[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39048-39051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136 and 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 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 July 23, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

[[Page 39049]]

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.
    <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 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 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, 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-

[[Page 39050]]

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-1136.....................  CDER....................  Manufacturing, Supply    <a href="/cdn-cgi/l/email-protection#1c786e697b75727a735c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="caaeb8bfada3a4aca58aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a>.
                                                                 Chain, and Drug and      Please include the
                                                                 Biological Product       docket number FDA-2020-
                                                                 Inspections During       D-1136 and complete
                                                                 COVID-19 Public Health   title of the guidance
                                                                 Emergency Questions      in the request.
                                                                 and Answers (Updated
                                                                 May 2021).
FDA-2020-D-1137.....................  CBER....................  Emergency Use            Office of
                                                                 Authorization for        Communication,
                                                                 Vaccines to Prevent      Outreach and
                                                                 COVID-19 (Updated May    Development, 10903 New
                                                                 2021).                   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#ddb2beb2b99dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="e18e828e85a1878580cf898992cf868e97">[email protected]</span></a>.
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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
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
       COVID-19  guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                 Nos.
----------------------------------------------------------------------------------------------------------------
Manufacturing, Supply Chain, and Drug   21 CFR 314.50, 314.94,     --Prioritization of the             0910-0001
 and Biological Product Inspections      314.95, 314.125,           Review of Original ANDAs,          0910-0014
 During COVID-19 Public Health           314.127; 21 CFR 601.2      Amendments, and Supplements.       0910-0338
 Emergency Questions and Answers         and 601.20.               --Requests for Expedited            0910-0045
 (Updated May 2021).                                                Review of New Drug                 0910-0139
                                                                    Application and Biologics          0910-0759
                                                                    License Application Prior
                                                                    Approval Supplements
                                                                    Submitted for Chemistry,
                                                                    Manufacturing, and Controls
                                                                    Changes.
                                                                   --Administrative Processing
                                                                    of Original Biologics
                                                                    License Applications (BLA)
                                                                    and New Drug Applications
                                                                    (NDA).
                                                                   --Changes to an Approved
                                                                    Application for Specified
                                                                    Biotechnology and Specified
                                                                    Synthetic Biological
                                                                    Products.
                                                                   --Changes to an Approved
                                                                    Application: Biological
                                                                    Products.
                                                                   --Changes to an Approved NDA
                                                                    or ANDA; Questions and
                                                                    Answers.
                                                                   --Changes to an Approved NDA
                                                                    or ANDA.
                                                                   --CMC Postapproval
                                                                    Manufacturing Changes To Be
                                                                    Documented in Annual Reports.
                                                                   --Changes to an Approved
                                                                    Application: Biological
                                                                    Products: Human Blood and
                                                                    Blood Components Intended
                                                                    for Transfusion or for
                                                                    Further Manufacture.
                                                                   --CMC Postapproval
                                                                    Manufacturing Changes for
                                                                    Specified Biological
                                                                    Products To Be Documented in
                                                                    Annual Reports.
                                                                   --Chemistry, Manufacturing,
                                                                    and Controls Changes to an
                                                                    Approved Application:
                                                                    Certain Biological Products.
                                                                   --Immediate Release Solid
                                                                    Oral Dosage Forms; Scale-Up
                                                                    and Postapproval Changes:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls, In Vitro
                                                                    Dissolution Testing, and In
                                                                    Vivo Bioequivalence
                                                                    Documentation.
                                                                   --SUPAC-IR: Questions and
                                                                    Answers about SUPAC-IR
                                                                    Guidance.

[[Page 39051]]

 
                                                                   --SUPAC-SS: Nonsterile
                                                                    Semisolid Dosage Forms;
                                                                    Scale-Up and Postapproval
                                                                    Changes: Chemistry,
                                                                    Manufacturing, and Controls;
                                                                    In Vitro Release Testing and
                                                                    In Vivo Bioequivalence
                                                                    Documentation.
                                                                   --SUPAC-MR: Modified Release
                                                                    Solid Oral Dosage Forms;
                                                                    Scale-Up and Postapproval
                                                                    Changes: Chemistry,
                                                                    Manufacturing, and Controls;
                                                                    In Vitro Dissolution Testing
                                                                    and In Vivo Bioequivalence
                                                                    Documentation.
                                                                   --SUPAC: Manufacturing
                                                                    Equipment Addendum.
                                                                   --Remote Interactive
                                                                    Evaluations of Drug
                                                                    Manufacturing and
                                                                    Bioresearch Monitoring
                                                                    Facilities During the COVID-
                                                                    19 Public Health Emergency.
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B. CBER 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:

                                     Table 3--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                               COVID-19 guidance               guidance                Nos.
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for Vaccines  21 CFR 314.420............  Emergency Use                    0910-0001
 to Prevent COVID-19 (Updated May 2021).  21 CFR part 312...........   Authorization of Medical        0910-0014
                                          21 CFR parts 210, 211, and   Products and Related            0910-0139
                                           610.                        Authorities.
                                          21 CFR part 600...........                                   0910-0308
                                          21 CFR part 601...........                                   0910-0338
                                                                                                       0910-0595
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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 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: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15649 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


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