[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 106-109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1825 and FDA-2020-D-1138]


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 4, 2021.

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: 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.

[[Page 107]]

    <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 (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.
    <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 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 guidances.

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, Alex 
M. Azar II, 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) (PHS Act), determined that a PHE exists and has existed 
since January 27, 2020, nationwide.\1\ On March 13, 2020, President 
Donald J. Trump declared 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 Alex M. Azar, II, 
``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://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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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 (FD&C 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:

[[Page 108]]



   Table 1--Guidances Related to the COVID-19 Public Health Emergency
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                                                             Contact
                                            Title of      information to
       Docket No.            Center         guidance      request single
                                                              copies
------------------------------------------------------------------------
FDA-2020-D-1825.........  CBER........  Investigational  Office of
                                         COVID-19         Communication,
                                         Convalescent     Outreach and
                                         Plasma           Development,
                                         (Updated         10903 New
                                         November 2020).  Hampshire
                                                          Ave., Bldg.
                                                          71, Rm. 3128,
                                                          Silver Spring,
                                                          MD 20993-0002;
                                                          1-800-835-4709
                                                          or 240-402-
                                                          8010; email
                                                          <a href="/cdn-cgi/l/email-protection#d7b8b4b8b397b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="caa5a9a5ae8aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a>.
FDA-2020-D-1138.........  CDRH........  Notifying CDRH   CDRH-
                                         of a Permanent   <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="db9caeb2bfbab5b8be9bbdbfbaf5b3">[email protected]</a>
                                         Discontinuance   hs.gov. Please
                                         or               include the
                                         Interruption     document
                                         in               number 20032-
                                         Manufacturing    R2 and
                                         of a Device      complete title
                                         Under Section    of the
                                         506J of the      guidance in
                                         FD&C Act         the request.
                                         During the
                                         COVID-19
                                         Public Health
                                         Emergency
                                         (Revised)
                                         (November
                                         2020).
FDA-2020-D-1138.........  CDRH........  Enforcement      CDRH-
                                         Policy for       <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="0b4c7e626f6a65686e4b6d6f6a2563">[email protected]</a>
                                         Bioburden        hs.gov. Please
                                         Reduction        include the
                                         Systems Using    document
                                         Dry Heat to      number 20044
                                         Support Single-  and complete
                                         User Reuse of    title of the
                                         Certain          guidance in
                                         Filtering        the request.
                                         Facepiece
                                         Respirators
                                         During the
                                         Coronavirus
                                         Disease 2019
                                         (COVID-19)
                                         Public Health
                                         Emergency
                                         (November
                                         2020).
FDA-2020-D-1138.........  CDRH........  Enforcement      CDRH-
                                         Policy for the   <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="f9be8c909d98979a9cb99f9d98d791">[email protected]</a>
                                         Quality          hs.gov. Please
                                         Standards of     include the
                                         the              document
                                         Mammography      number 20047
                                         Quality          and complete
                                         Standards Act    title of the
                                         During the       guidance in
                                         COVID-19         the request.
                                         Public Health
                                         Emergency
                                         (December
                                         2020).
------------------------------------------------------------------------

    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 
guidances have been approved by OMB as listed in the following table:

                                     Table 2--CBER Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                        CFR cite referenced in        Another guidance title        OMB control
      COVID-19 guidance title             COVID-19 guidance           referenced in COVID-19          No(s).
-----------------------------------------------------------------------------guidance---------------------------
Investigational COVID-19             21 CFR part 312............  ..............................       0910-0014
 Convalescent Plasma (Updated        21 CFR parts 610, 606, and   ..............................       0910-0116
 November 2020).                      630.
                                                                  Form FDA 3926.................       0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidances

    While these guidances contain no collection of information, they do 
refer to previously approved FDA collections of information (listed in 
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for these guidances. These previously approved 
collections of information are subject to review by OMB under the PRA. 
The collections of information in the following FDA statutory 
provision, regulations and guidances have been approved by OMB as 
listed in the following table. These guidances also contain a 
collection of information that has been granted a PHE waiver from the 
PRA by 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
----------------------------------------------------------------------------------------------------------------
                                                          Another guidance                      New collection
     COVID-19 guidance title       Citation referenced  referenced in COVID-   OMB control    covered by PHE PRA
                                       in COVID-19          19 guidance          No(s).             waiver
-----------------------------------------guidance---------------------------------------------------------------
Notifying CDRH of a Permanent      Section 506J (21     ...................       0910-0491
 Discontinuance or Interruption     U.S.C.356j) of the
 in Manufacturing of a Device       FD&C Act.
 Under Section 506J of the FD&C
 Act During the COVID-19 Public
 Health Emergency (Revised)
 (November 2020).
                                   21 CFR Part 807,     ...................       0910-0625
                                    subparts A through
                                    D.

[[Page 109]]

 
                                                        Emergency Use             0910-0595
                                                         Authorization of
                                                         Medical Products
                                                         and Related
                                                         Authorities;
                                                         Guidance for
                                                         Industry and Other
                                                         Stakeholders.
                                                                                             Updates to FDA
                                                                                              every 6 weeks
                                                                                              after initial
                                                                                              notification on
                                                                                              the shortage
                                                                                              situation.
                                                                                             Voluntary
                                                                                              submission of
                                                                                              other information.
Enforcement Policy for Bioburden   ...................  Emergency Use             0910-0595
 Reduction Systems Using Dry Heat                        Authorization of
 to Support Single-User Reuse of                         Medical Products
 Certain Filtering Facepiece                             and Related
 Respirators During the                                  Authorities;
 Coronavirus Disease 2019 (COVID-                        Guidance for
 19) Public Health Emergency                             Industry and Other
 (November 2020).                                        Stakeholders.
                                                                                             Labeling of the
                                                                                              bioburden
                                                                                              reduction system.
Enforcement Policy for the         21 CFR Part 900....  ...................       0910-0309
 Quality Standards of the
 Mammography Quality Standards
 Act [MQSA] During the COVID-19
 Public Health Emergency
 (December 2020).
                                                                                             Document the time
                                                                                              period that the
                                                                                              facility was
                                                                                              temporarily closed
                                                                                              and present
                                                                                              information during
                                                                                              the facility's
                                                                                              MQSA inspection.
                                                                                             Document and
                                                                                              provide the
                                                                                              circumstances re:
                                                                                              lack of medical
                                                                                              physicist survey
                                                                                              within 14 months
                                                                                              of the last annual
                                                                                              survey.
                                                                                             Information on
                                                                                              inability to meet
                                                                                              the survey
                                                                                              timeframes
                                                                                              described in the
                                                                                              guidance.
                                                                                             Provide
                                                                                              documentation of
                                                                                              the dates and
                                                                                              events that led to
                                                                                              noncompliance and
                                                                                              that facility will
                                                                                              ensure compliance
                                                                                              as soon as
                                                                                              possible after
                                                                                              COVID-19
                                                                                              restrictions are
                                                                                              lifted.
----------------------------------------------------------------------------------------------------------------

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

    Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29058 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P


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