[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55620-55623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1138]


Guidance Documents Related to Coronavirus Disease 2019; 
Availability

AGENCY: Food and Drug Administration, Health and Human Services (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. FDA is also announcing the withdrawal of two FDA guidance 
documents related to the COVID-19 PHE.

DATES: The announcement of the guidances is published in the Federal 
Register on October 6, 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:
     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

[[Page 55621]]

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 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: Kimberly Thomas, Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; 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 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.

[[Page 55622]]

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-1136...........  CDER..................  Development of Abbreviated     druginfo@fda.hhs.gov. Please
                                                     New Drug Applications During   include the docket number
                                                     the COVID-19 Pandemic--        FDA-2020-D-1136 and complete
                                                     Questions and Answers;         title of the guidance in the
                                                     Guidance for Industry          request.
                                                     (Updated September 2021).
FDA-2020-D-1138...........  CDRH..................  Enforcement Policy for Face    CDRH-Guidance@fda.hhs.gov.
                                                     Masks, Barrier Face            Please include the document
                                                     Coverings, Face Shields,       number 20018 and complete
                                                     Surgical Masks, and            title of the guidance in the
                                                     Respirators During the         request.
                                                     Coronavirus Disease (COVID-
                                                     19) Public Health Emergency
                                                     (Updated September 2021).
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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. CDER 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--CDER Guidances and Collections
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                                                                Another guidance title
      COVID-19 guidance title        CFR cite referenced in     referenced in COVID-19      OMB control No(s).
                                        COVID-19 guidance              guidance
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Development of Abbreviated New Drug  21 CFR 211.170, 21 CFR  (1) ANDAs: Stability         0910-0001, 0910-0014,
 Applications During the COVID-19     314.3, 21 CFR 314.50,   Testing of Drug Substances   0910-0119, 0910-0139,
 Pandemic--Questions and Answers;     21 CFR 314.94, 21 CFR   and Products, Questions      0910-0338, 0910-0581,
 Guidance for Industry (Updated       314.101, 21 CFR         and Answers.                 0910-0672, 0910-0733,
 September 2021).                     314.105, 21 CFR        (2) Referencing Approved      0910-0797.
                                      314.107, 21 CFR         Drug Products in ANDA
                                      320.25, 21 CFR          Submissions.
                                      320.31, 21 CFR         (3) Protecting Participants
                                      320.38, 21 CFR 320.63.  in Bioequivalence Studies
                                                              for Abbreviated New Drug
                                                              Applications During the
                                                              COVID-19 Public Health
                                                              Emergency.
                                                             (4) Safety Reporting
                                                              Requirements for INDs and
                                                              BA/BE Studies.
                                                             (5) Controlled
                                                              Correspondence Related to
                                                              Generic Drug Development.
                                                             (6) Formal Meetings Between
                                                              FDA and ANDA Applicants of
                                                              Complex Products Under
                                                              GDUFA.
                                                             (5) Controlled
                                                              Correspondence Related to
                                                              Generic Drug Development.
                                                             (7) Conduct of Clinical
                                                              Trials of Medical Products
                                                              during the COVID-19
                                                              Pandemic.
                                                             (8) ANDAs: Stability
                                                              Testing of Drug Substances
                                                              and Products, Questions
                                                              and Answers.
                                                             (9) Manufacturing, Supply
                                                              Chain, and Drug and
                                                              Biological Product
                                                              Inspections During COVID-
                                                              19 Public Health Emergency
                                                              Questions and Answers.
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B. CDRH Guidance

    While this guidance contains no collection of information, it does 
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 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:

[[Page 55623]]



                                     Table 3--CDRH 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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Enforcement Policy for Face Masks and     800, 801, and 809.........                                   0910-0485
 Respirators During the Coronavirus       803.......................                                   0910-0437
 Disease (COVID-19) Public Health         806.......................                                   0910-0359
 Emergency (Revised); Guidance for        807, subpart E............                                   0910-0120
 Industry and Food and Drug
 Administration Staff.
                                          807, subparts A through D.                                   0910-0625
                                          820.......................                                   0910-0073
                                          830 and 801.20............                                   0910-0720
                                                                      Emergency Use                    0910-0595
                                                                       Authorization of Medical
                                                                       Products and Related
                                                                       Authorities; Guidance for
                                                                       Industry and Other
                                                                       Stakeholders.
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IV. Withdrawn COVID-19-Related Guidance Documents

    On June 30, 2021, FDA announced the revocation of the Emergency Use 
Authorizations (EUAs) for Decontamination and Bioburden Reduction 
Systems for Personal Protective Equipment. The full text of the 
revocations are available electronically at https://www.regulations.gov 
(Docket No. FDA-2021-N-0762) and https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations. With the revocation of these 
EUAs, on June 30, 2021, FDA also withdrew two related decontamination 
and bioburden reduction guidance documents (listed in table 4), as the 
documents no longer represent the Agency's current thinking.

                  Table 4--Withdrawn Guidances Related to the COVID-19 Public Health Emergency
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             Docket No.                    Center          Title of withdrawn guidance         Withdrawal date
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FDA-2020-D-1138.....................  CDRH             Recommendations for Sponsors         June 30, 2021.
                                                        Requesting EUAs for
                                                        Decontamination and Bioburden
                                                        Reduction Systems for Face Masks
                                                        and Respirators During the
                                                        Coronavirus Disease 2019 (COVID-
                                                        19) Public Health Emergency;
                                                        Guidance for Industry and Food and
                                                        Drug Administration Staff.
FDA-2020-D-1138.....................  CDRH             Enforcement Policy for Bioburden     June 30, 2021.
                                                        Reduction Systems Using Dry Heat
                                                        to Support Single-User Reuse of
                                                        Certain Filtering Facepiece
                                                        Respirators During the Coronavirus
                                                        Disease (2019) Public Health
                                                        Emergency.
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    These withdrawn guidance documents are presented on FDA's website, 
for historical purposes only, at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-guidance.

V. 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: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21798 Filed 10-5-21; 8:45 am]
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