[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21744-21748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-0987, FDA-2020-D-1106, FDA-2020-D-1136, FDA-
2020-D-1137, FDA-2020-D-1825]


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 April 23, 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 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.

[[Page 21745]]

    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, 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'' (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
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1825.................  CBER................  Investigational COVID-19     Office of Communication,
                                                         Convalescent Plasma          Outreach and Development,
                                                         (Updated February 2021).     10903 New Hampshire Ave.,
                                                                                      Bldg. 71, Rm. 3128, Silver
                                                                                      Spring, MD 20993-0002, 1-
                                                                                      800-835-4709 or 240-402-
                                                                                      8010; email
                                                                                      [email protected].
FDA-2020-D-1137.................  CBER................  Emergency Use Authorization  Office of Communication,
                                                         for Vaccines to Prevent      Outreach and Development,
                                                         COVID-19 (Updated February   10903 New Hampshire Ave.,
                                                         2021).                       Bldg. 71, Rm. 3128, Silver
                                                                                      Spring, MD 20993-0002, 1-
                                                                                      800-835-4709 or 240-402-
                                                                                      8010; email
                                                                                      [email protected].
FDA-2020-D-1136.................  CDER................  COVID-19 Container Closure   [email protected].
                                                         System and Component        Please include the docket
                                                         Changes: Glass Vials and     number FDA-2020-D-1136 and
                                                         Stoppers Guidance for        complete title of the
                                                         Industry (March 2021).       guidance in the request.
FDA-2020-D-1136.................  CDER................  Development of Monoclonal    [email protected].
                                                         Antibody Products           Please include the docket
                                                         Targeting SARS-CoV-2,        number FDA-2020-D-1136 and
                                                         Including Addressing the     complete title of the
                                                         Impact of Emerging           guidance in the request.
                                                         Variants, During the COVID
                                                         19 Public Health Emergency
                                                         (February 2021).

[[Page 21746]]

 
FDA-2020-D-1106.................  CDER................  Temporary Policy for         [email protected].
                                                         Manufacture of Alcohol for  Please include the docket
                                                         Incorporation Into Alcohol-  number FDA-2020-D-1106 and
                                                         Based Hand Sanitizer         complete title of the
                                                         Products During the Public   guidance in the request.
                                                         Health Emergency (COVID-
                                                         19) (Updated February
                                                         2021).
FDA-2020-D-1106.................  CDER................  Temporary Policy for         [email protected].
                                                         Preparation of Certain      Please include the docket
                                                         Alcohol-Based Hand           number FDA-2020-D-1106 and
                                                         Sanitizer Products During    complete title of the
                                                         the Public Health            guidance in the request.
                                                         Emergency (COVID-19)
                                                         (Updated February 2021).
FDA-2020-D-0987.................  CDRH................  Policy for Evaluating        [email protected].
                                                         Impact of Viral Mutations    Please include the
                                                         on COVID-19 Tests            document number 21104 and
                                                         (February 2021).             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 Guidances

    While these guidances contain no collection of information, they do 
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 these guidances. 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 Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for         21 CFR 314.420...........                                      0910-0001
 Vaccines to Prevent COVID-19           21 CFR part 312..........  .............................       0910-0014
 (Updated: February 22, 2021).          21 CFR parts 210, 211,     .............................       0910-0139
                                         and 610.                  .............................       0910-0308
                                        21 CFR part 600..........  .............................       0910-0338
                                        21 CFR part 601..........
                                                                   Emergency Use Authorization         0910-0595
                                                                    of Medical Products and
                                                                    Related Authorities.
Investigational COVID-19 Convalescent   21 CFR part 312..........                                      0910-0014
 Plasma; Guidance for Industry          21 CFR parts 606 and 630.  .............................       0910-0116
 (Updated: February 11, 2021).
                                                                   Form FDA 3926................       0910-0814
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B. CDER 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. 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 3--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                No(s).
----------------------------------------------------------------------------------------------------------------
COVID-19 Container Closure System and   21 CFR 314.70............  Requests for Expedited Review       0910-0001
 Component Changes: Glass Vials and     21 CFR 314.97............   of New Drug Application and        0910-0338
 Stoppers Guidance for Industry (March  21 CFR 601.12............   Biologics License                  0910-0139
 2021).                                 21 CFR 314.420...........   Application Prior Approval
                                                                    Supplements Submitted for
                                                                    Chemistry, Manufacturing,
                                                                    and Controls Changes.
                                                                   Comparability Protocols for
                                                                    Human Drugs and Biologics:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls Information
                                                                    (April 2016).
                                                                   Chemistry, Manufacturing, and
                                                                    Controls Changes to an
                                                                    Approved Application:
                                                                    Certain Biological Products
                                                                    (December 2017).
                                                                   Changes to an Approved
                                                                    Application for Specified
                                                                    Biotechnology and Specified
                                                                    Synthetic Biological
                                                                    Products (July 1997).
                                                                   Changes to an Approved NDA or
                                                                    ANDA (April 2004).
                                                                   Container Closure Systems for
                                                                    Packaging Human Drugs and
                                                                    Biologics; Chemistry,
                                                                    Manufacturing, and Controls
                                                                    Documentation (May 1999).
                                                                   CMC Postapproval
                                                                    Manufacturing Changes for
                                                                    Specified Biological
                                                                    Products To Be Documented in
                                                                    Annual Reports (August 2017).
                                                                   Comparability Protocols for
                                                                    Human Drugs and Biologics:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls Information
                                                                    (April 2016).
                                                                   Drug Master Files (October
                                                                    2019).
                                                                   Harmonizing Compendial
                                                                    Standards With Drug
                                                                    Application Approval Using
                                                                    the USP Pending Monograph
                                                                    Process (July 2019).

[[Page 21747]]

 
                                                                   Manufacturing, Supply Chain,
                                                                    and Drug and Biological
                                                                    Product Inspections During
                                                                    COVID-19 Public Health
                                                                    Emergency; Questions and
                                                                    Answers (August 2020).
                                                                   PAC-ATLS: Postapproval
                                                                    Changes--Analytical Testing
                                                                    Laboratory Sites (April
                                                                    1998).
                                                                   Submission Documentation for
                                                                    Sterilization Process
                                                                    Validation in Applications
                                                                    for Human and Veterinary
                                                                    Drug Products (November
                                                                    1994).
                                                                   Immediate Release Solid Oral
                                                                    Dosage Forms; Scale-Up and
                                                                    Postapproval Changes:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls, In Vitro
                                                                    Dissolution Testing, and In
                                                                    Vivo Bioequivalence
                                                                    Documentation (November
                                                                    1995).
                                                                   Nonsterile Semisolid Dosage
                                                                    Forms; Scale-Up and
                                                                    Postapproval Changes:
                                                                    Chemistry, Manufacturing,
                                                                    and Controls; In Vitro
                                                                    Release Testing and In Vivo
                                                                    Bioequivalence Documentation
                                                                    (May 1997).
                                                                   SUPAC: Manufacturing
                                                                    Equipment Addendum (December
                                                                    2014).
                                                                   SUPAC-IR: Questions and
                                                                    Answers about SUPAC-IR
                                                                    Guidance (February 1997).
                                                                   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 (September
                                                                    1997).
                                                                   Q6A Specifications: Test
                                                                    Procedures and Acceptance
                                                                    Criteria for New Drug
                                                                    Substances and New Drug
                                                                    Products: Chemical
                                                                    Substances (December 2000).
                                                                   Q6B Specifications: Test
                                                                    Procedures and Acceptance
                                                                    Criteria for
                                                                    Biotechnological/Biological
                                                                    Products (August 1999).
                                                                   Q9 Quality Risk Management
                                                                    (June 2006).
                                                                   Q10 Pharmaceutical Quality
                                                                    System (April 2009).
Development of Monoclonal Antibody      21 CFR 312...............  Emergency Use Authorization         0910-0014
 Products Targeting SARS-CoV-2,         21 CFR 601.20............   of Medical Products and            0910-0001
 Including Addressing the Impact of                                 Related Authorities (January       0910-0338
 Emerging Variants, During the COVID-                               2017).                             0910-0139
 19 Public Health Emergency (February
 2021).
                                                                   COVID-19: Potency Assay
                                                                    Considerations for
                                                                    Monoclonal Antibodies and
                                                                    Other Therapeutic Proteins
                                                                    Targeting SARS-CoV-2
                                                                    Infectivity (January 2021).
                                                                   S6(R1) Preclinical Safety
                                                                    Evaluation of Biotechnology-
                                                                    Delivered Pharmaceuticals
                                                                    (May 2012).
                                                                   CGMP for Phase 1
                                                                    Investigational Drugs (July
                                                                    2008)..
                                                                   COVID-19 Public Health
                                                                    Emergency: General
                                                                    Considerations for Pre-IND
                                                                    Meeting Requests for COVID-
                                                                    19 Related Drugs and
                                                                    Biological Products.
                                                                   Points to Consider in the
                                                                    Manufacture and Testing of
                                                                    Monoclonal Antibody Products
                                                                    for Human Use (February
                                                                    1997)..
                                                                   COVID-19: Developing Drugs
                                                                    and Biological Products for
                                                                    Treatment or Prevention
                                                                    (February 2021).
                                                                   Antiviral Product
                                                                    Development--Conducting and
                                                                    Submitting Virology Studies
                                                                    to the Agency (June 2006).
Temporary Policy for Preparation of                                Temporary Compounding of            0910-0045
 Certain Alcohol-Based Hand Sanitizer                               Certain Alcohol-Based Hand         0910-0139
 Products During the Public Health                                  Sanitizer Products During          0910-0230
 Emergency (COVID-19) (Updated                                      the Public Health Emergency        0910-0291
 February 10, 2021).                                                (COVID-19).                        0910-0340
                                                                                                       0910-0641
                                                                                                       0910-0645
                                                                                                       0910-0800
                                                                   Temporary Policy for
                                                                    Manufacture of Alcohol for
                                                                    Incorporation Into Alcohol-
                                                                    Based Hand Sanitizer
                                                                    Products During the Public
                                                                    Health Emergency (COVID-19).
                                                                   Adverse Event Reporting
                                                                    Requirements.
                                                                   Policy for Testing of Alcohol
                                                                    (Ethanol) and Isopropyl
                                                                    Alcohol for Methanol,
                                                                    Including During the Public
                                                                    Health Emergency (COVID-19).
                                                                   Q3C Guideline on Impurities:
                                                                    Guideline for Residual
                                                                    Solvents.
Temporary Policy for Manufacture of     21 CFR 207.17............  Temporary Policy for                0910-0045
 Alcohol for Incorporation Into         21 CFR 207.25............   Preparation of Certain             0910-0139
 Alcohol-Based Hand Sanitizer Products  21 CFR 207.41............   Alcohol-Based Hand Sanitizer       0910-0230
 During the Public Health Emergency                                 Products During the Public         0910-0291
 (COVID-19) (Updated February 10,                                   Health Emergency (COVID-19).       0910-0340
 2021).                                                                                                0910-0641
                                                                   Policy for Testing of Alcohol
                                                                    (Ethanol) and Isopropyl
                                                                    Alcohol for Methanol,
                                                                    Including During the Public
                                                                    Health Emergency (COVID-19).
                                                                   Q3C Guideline on Impurities:
                                                                    Guideline for Residual
                                                                    Solvents.
----------------------------------------------------------------------------------------------------------------

C. CDRH Guidance

    While this guidance contains no collection of information, it does 
refer to a previously approved FDA collection of information (listed in 
table 4). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved 
collection of information is subject to review by OMB under the PRA. 
The collection of information in the following FDA guidance has been 
approved by OMB as listed in the following table:

[[Page 21748]]



                                     Table 4--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
Policy for Evaluating Impact of Viral                              Emergency Use Authorization         0910-0595
 Mutations on COVID-19 Tests (February                              of Medical Products and
 2021).                                                             Related Authorities;
                                                                    Guidance for Industry and
                                                                    Other Stakeholders.
----------------------------------------------------------------------------------------------------------------

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 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08474 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P