[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Notices]
[Pages 55678-55682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106 and FDA-2020-D-1138]


Guidance Documents Related to Coronavirus Disease 2019; 
Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of FDA guidance documents related to the Coronavirus 
Disease 2019 (COVID-19) public health emergency (PHE). This notice of 
availability (NOA) is pursuant to the process that FDA announced, in 
the Federal Register of March 25, 2020, for making available to the 
public COVID-19-related guidances. The guidances identified in this 
notice address issues related to the COVID-19 PHE and have been issued 
in accordance with the process announced in the March 25, 2020, notice. 
The guidance documents 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 September 9, 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 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

[[Page 55679]]

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 document.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; or Erica Takai, Center for Devices and Radiological Health 
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5456, (HFZ-450), 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, Alex 
M. Azar II, Secretary of Health and Human Services, pursuant to the 
authority under section 319 of the Public Health Service Act (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; on July 23, 2020, it was extended again, 
effective July 25, 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 guidance documents 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 guidance 
documents. Therefore, FDA will issue COVID-19-related guidance 
documents 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 Sec.  10.115(g)(2). The 
guidances are available at FDA's web page titled ``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 titled ``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 
document, 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 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-1106...................  Center for Drug        Temporary Policy for        [email protected],
                                     Evaluation and         Preparation of Certain      Please include the
                                     Research (CDER).       Alcohol-Based Hand          docket number FDA-2020-D-
                                                            Sanitizer Products During   1106 and complete title
                                                            the Public Health           of the guidance in the
                                                            Emergency (COVID-19)        request.
                                                            (March 2020) (Updated
                                                            August 7, 2020).
FDA-2020-D-1106...................  CDER.................  Policy for Temporary        [email protected],
                                                            Compounding of Certain      Please include the
                                                            Alcohol-Based Hand          docket number FDA-2020-D-
                                                            Sanitizer Products During   1106 and complete title
                                                            the Public Health           of the guidance in the
                                                            Emergency (March 2020)      request.
                                                            (Updated August 7, 2020).

[[Page 55680]]

 
FDA-2020-D-1106...................  CDER.................  Temporary Policy for        [email protected],
                                                            Manufacture of Alcohol      Please include the
                                                            for Incorporation Into      docket number FDA-2020-D-
                                                            Alcohol-Based Hand          1106 and complete title
                                                            Sanitizer Products During   of the guidance in the
                                                            the Public Health           request.
                                                            Emergency (COVID-19)
                                                            (March 2020) (Updated
                                                            August 7, 2020).
FDA-2020-D-1138...................  Center for Devices     Enforcement Policy for      CDRH-
                                     and Radiological       Viral Transport Media       [email protected],
                                     Health (CDRH).         During the Coronavirus      Please include the
                                                            Disease 2019 (COVID-19)     document number 20038
                                                            Public Health Emergency     and complete title of
                                                            (July 2020).                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. CDER Guidances

    The guidances listed in the table below refer 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 Act of 1995 (PRA) (44 U.S.C. 3501-3521). 
The collections of information in the following FDA regulations and 
guidances have been approved by OMB as listed in the table below. These 
guidances also contain a collection of information not approved under a 
current collection. This collection of information has been granted a 
PHE waiver from the PRA by the Department of Health and Human Services 
(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 2--CDER Guidances and Collections
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                                           CFR cite(s)
      COVID-19 guidance title        referenced in COVID-19  Another guidance referenced    OMB Control  No(s).
                                             guidance            in COVID-19 guidance
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Temporary Policy for Preparation of  27 CFR parts 20 and 21  --Policy for Temporary       0910-0045, 0910-0139,
 Certain Alcohol-Based Hand                                   Compounding of Certain       0910-0230, 0910-0291,
 Sanitizer Products During the                                Alcohol-Based Hand           0910-0340, 0910-0641,
 Public Health Emergency (COVID-                              Sanitizer Products During    0910-0645, 0910-0800.
 19)--UPDATE of guidance announced                            the Public Health
 in March 2020.                                               Emergency.
                                                             --Temporary Policy for
                                                              Manufacture of Alcohol for
                                                              Incorporation Into Alcohol-
                                                              Based Hand Sanitizer
                                                              Products During the Public
                                                              Health Emergency (COVID-
                                                              19).
                                                             --Providing Regulatory
                                                              Submissions in Electronic
                                                              Format--Drug Establishment
                                                              Registration and Drug
                                                              Listing.
                                                             --Postmarketing Adverse
                                                              Event Reporting for
                                                              Nonprescription Human Drug
                                                              Products Marketed Without
                                                              an Approved Application.
Temporary Policy for Manufacture of  27 CFR parts 20 and 21  --Policy for Temporary       0910-0045, 0910-0139,
 Alcohol for Incorporation Into                               Compounding of Certain       0910-0230, 0910-0291,
 Alcohol-Based Hand Sanitizer                                 Alcohol-Based Hand           0910-0340, 0910-0641,
 Products During the Public Health                            Sanitizer Products During    0910-0645.
 Emergency (COVID-19)--UPDATE of                              the Public Health
 guidance announced in March 2020.                            Emergency.
                                                             --Temporary Policy for
                                                              Preparation of Certain
                                                              Alcohol-Based Hand
                                                              Sanitizer Products During
                                                              the Public Health
                                                              Emergency (COVID-19).
                                                             --Providing Regulatory
                                                              Submissions in Electronic
                                                              Format--Drug Establishment
                                                              Registration and Drug
                                                              Listing.

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Policy for Temporary Compounding of  ......................  --Current Good               0910-0045, 0910-0139,
 Certain Alcohol-Based Hand                                   Manufacturing Practices      0910-0230, 0910-0291,
 Sanitizer Products During the                                for Finished                 0910-0340, 0910-0641,
 Public Health Emergency--UPDATE of                           Pharmaceuticals and          0910-0645.
 guidance announced in March 2020.                            Medical Gases.
                                                             --Postmarketing Adverse
                                                              Drug Experience Reporting..
                                                             --MedWatch: Adverse Event
                                                              and Product Experience
                                                              Reporting System (Paper-
                                                              Based).
                                                             --Format and Content
                                                              Requirements for Over-the-
                                                              Counter Drug Product
                                                              Labeling.
                                                             --FDA Adverse Event and
                                                              Product Experience
                                                              Reports; Electronic
                                                              Submissions.
                                                             --Adverse Event Reporting
                                                              for Outsourcing Facilities
                                                              Under Section 503B of the
                                                              Federal Food, Drug, and
                                                              Cosmetic Act.
                                                             --Temporary Policy for
                                                              Preparation of Certain
                                                              Alcohol-Based Hand
                                                              Sanitizer Products During
                                                              the Public Health
                                                              Emergency (COVID-19).
                                                             --Temporary Policy for
                                                              Manufacture of Alcohol for
                                                              Incorporation Into Alcohol-
                                                              Based Hand Sanitizer
                                                              Products During the Public
                                                              Health Emergency (COVID-
                                                              19).
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B. CDRH Guidances

    The guidance indicated in the table below refers to previously 
approved collections of information. These collections of information 
are subject to review by the OMB under the PRA. The collections of 
information in the following FDA regulations and guidance have been 
approved by OMB as listed in the table below. 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 3--CDRH Guidances and Collections
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                                    CFR cites(s)      Another guidance                           New collection
    COVID-19 guidance title        referenced  in      referenced  in     OMB Control  No(s).   covered by  PHE
                                  COVID-19 guidance   COVID-19 guidance                            PRA waiver
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Enforcement Policy for Viral                         Emergency Use       0910-0595             .................
 Transport Media During the                           Authorization of
 Coronavirus Disease 2019                             Medical Products
 (COVID-19) Public Health                             and Related
 Emergency (July 2020).                               Authorities;
                                                      Guidance for
                                                      Industry and
                                                      Other
                                                      Stakeholders.
                                                     Administrative      0910-0607             .................
                                                      Procedures for
                                                      Clinical
                                                      Laboratory
                                                      Improvement
                                                      Amendments of
                                                      1988
                                                      Categorization.
                                 21 CFR parts 800,   ..................  0910-0485             .................
                                  801, and 809.
                                 21 CFR part 803...  ..................  0910-0437             .................
                                 21 CFR part 806...  ..................  0910-0359             .................
                                 21 CFR part 807,    ..................  0910-0625             .................
                                  subparts A
                                  through D.
                                 21 CFR part 807,    ..................  0910-0120             .................
                                  subpart E.
                                 21 CFR part 820...  ..................  0910-0073             .................
                                 21 CFR part 830     ..................  0910-0720             .................
                                  and 21 CFR 801.20.
                                                                                               Manufacturer
                                                                                                voluntary
                                                                                                reporting to FDA
                                                                                                of viral
                                                                                                transport media
                                                                                                manufacturing
                                                                                                capacity
                                                                                                information.
                                                                                               Manufacturer
                                                                                                voluntary
                                                                                                reporting to FDA
                                                                                                of sterile
                                                                                                phosphate
                                                                                                buffered saline/
                                                                                                saline
                                                                                                manufacturing
                                                                                                capacity
                                                                                                information.
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[[Page 55682]]

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: September 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19883 Filed 9-8-20; 8:45 am]
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