[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24172-24174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1137]


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 an FDA guidance document 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 guidance identified in this 
notice addresses issues related to the COVID-19 PHE and has been issued 
in accordance with the process announced in the March 25, 2020, notice. 
The guidance has been implemented without prior comment, 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 April 22, 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 (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 this guidance 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.

[[Page 24173]]


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.

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 Nationwide as the Result of the 
2019 Novel Coronavirus'' (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 
guidance:

                        Table 1--Guidance 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...................  Emergency Use              Office of Communication,
                                                              Authorization for          Outreach and
                                                              Vaccines to Prevent        Development, 10903 New
                                                              COVID-19 (Updated March    Hampshire Ave., Bldg.
                                                              31, 2022).                 71, Rm. 3128, Silver
                                                                                         Spring, MD 20993-0002,
                                                                                         1-800-835-4709 or 240-
                                                                                         402-8010; email
                                                                                         [email protected].
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    Although this guidance has been implemented immediately without 
prior comment, FDA will consider all comments received and revise the 
guidance as appropriate (see Sec.  10.115(g)(3)).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA. 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. Paperwork Reduction Act of 1995

    While this CBER 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 Guidances and Collections
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                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                               COVID-19 guidance               guidance               No(s).
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Emergency Use Authorization for Vaccines  21 CFR 314.420............  ..........................
 to Prevent COVID-19 (Updated March 31,   21 CFR part 312...........  ..........................
 2022).                                   21 CFR parts 210, 211, and  0910-0001.................
                                           610.                       0910-0014.................
                                                                      0910-0139.................

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                                          21 CFR part 600...........  ..........................       0910-0308
                                          21 CFR part 601...........  0910-0338.................
                                                                      Emergency Use                    0910-0595
                                                                       Authorization of Medical
                                                                       Products and Related
                                                                       Authorities.
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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: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08564 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P