[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28010-28016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1137, FDA-2020-D-1138, FDA-
2020-D-1139, and FDA-2020-D-1140]


Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

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 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, document. 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 May 12, 2020. The guidance documents 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:

[[Page 28011]]

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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    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 any of these guidances 
to the addresses noted in table 1. Where applicable, 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; Erica Takai, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, 
Silver Spring, MD 20993-0002, 301-796-6353; Phil Chao, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2112; Kimberly Thomas, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; Diane Heinz, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5692.

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 (HHS), pursuant to 
the authority under section 319 of the Public Health Service Act (PHS 
Act) (42 U.S.C. 247d), 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 (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 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 on FDA's web page ``COVID-19-Related Guidance 
Documents for Industry, FDA Staff, and Other Stakeholders'' (https://
www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-

[[Page 28012]]

related-guidance-documents-industry-fda-staff-and-other-stakeholders) 
and through FDA's web page ``Search for FDA Guidance Documents'' 
(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 notice of availability (NOA) for each COVID-
19-related guidance document, FDA intends to publish periodically a 
consolidated NOA announcing the availability of COVID-19-related 
guidance documents FDA issued during the relevant period. This notice 
announces certain COVID-19-related guidances that are posted on FDA's 
website, as included in table 1.
    Lastly, the March 25, 2020, notice indicated that, in general, 
guidance documents would be placed in dockets established for COVID-19-
related guidance documents issued by each Center. As noted in table 1, 
certain COVID-19-related guidance documents issued by the Center for 
Drug Evaluation and Research (CDER) prior to March 24, 2020, were 
placed in Docket No. FDA-2020-D-1106. FDA anticipates that, in general, 
CDER will use Docket No. FDA-2020-D-1136 for additional COVID-19-
related guidance documents issued pursuant to the process described in 
the March 25, 2020, notice.

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 
guidance documents:

                       Table 1-- Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                  Contact information to request
       Docket No.             Center/office              Title of guidance                 single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137........  Center for Biologics     Alternative Procedures for      Office of Communication,
                          Evaluation and           Blood and Blood Components      Outreach and Development,
                          Research (CBER).         During the COVID-19 Public      Center for Biologics
                                                   Health Emergency (April 2020).  Evaluation and Research,
                                                                                   10903 New Hampshire Ave.,
                                                                                   Bldg. 71, Rm. 3128, Silver
                                                                                   Spring, MD 20993-0002, 1-800-
                                                                                   835-4709 or 240-402-8010;
                                                                                   email ocod@fda.hhs.gov.
FDA-2020-D-1138........  Center for Devices and   Enforcement Policy for Non-     CDRH-Guidance@fda.hhs.gov.
                          Radiological Health      Invasive Remote Monitoring      Please include the document
                          (CDRH).                  Devices Used to Support         number 20014 and complete
                                                   Patient Monitoring During the   title of the guidance in the
                                                   Coronavirus Disease-2019        request.
                                                   (COVID-19) Public Health
                                                   Emergency (March 2020).
FDA-2020-D-1138........  CDRH...................  Enforcement Policy for          CDRH-Guidance@fda.hhs.gov.
                                                   Ventilators and Accessories     Please include the document
                                                   and Other Respiratory Devices   number 20015 and complete
                                                   During the Coronavirus          title of the guidance in the
                                                   Disease 2019 (COVID-19)         request.
                                                   Public Health Emergency
                                                   (March 2020).
FDA-2020-D-1138........  CDRH...................  Enforcement Policy for          CDRH-Guidance@fda.hhs.gov
                                                   Sterilizers, Disinfectant       Please include the document
                                                   Devices, and Air Purifiers      number 20019 and complete
                                                   During the Coronavirus          title of the guidance in the
                                                   Disease 2019 (COVID-19)         request.
                                                   Public Health Emergency
                                                   (March 2020).
FDA-2020-D-1138........  CDRH...................  Enforcement Policy for Gowns,   CDRH-Guidance@fda.hhs.gov
                                                   Other Apparel, and Gloves       Please include the document
                                                   During the Coronavirus          number 20020 and complete
                                                   Disease (COVID-19) Public       title of the guidance in the
                                                   Health Emergency (March 2020).  request.
FDA-2020-D-1138........  CDRH...................  Enforcement Policy for Face     CDRH-Guidance@fda.hhs.gov.
                                                   Masks and Respirators During    Please include the document
                                                   the Coronavirus Disease         number 20018 and complete
                                                   (COVID-19) Public Health        title of the guidance in the
                                                   Emergency (Issued March 25,     request.
                                                   2020) (Revised April 2, 2020).
FDA-2020-D-1139........  Center for Food Safety   Temporary Policy Regarding      Office of Nutrition and Food
                          and Applied Nutrition    Nutrition Labeling of Certain   Labeling, Food Labeling and
                          (CFSAN).                 Packaged Food During the        Standards Staff, Center for
                                                   COVID-19 Public Health          Food Safety and Applied
                                                   Emergency (March 2020).         Nutrition, Food and Drug
                                                                                   Administration, 5001 Campus
                                                                                   Dr., College Park, MD 20740.
FDA-2020-D-1139........  CFSAN..................  Temporary Policy Regarding      Office of Nutrition and Food
                                                   Nutrition Labeling of           Labeling, Food Labeling and
                                                   Standard Menu Items in Chain    Standards Staff, Center for
                                                   Restaurants and Similar         Food Safety and Applied
                                                   Retail Food Establishments      Nutrition, Food and Drug
                                                   During the COVID-19 Public      Administration, 5001 Campus
                                                   Health Emergency (April 2020).  Dr., College Park, MD 20740.
FDA-2020-D-1139........  CFSAN..................  Temporary Policy Regarding      Office of Nutrition and Food
                                                   Packaging and Labeling of       Labeling, Food Labeling and
                                                   Shell Eggs Sold by Retail       Standards Staff, Center for
                                                   Food Establishments During      Food Safety and Applied
                                                   the COVID-19 Public Health      Nutrition, Food and Drug
                                                   Emergency (April 2020).         Administration, 5001 Campus
                                                                                   Dr., College Park, MD 20740.
FDA-2020-D-1106........  CDER...................  FDA Guidance on Conduct of      Clinicaltrialconduct-
                                                   Clinical Trials of Medical      [email protected] Please
                                                   Products during COVID-19        include the docket number FDA-
                                                   Public Health Emergency         2020-D-1106 and complete
                                                   (March 18, 2020) (Updated       title of the guidance in the
                                                   March 27, 2020, April 2,        request.
                                                   2020, and April 16, 2020).
FDA-2020-D-1106........  CDER...................  Temporary Policy for            druginfo@fda.hhs.gov. Please
                                                   Preparation of Certain          include the docket number FDA-
                                                   Alcohol-Based Hand Sanitizer    2020-D-1106 and complete
                                                   Products During the Public      title of the guidance in the
                                                   Health Emergency (COVID-19)     request.
                                                   (March 19, 2020) (Updated
                                                   March 27, 2020, and April 15,
                                                   2020).

[[Page 28013]]

 
FDA-2020-D-1106........  CDER...................  Policy for Certain REMS         druginfo@fda.hhs.gov. Please
                                                   Requirements During the COVID-  include the docket number FDA-
                                                   19 Public Health Emergency      2020-D-1106 and complete
                                                   (March 2020).                   title of the guidance in the
                                                                                   request.
FDA-2020-D-1106........  CDER...................  Temporary Policy for            druginfo@fda.hhs.gov. Please
                                                   Manufacture of Alcohol for      include the docket number FDA-
                                                   Incorporation Into Alcohol-     2020-D-1106 and complete
                                                   Based Hand Sanitizer Products   title of the guidance in the
                                                   During the Public Health        request.
                                                   Emergency (COVID-19) Guidance
                                                   for Industry (March 24, 2020)
                                                   (Updated March 27, 2020, and
                                                   April 15, 2020).
FDA-2020-D-1106........  CDER...................  Policy for Temporary            druginfo@fda.hhs.gov. Please
                                                   Compounding of Certain          include the docket number FDA-
                                                   Alcohol-Based Hand Sanitizer    2020-D-1106 and complete
                                                   Products During the Public      title of the guidance in the
                                                   Health Emergency (March 2020)   request.
                                                   (Updated April 15, 2020).
FDA-2020-D-1140........  Center for Veterinary    CVM GFI #269--Enforcement       AskCVM@fda.hhs.gov. Please
                          Medicine (CVM).          Policy Regarding Federal VCPR   include the docket number FDA-
                                                   Requirements to Facilitate      2020-D-1140 and complete
                                                   Veterinary Telemedicine         title of the guidance in the
                                                   During the COVID-19 Outbreak    request.
                                                   (March 2020).
FDA-2020-D-1140........  CVM....................  CVM GFI #270--Guidance on the   AskCVM@fda.hhs.gov.
                                                   Conduct and Review of Studies   Please include the docket
                                                   to Support New Animal Drug      number FDA-2020-D-1140 and
                                                   Development during the COVID-   complete title of the
                                                   19 Public Health Emergency      guidance in the request.
                                                   (April 2020).
----------------------------------------------------------------------------------------------------------------

    Although these guidance documents 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)).

III. Significance of Guidances

    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.

IV. Paperwork Reduction Act of 1995

A. Center for Biologics Evaluation and Research

    This guidance 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 
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:

----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title           21 CFR Cite referenced in    referenced in COVID-19      OMB Control
                                               COVID-19 guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Alternative Procedures for Blood and      601.12....................  N/A.......................       0910-0338
 Blood Components During the COVID-19     640.120...................                                   0910-0338
 Public Health Emergency.                 part 630..................                                   0910-0116
----------------------------------------------------------------------------------------------------------------

B. Center for Devices and Radiological Health

    These guidances 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:

----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title           21 CFR Cite referenced in    referenced in COVID-19      OMB Control
                                               COVID-19 Guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Non-Invasive       807, subpart E............  ..........................       0910-0120
 Remote Monitoring Devices Used to        800, 801, and 809.........                                   0910-0485
 Support Patient Monitoring During the
 Coronavirus Disease-2019 (COVID-19)
 Public Health Emergency.
Enforcement Policy for Ventilators and    800, 801, and 809.........                                   0910-0485
 Accessories and Other Respiratory        803.......................                                   0910-0437
 Devices During the Coronavirus Disease   807, subpart E............                                   0910-0120
 2019 (COVID-19) Public Health Emergency. 812.......................                                   0910-0078
                                          820.......................                                   0910-0073

[[Page 28014]]

 
                                                                      Emergency Use                    0910-0595
                                                                       Authorization of Medical
                                                                       Products and Related
                                                                       Authorities; Guidance for
                                                                       Industry and Other
                                                                       Stakeholders.
Enforcement Policy for Sterilizers,       800, 801, and 809.........                                   0910-0485
 Disinfectant Devices, and Air Purifiers  807, subpart E............                                   0910-0120
 During the Coronavirus Disease 2019      807, subparts A through D.                                   0910-0625
 (COVID-19) Public Health Emergency.
                                          814, subparts A through E.                                   0910-0231
                                          820.......................                                   0910-0073
                                          830 and 801.20............                                   0910-0720
Enforcement Policy for Gowns, Other       800, 801, and 809.........                                   0910-0485
 Apparel, and Gloves During the           806.......................                                   0910-0359
 Coronavirus Disease (COVID-19) Public    807, subparts A through D.                                   0910-0625
 Health Emergency.
                                          807, subpart E............                                   0910-0120
                                          820.......................                                   0910-0073
                                          830 and 801.20............                                   0910-0720
Enforcement Policy for Face Masks and     800, 801, and 809.........                                   0910-0485
 Respirators During the Coronavirus       803.......................                                   0910-0437
 Disease (COVID-19) Public Health         806.......................                                   0910-0359
 Emergency (Revised).                     807, subpart E............                                   0910-0120
                                          807, subparts A through D.                                   0910-0625
                                          820                                                          0910-0073
                                          830 and 801.20............                                   0910-0720
                                                                      Emergency Use                    0910-0595
                                                                       Authorization of Medical
                                                                       Products and Related
                                                                       Authorities; Guidance for
                                                                       Industry and Other
                                                                       Stakeholders.
----------------------------------------------------------------------------------------------------------------

C. Center for Food Safety and Applied Nutrition

    These guidances 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:

----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title           21 CFR Cite referenced in    referenced in COVID-19      OMB Control
                                               COVID-19 guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Nutrition      101.11....................  ..........................       0910-0782
 Labeling of Standard Menu Items in
 Chain Restaurants and Similar Retail
 Food Establishments During the COVID-19
 Public Health Emergency.
Temporary Policy Regarding Packaging and  part 101..................  Temporary Policy Regarding       0910-0381
 Labeling of Shell Eggs Sold by Retail                                 Nutrition Labeling of
 Food Establishments During the COVID-19                               Certain Packaged Food
 Public Health Emergency.                                              During the COVID19 Public
                                                                       Health Emergency; 0910-
                                                                       0381, 0910-0792.
----------------------------------------------------------------------------------------------------------------

    This guidance 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 
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.

[[Page 28015]]



----------------------------------------------------------------------------------------------------------------
                                  21 CFR Cite         Another guidance                         New collection
   COVID-19 guidance title       referenced in     referenced in COVID-19     OMB Control    covered by PHE PRA
                                   COVID-19               guidance              No(s).             waiver
-----------------------------------guidance---------------------------------------------------------------------
Temporary Policy Regarding     part 101;         .........................      0910-0381,  If a food product
 Nutrition Labeling of          section 403(w)                                   0910-0792   does not have the
 Certain Packaged Food During   of the FD&C Act                                              required labeling
 the COVID-19 Public Health     (21 U.S.C.                                                   information, a
 Emergency.                     343(w)).                                                     restaurant may
                                                                                             create a label to
                                                                                             include this
                                                                                             information (new
                                                                                             respondent).
----------------------------------------------------------------------------------------------------------------

D. Center for Drug Evaluation and Research

    This guidance 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 guidances have been approved by OMB as listed in the 
following table:

----------------------------------------------------------------------------------------------------------------
                                               21 CFR Cite
                                              referenced in     Another guidance referenced in      OMB Control
          COVID-19 guidance title               COVID-19              COVID-19 guidance               No(s).
                                                guidance
----------------------------------------------------------------------------------------------------------------
FDA Guidance on Conduct of Clinical Trials         50.27(a)  Use of Electronic Informed Consent        0910-0001
 of Medical Products during COVID-19 Public          312.30   in Clinical Investigations.              0910-0014
 Health Emergency (Updated).                         312.60                                            0910-0755
                                                     312.62
                                                  812.35(a)
                                                    812.140
----------------------------------------------------------------------------------------------------------------

    These guidances 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 
table below. These guidances also contain 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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        21 CFR Cite  referenced in   Another guidance referenced in COVID-    OMB Control     New collection covered by
       COVID-19 guidance title              COVID-19  guidance                   19  guidance                   No(s).             PHE PRA waiver
--------------------------------------------------------------------------------------------------------------------------------------------------------
Temporary Policy for Preparation of    ...........................  Policy for Temporary Compounding of          0910-0045  For proposed use of an
 Certain Alcohol-Based Hand Sanitizer                                Certain Alcohol-Based Hand Sanitizer        0910-0139   alternative grade of
 Products During the Public Health                                   Products During the Public Health           0910-0230   ethanol, firms are
 Emergency (COVID-19).                                               Emergency.                                  0910-0291   requested to submit to FDA
                                                                    Temporary Policy for Manufacture of          0910-0340   information on the ethanol
                                                                     Alcohol for Incorporation Into              0910-0641   concentration and levels of
                                                                     Alcohol-Based Hand Sanitizer Products       0910-0645   impurities listed in the
                                                                     During the Public Health Emergency          0910-0800   USP monograph and other
                                                                     (COVID-19).                                             potentially harmful
                                                                    Providing Regulatory Submissions in                      impurities in the
                                                                     Electronic Format--Drug Establishment                   manufacturing environment.
                                                                     Registration and Drug Listing.
                                                                    Postmarketing Adverse Event Reporting
                                                                     for Nonprescription Human Drug
                                                                     Products Marketed Without an Approved
                                                                     Application.

[[Page 28016]]

 
Policy for Temporary Compounding of    ...........................  Current Good Manufacturing Practices         0910-0139  For proposed use of an
 Certain Alcohol-Based Hand Sanitizer                                for Finished Pharmaceuticals and            0910-0230   alternative grade of
 Products During the Public Health                                   Medical Gases.                              0910-0291   ethanol, firms are
 Emergency (Updated).                                               Postmarketing Adverse Drug Experience        0910-0340   requested to submit to FDA
                                                                     Reporting.                                  0910-0645   information on the ethanol
                                                                    MedWatch: Adverse Event and Product                      concentration and levels of
                                                                     Experience Reporting System (Paper-                     impurities listed in the
                                                                     Based).                                                 USP monograph and other
                                                                    Format and Content Requirements for                      potentially harmful
                                                                     Over-the-Counter Drug Product                           impurities in the
                                                                     Labeling.                                               manufacturing environment.
                                                                    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).
Temporary Policy for Manufacture of    ...........................  Policy for Temporary Compounding of          0910-0045  For proposed use of an
 Alcohol for Incorporation Into                                      Certain Alcohol-Based Hand Sanitizer        0910-0139   alternative grade of
 Alcohol-Based Hand Sanitizer                                        Products During the Public Health           0910-0230   ethanol, firms are
 Products During the Public Health                                   Emergency.                                  0910-0291   requested to submit to FDA
 Emergency (COVID-19).                                              Temporary Policy for Preparation of          0910-0340   information on the ethanol
                                                                     Certain Alcohol-Based Hand Sanitizer        0910-0641   concentration and levels of
                                                                     Products During the Public Health           0910-0645   impurities listed in the
                                                                     Emergency (COVID-19).                                   USP monograph and other
                                                                    Providing Regulatory Submissions in                      potentially harmful
                                                                     Electronic Format--Drug Establishment                   impurities in the
                                                                     Registration and Drug Listing.                          manufacturing environment.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The final guidance entitled ``Policy for Certain REMS Requirements 
During the COVID-19 Public Health Emergency'' contains no collection of 
information. Therefore, clearance by OMB under the PRA is not required.

E. Center for Veterinary Medicine

    This guidance 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:

----------------------------------------------------------------------------------------------------------------
                                                                         Another guidance title
           COVID-19 guidance title              21 CFR Cite referenced   referenced in COVID-19     OMB Control
                                                 in COVID-19 guidance           guidance              No(s).
----------------------------------------------------------------------------------------------------------------
GFI #270--Guidance on the Conduct and Review   .......................  FDA Guidance on Conduct        0910-0032
 of Studies to Support New Animal Drug                                   of Clinical Trials of         0910-0669
 Development during the COVID-19 Public                                  Medical Products during
 Health Emergency.                                                       COVID-19 Public Health
                                                                         Emergency.
----------------------------------------------------------------------------------------------------------------

    The final guidance entitled ``GFI #269--Enforcement Policy 
Regarding Federal VCPR Requirements to Facilitate Veterinary 
Telemedicine During the COVID-19 Outbreak'' contains no collection of 
information. Therefore, clearance by OMB under the PRA is not required.

V. Electronic Access

    Persons with access to the internet may obtain COVID-19-related 
guidances at the FDA web page ``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 ``Search for FDA Guidance Documents,'' available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or https://www.regulations.gov.

    Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10146 Filed 5-11-20; 8:45 am]
BILLING CODE 4164-01-P


