[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31513-31520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11238]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1136, FDA-2020-D-1137, FDA-2020-D-1138, FDA-
2020-D-1139]


Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); 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 May 26, 2020. The guidances have been implemented without 
prior comment, but they remain subject to comment in accordance with 
the Agency's good guidance practices.

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(s) 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.
     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

[[Page 31514]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)). Submit written requests for single copies of any of 
these guidances to the addresses 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 document.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-
402-7911; 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; 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; Phil Chao, Center for Food Safety 
and Applied Nutrition (CFSAN), CPK1 Rm 1C001, HFS-024, Food and Drug 
Administration, College Park, MD 20740, 240-402-2112.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19, 
and after consultation with public health officials as necessary, Alex 
M. Azar II, Secretary of Health and Human Services, pursuant to the 
authority under section 319 of the Public Health Service Act (42 U.S.C. 
247d) (PHS Act), determined that a PHE exists and has existed since 
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J. 
Trump declared that the COVID-19 outbreak in the United States 
constitutes a national emergency, beginning March 1, 2020.\2\
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    \1\ On April 21, 2020, the PHE Determination was extended, 
effective April 26, 2020. These PHE Determinations are available at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning 
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), 
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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    In the Federal Register of March 25, 2020 (the March 25, 2020, 
notice) (available at: https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available 
FDA guidances related to the COVID-19 PHE. These procedures, which 
operate within FDA's established good guidance practices regulations, 
are intended to allow FDA to rapidly disseminate Agency recommendations 
and policies related to COVID-19 to industry, FDA staff, and other 
stakeholders. The March 25, 2020, notice stated that due to the need to 
act quickly and efficiently to respond to the COVID-19 PHE, FDA 
believes that prior public participation will not be feasible or 
appropriate before FDA implements COVID-19-related guidances. 
Therefore, FDA will issue COVID-19-related guidances for immediate 
implementation without prior public comment (see section 701(h)(1)(C) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec.  10.115(g)(2))). The 
guidances are available at FDA's web page entitled ``COVID-19-Related 
Guidance Documents for Industry, FDA Staff, and Other Stakeholders'' 
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled ``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 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 Guidances

    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
----------------------------------------------------------------------------------------------------------------
                                                                                         Contact information to
            Docket No.                   Center/office          Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137...................  CBER                    Investigatory COVID-19     Office of Communication,
                                                             Convalescent Plasma        Outreach and
                                                             (April 2020) (Updated      Development, 10903 New
                                                             May 1, 2020).              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-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Clinical Electronic       Please include the
                                                             Thermometers During the    document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 4,        request.
                                                             2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Infusion Pumps and        Please include the
                                                             Accessories During the     document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 5,        request.
                                                             2020).

[[Page 31515]]

 
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Remote Ophthalmic         Please include the
                                                             Assessment and             document number 20014
                                                             Monitoring Devices         and complete title of
                                                             During the Coronavirus     the guidance in the
                                                             Disease 2019 (COVID-19)    request.
                                                             Public Health Emergency
                                                             (April 6, 2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Extracorporeal Membrane   Please include the
                                                             Oxygenation and            document number 20014
                                                             Cardiopulmonary Bypass     and complete title of
                                                             Devices During the         the guidance in the
                                                             Coronavirus Disease 2019   request.
                                                             (COVID-19) Public Health
                                                             Emergency (April 6,
                                                             2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Digital Health Devices    Please include the
                                                             for Treating               document number 20014
                                                             Psychological Disorders    and complete title of
                                                             During the Coronavirus     the guidance in the
                                                             Disease 2019 (COVID-19)    request.
                                                             Public Health Emergency
                                                             (April 14, 2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Telethermographic         Please include the
                                                             Systems During the         document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 16,       request.
                                                             2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Non-Invasive Fetal and    Please include the
                                                             Maternal Monitoring        document number 20014
                                                             Devices Used to Support    and complete title of
                                                             Patient Monitoring         the guidance in the
                                                             During the Coronavirus     request.
                                                             Disease 2019 (COVID-19)
                                                             Public Health Emergency
                                                             (April 23, 2020).
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Imaging Systems During    Please include the
                                                             the Coronavirus Disease    document number 20014
                                                             2019 (COVID-19) Public     and complete title of
                                                             Health Emergency (April    the guidance in the
                                                             23, 2020).                 request.
FDA-2020-D-1138...................  CDRH                    Enforcement Policy for     [email protected]
                                                             Remote Digital Pathology  Please include the
                                                             Devices During the         document number 20014
                                                             Coronavirus Disease 2019   and complete title of
                                                             (COVID-19) Public Health   the guidance in the
                                                             Emergency (April 24,       request.
                                                             2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy           [email protected]
                                                             Regarding Non-Standard    Please include the docket
                                                             PPE Practices for          number FDA-2020-D-1136
                                                             Sterile Compounding by     and complete title of
                                                             Pharmacy Compounders not   the guidance in the
                                                             Registered as              request.
                                                             Outsourcing Facilities
                                                             During the COVID-19
                                                             Public Health Emergency
                                                             (April 10, 2020).
FDA-2020-D-1136...................  CDER                    Policy for the Temporary   [email protected]
                                                             Use of Portable           Please include the docket
                                                             Cryogenic Containers Not   number FDA-2020-D-1136
                                                             in Compliance With 21      and complete title of
                                                             CFR 211.94(e)(1) For       the guidance in the
                                                             Oxygen and Nitrogen        request.
                                                             During the COVID-19
                                                             Public Health Emergency
                                                             (April 2020) (Updated
                                                             April 20, 2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy for       [email protected]
                                                             Compounding of Certain    Please include the docket
                                                             Drugs for Hospitalized     number FDA-2020-D-1136
                                                             Patients by Outsourcing    and complete title of
                                                             Facilities During the      the guidance in the
                                                             COVID-19 Public Health     request.
                                                             Emergency (April 16,
                                                             2020) (Updated May 8,
                                                             2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy for       [email protected]
                                                             Compounding of Certain    Please include the docket
                                                             Drugs for Hospitalized     number FDA-2020-D-1136
                                                             Patients by Pharmacy       and complete title of
                                                             Compounders not            the guidance in the
                                                             Registered as              request.
                                                             Outsourcing Facilities
                                                             During the COVID-19
                                                             Public Health Emergency
                                                             Guidance for Industry
                                                             (April 20, 2020)
                                                             (Updated May 8, 2020).
FDA-2020-D-1136...................  CDER                    Temporary Policy on        [email protected]
                                                             Repackaging or Combining  Please include the docket
                                                             Propofol Drug Products     number FDA-2020-D-1136
                                                             During the COVID-19        and complete title of
                                                             Public Health Emergency    the guidance in the
                                                             (April 22, 2020).          request.
FDA-2020-D-1139...................  CFSAN                   Temporary Policy on        Office of Nutrition and
                                                             Regulatory Enforcement     Food Labeling, Food
                                                             of 21 CFR Part 118 (the    Labeling and Standards
                                                             Egg Safety Rule) During    Staff, Center for Food
                                                             the COVID-19 Public        Safety and Applied
                                                             Health Emergency (April    Nutrition, Food and Drug
                                                             6, 2020).                  Administration, 5001
                                                                                        Campus Dr., College
                                                                                        Park, MD 20740.
----------------------------------------------------------------------------------------------------------------

    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

    The guidance indicated below refers to previously approved 
collections of information. These collections of information are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction

[[Page 31516]]

Act of 1995 (44 U.S.C. 3501-3521) (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 Guidance
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                              COVID-19  guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Investigatory COVID-19 Convalescent       21 CFR part 312...........  N/A.......................       0910-0014
 Plasma.                                  >21 CFR 606.121...........  ..........................       0910-0116
                                          21 CFR part 630...........  ..........................       0910-0116
                                          Form FDA 3926.............  ..........................       0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDRH

    The guidances listed below refer to previously approved collections 
of information. These 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:
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BILLING CODE 4164-01-C

C. CDER

    The guidances listed below refer to previously approved collections 
of information. These 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 4--Guidances and Regulations
----------------------------------------------------------------------------------------------------------------
                                            CFR or FD&C Act cite
        COVID-19 guidance title            referenced in COVID-19        Another guidance title      OMB control
                                                  guidance               referenced in COVID-19         No(s).
--------------------------------------------------------------------------------guidance------------------------
Policy for Temporary Use of Portable     21 CFR parts 201, 210,      Current Good Manufacturing        0910-0139
 Cryogenic Containers Not in Compliance   211.84, 211.94, and         Practice for Medical Gases
 With 21 CFR 211.94 for Oxygen and        211.100.                    Medical Gas Containers and
 Nitrogen During COVID-19 Public Health                               Closures; Current Good
 Emergency.                                                           Manufacturing Practice
                                                                      Requirements.
Temporary Policy for Compounding of      21 CFR 314.81, 21 CFR       Current Good Manufacturing        0910-0777
 Certain Drugs for Hospitalized           600.82, Section             Practice--Guidance for Human     0910-0338
 Patients by Outsourcing Facilities       503B(b)(1)(A)(i) of the     Drug Compounding Outsourcing     0910-0001
 During the COVID-19 Public Health        FD&C Act (21 U.S.C.         Facilities Under Section 503B    0910-0139
 Emergency.                               353b(b)(1)(A)(i).           of the FD&C Act.

[[Page 31519]]

 
Temporary Policy for Compounding of      ..........................  Compounded Drug Products That     0910-0001
 Certain Drugs for Hospitalized                                       are Essentially Copies of a      0910-0139
 Patients by Pharmacy Compounders not                                 Commercially Available Drug      0910-0338
 Registered as Outsourcing Facilities                                 Product under Section 503A of
 During the COVID-19 Public Health                                    the Federal Food, Drug and
 Emergency.                                                           Cosmetic Act.
                                                                     Temporary Policy for
                                                                      Compounding of Certain Drugs
                                                                      for Hospitalized Patients by
                                                                      Outsourcing Facilities During
                                                                      the COVID-19 Public Health
                                                                      Emergency.
                                                                     Prescription Requirement Under
                                                                      Section 503A of the Federal
                                                                      Food, Drug, and Cosmetic Act.
                                                                     Temporary Policy Regarding Non-
                                                                      Standard PPE Practices for
                                                                      Sterile Compounding by
                                                                      Pharmacy Compounders not
                                                                      Registered as Outsourcing
                                                                      Facilities during the COVID-
                                                                      19 Public Health Emergency.
Temporary Policy on Repackaging or       ..........................  Repackaging of Certain Human      0910-0139
 Combining Propofol Drug Products                                     Drugs by Pharmacies and          0910-0572
 During the COVID-19 Public Health                                    Outsourcing Facilities.          0910-0777
 Emergency.                                                          Temporary Policy for              0910-0800
                                                                      Compounding of Certain Drugs
                                                                      for Hospitalized Patients by
                                                                      Pharmacy Compounders not
                                                                      Registered as Outsourcing
                                                                      Facilities During the COVID-
                                                                      19 Public Health Emergency.
                                                                     Temporary Policy for
                                                                      Compounding of Certain Drugs
                                                                      for Hospitalized Patients by
                                                                      Outsourcing Facilities During
                                                                      the COVID-19 Public Health
                                                                      Emergency.
----------------------------------------------------------------------------------------------------------------

    The guidance indicated below refers to previously approved 
collections of information. These 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 below table. This guidance also contains a new 
collection of information not approved under a current collection. This 
new collection of information has been granted a PHE waiver from the 
PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act. 
Information concerning the PHE PRA waiver can be found on the HHS 
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 5--New PRA Information Collection
----------------------------------------------------------------------------------------------------------------
                                      CFR cite          Another guidance
    COVID-19 guidance title         referenced in    referenced in COVID-19  OMB control  New collection covered
                                  COVID-19 guidance         guidance             No.         by PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Non-  21 CFR parts 210    Enforcement Policy for    0910-0139  Recordkeeping of
 Standard PPE Practices for       and 211.            Face Masks and                       compounding without
 Sterile Compounding by                               Respirators During                   standard PPE;
 Pharmacy Compounders not                             the Coronavirus                      recordkeeping of any
 Registered as Outsourcing                            Disease (COVID-19)                   change of
 Facilities During the COVID-19                       Public Health                        sterilization/aseptic
 Public Health Emergency.                             Emergency (Revised).                 processing methods;
                                                     Enforcement Policy for                documentation of
                                                      Gowns, Other Apparel,                mitigation strategies
                                                      and Gloves During the                for sterile
                                                      Coronavirus Disease                  compounding without
                                                      (COVID-19) Public                    standard PPE.
                                                      Health Emergency.
                                                     Electronic Drug
                                                      Product Reporting for
                                                      Human Drug
                                                      Compounding
                                                      Outsourcing
                                                      Facilities Under
                                                      Section 503B of the
                                                      Federal Food, Drug,
                                                      and Cosmetic Act.
----------------------------------------------------------------------------------------------------------------

D. CFSAN

    The guidance indicated below refers to previously approved 
collections of information. These 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 31520]]



                                             Table 6--CFSAN Guidance
----------------------------------------------------------------------------------------------------------------
                                                                           Another guidance title
         COVID-19 guidance title              CFR cite referenced in       referenced in COVID-19    OMB control
                                                COVID-19 guidance                 guidance               No.
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Enforcement of  21 CFR part 118............  ...........................    0910-0660
 21 CFR Part 118 (the Egg Safety Rule)
 During the COVID-19 Public Health
 Emergency.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related 
guidances at:
     the 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;
     the 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: May 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11238 Filed 5-22-20; 8:45 am]
BILLING CODE 4164-01-P