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
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    In the Federal Register of March 25, 2020 (85 FR 16949) (the March 
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), 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 https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) 
and ``Search for FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    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
                                                                                        [email protected].

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FDA-2020-D-1138...................  CDRH..................  Enforcement Policy for     CDRH-
                                                             Viral Transport Media      [email protected].
                                                             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         [email protected].
                                                             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 https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     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.
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                                                        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:
     FDA web page entitled ``COVID-19-Related Guidance 
Documents for Industry, FDA Staff, and Other Stakeholders,'' available 
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance 
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

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