[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46641-46646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1137, FDA-
2020-D-1138, FDA-2020-D-1139, and FDA-2020-D-1140]


Guidance Documents Related to Coronavirus Disease 2019; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of FDA guidance documents related to the Coronavirus 
Disease 2019 (COVID-19) public health emergency (PHE). This notice of 
availability (NOA) is pursuant to the process that FDA announced, in 
the Federal Register of March 25, 2020, for making available to the 
public COVID-19-related guidances. The guidances identified in this 
notice address issues related to the COVID-19 PHE and have been issued 
in accordance with the process announced in the March 25, 2020, notice. 
The 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 August 3, 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:

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

[[Page 46642]]

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 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: Stephen Ripley, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 
402-7911; Kimberly Thomas, Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357; 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; 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; Diane Heinz, 
Center for Veterinary Medicine (CVM), Food and Drug Administration, 
MPN2 RME435 HFV-6, 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, 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 (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 21 CFR 10.115(g)(2) (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 guidance 
documents that FDA issued during the relevant period, as included in 
Table 1. This notice announces COVID-19-related guidances that are 
posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice, 
FDA is announcing the availability of the following COVID-19-related 
guidance documents:

[[Page 46643]]



                        Table 1--Guidance Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                         Contact information to
            Docket No.                      Center              Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1106...................  CDER.................  Temporary Policy for        [email protected].
                                                            Preparation 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 (COVID-19)        request.
                                                            (March 2020) (Updated
                                                            June 1, 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 June 1, 2020).
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
                                                            June 1, 2020).
FDA-2020-D-1136...................  CDER.................  Temporary Policy on         [email protected].
                                                            Prescription Drug           Please include the
                                                            Marketing Act               docket number FDA-2020-D-
                                                            Requirements for            1136 and complete title
                                                            Distribution of Drug        of the guidance in the
                                                            Samples During the COVID-   request.
                                                            19 Public Health
                                                            Emergency (June 8, 2020).
FDA-2020-D-1136...................  CDER.................  Statistical Considerations  [email protected].
                                    CBER, CDRH, CVM......   for Clinical Trials         Please include the
                                                            During the COVID-19         docket number FDA-2020-D-
                                                            Public Health Emergency     1136 and complete title
                                                            Guidance for Industry       of the guidance in the
                                                            (June 2020).                request.
FDA-2020-D-1136...................  CDER, CVM, CBER......  Good Manufacturing          [email protected].
                                                            Practice Considerations     Please include the
                                                            for Responding to COVID-    docket number FDA-2020-D-
                                                            19 Infection in Employees   1136 and complete title
                                                            in Drug and Biological      of the guidance in the
                                                            Products Manufacturing      request.
                                                            (June 2020).
FDA-2020-D-1137...................  CBER.................  Development and Licensure   Office of Communication,
                                                            of Vaccines to Prevent      Outreach and
                                                            COVID-19 (June 2020).       Development, 10903 New
                                                                                        Hampshire Ave., Bldg.
                                                                                        71, Rm. 3128, Silver
                                                                                        Spring, MD 20993-0002.
                                                                                        Phone 1-800-835-4709 or
                                                                                        240-402-8010, email
                                                                                        [email protected].
FDA-2020-D-1138...................  CDRH.................  Enforcement Policy for Non- CDRH-
                                                            Invasive Remote             [email protected].
                                                            Monitoring Devices Used     Please include the
                                                            to Support Patient          document number 20014
                                                            Monitoring During the       and complete title of
                                                            Coronavirus Disease 2019    the guidance in the
                                                            (COVID-19) Public Health    request.
                                                            Emergency (Revised)
                                                            (March 20, 2020) (Updated
                                                            June 5, 2020).
FDA-2020-D-1138...................  CDRH.................  Notifying CDRH of a         CDRH-
                                                            Permanent Discontinuance    [email protected].
                                                            or Interruption in          Please include the
                                                            Manufacturing of a Device   document number 20032
                                                            Under Section 506J of the   and complete title of
                                                            FD&C Act During the COVID-  the guidance in the
                                                            19 Public Health            request.
                                                            Emergency (May 6, 2020)
                                                            (Updated June 19, 2020).
FDA-2020-D-1138...................  CDRH, CBER...........  Effects of the COVID-19     CDRH-
                                                            Public Health Emergency     [email protected].
                                                            on Formal Meetings and      Please include the
                                                            User Fee Applications for   document number 20040
                                                            Medical Devices--           and complete title of
                                                            Questions and Answers       the guidance in the
                                                            (June 2020).                request.
FDA-2020-D-1139...................  CFSAN................  Reporting a Temporary       INFOCenter-
                                                            Closure or Significantly    [email protected].
                                                            Reduced Production by a     Please include the
                                                            Human Food Establishment    docket number, FDA-2020-
                                                            and Requesting FDA          D-1139, and complete
                                                            Assistance During the       title of the guidance in
                                                            COVID-19 Public Health      the request.
                                                            Emergency (May 27, 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)).
    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 
guidance have been approved by OMB as listed in the following table:

[[Page 46644]]



                                     Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                 Another guidance
      COVID-19 guidance title         CFR cite referenced     referenced in COVID-19       OMB Control No(s).
                                      in COVID-19 guidance           guidance
----------------------------------------------------------------------------------------------------------------
Good Manufacturing Practice          21 CFR 211, 211.22,    (1) ICH Q7 Good             0910-0130
 Considerations for Responding to     211.28(d), 211.100.    Manufacturing Practice     0910-0139
 COVID-19 Infections in Employees    21 CFR 212.20,          Guidance for Active        0910-0667
 in Drug and Biological Products      212.30, 212.50,        Pharmaceutical             0910-0675
 Manufacturing--June 2020.            212.70, 212.71.        Ingredients.               0910-0759
                                     21 CFR 600.10(c)(1)..  (2) ICH Q5A Viral Safety    0910-0032
                                                             Evaluation of              0910-0669
                                                             biotechnology Products
                                                             Derived From Cell Lines
                                                             of Human or Animal Origin.
                                                            (3) ICH Q9 Quality Risk
                                                             Management.
                                                            (4) Planning for the
                                                             Effects of High
                                                             Absenteeism to Ensure
                                                             Availability of Medically
                                                             Necessary Drug Products.
                                                            (5) Enforcement Policy for
                                                             Sterilizers, disinfectant
                                                             Devices, and Air
                                                             Purifiers During the
                                                             Coronavirus Disease 2019
                                                             (COVID-19) Public Health
                                                             Emergency..
                                                            (6) 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..
                                                            (7) GFI #271 Reporting and
                                                             Mitigating Animal Drug
                                                             Shortages during the
                                                             COVID-19 Public Health
                                                             Emergency..
Temporary Policy on Prescription     21 CFR 203...........  ..........................  0910-0435
 Drug Marketing Act Requirements
 for Distribution of Drug Samples
 during the COVID-19 Public Health
 Emergency--Guidance for Industry.
Temporary Policy for Preparation of  27 CFR Part 20 and 21  (1) Temporary Compounding   0910-0045
 Certain Alcohol-Based Hand                                  of Certain Alcohol-Based   0910-0139
 Sanitizer Products During the                               Hand Sanitizer Products    0910-0230
 Public Health Emergency (COVID-                             During the Public Health   0910-0291
 19)--UPDATE of guidance announced                           Emergency (COVID-19).      0910-0340
 in March 2020.                                             (2) Temporary Policy for    0910-0641
                                                             Manufacture of Alcohol     0910-0645
                                                             for Incorporation Into     0910-0800
                                                             Alcohol-Based Hand
                                                             Sanitizer Products During
                                                             the Public Health
                                                             Emergency (COVID-19).
                                                            (3) Adverse Event
                                                             Reporting Requirements.
Temporary Policy for Manufacture of  27 CFR Part 20 and 21  None......................  0910-0045
 Alcohol for Incorporation Into                                                         0910-0139
 Alcohol-Based Hand Sanitizer                                                           0910-0230
 Products During the Public Health                                                      0910-0291
 Emergency (COVID-19)--UPDATE of                                                        0910-0340
 guidance announced in March 2020.                                                      0910-0641
                                                                                        0910-0645
                                                                                        0910-0800
Policy for Temporary Compounding of  .....................  (1) Temporary Policy for    0910-0045
 Certain Alcohol-Based Hand                                  Preparation of Certain     0910-0139
 Sanitizer Products During the                               Alcohol-Based Hand         0910-0230
 Public Health Emergency                                     Sanitizer Products During  0910-0291
 Immediately in Effect Guidance for                          the Public Health          0910-0340
 Industry--UPDATE of guidance                                Emergency (COVID-19).      0910-0641
 announced in March 2020.                                   (2) Temporary Policy for    0910-0645
                                                             Manufacture of Alcohol     0910-0800
                                                             for Incorporation into
                                                             Alcohol-Based Hand
                                                             Sanitizer Products During
                                                             the Public Health
                                                             Emergency (COVID-19).
----------------------------------------------------------------------------------------------------------------

    The guidance, Statistical Considerations for Clinical Trials during 
the COVID-19 Public Health Emergency, contains no collection of 
information. Therefore, clearance by OMB under the PRA is not required.

B. CBER Guidances

    The guidance listed in the table below refer to previously approved 
collection of information. This collection of information is subject to 
review by the OMB under the PRA. The collection of information in the 
following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

[[Page 46645]]



                                     Table 3--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                               Another guidance title
       COVID-19 guidance title        CFR cite referenced  in   referenced  in COVID-      OMB Control No(s).
                                         COVID-19 guidance           19 guidance
----------------------------------------------------------------------------------------------------------------
Development and Licensure of          21 CFR part 312........  ......................  0910-0114
 Vaccines to Prevent COVID-19.        21 CFR part 58.........  ......................  0910-0119
                                      21 CFR part 50.........  ......................  0910-0130
                                      21 CFR parts 210, 211,   ......................  0910-0139
                                       and 610.
                                      221 CFR part 600.......  ......................  0910-0308
                                      221 CFR part 601.......  ......................  0910-0338
                                                               --Form FDA 3500A......  0910-0291
                                                               --Establishment and     0910-0581
                                                                Operation of Clinical  0910-0595
                                                                Trial Data Monitoring
                                                                Committees.
                                                               --Emergency Use
                                                                Authorization of
                                                                Medical Products and
                                                                Related Authorities.
----------------------------------------------------------------------------------------------------------------

C. CDRH Guidances

    The guidances listed in the table 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:

                                     Table 4--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                               Another guidance title
       COVID-19 guidance title        CFR cite referenced  in   referenced  in COVID-      OMB Control No(s).
                                         COVID-19 guidance           19 guidance
----------------------------------------------------------------------------------------------------------------
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
 (Revised) (March 20, 2020) (Updated
 June 5, 2020).
Effects of the COVID-19 Public        .......................  Requests for Feedback   0910-0756
 Health Emergency on Formal Meetings                            and Meetings for
 and User Fee Applications for                                  Medical Device
 Medical Devices--Questions and                                 Submissions: The Q-
 Answers (June 22, 2020).                                       Submission Program:
                                                                Guidance for Industry
                                                                and Food and Drug
                                                                Administration Staff.
                                                               Emergency Use           0910-0595
                                                                Authorization of
                                                                Medical Products and
                                                                Related Authorities;
                                                                Guidance for Industry
                                                                and Other
                                                                Stakeholders.
                                      814, subparts A through  ......................  0910-0231
                                       E.
                                      807, subpart E.........  ......................  0910-0120
                                                               De Novo Classification  0910-0844
                                                                Process (Evaluation
                                                                of Automatic Class
                                                                III Designation):
                                                                Guidance for Industry
                                                                and Food and Drug
                                                                Administration Staff.
                                      814, subpart H.........  ......................  0910-0332
                                      812....................  ......................  0910-0078
----------------------------------------------------------------------------------------------------------------

    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. 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 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.

[[Page 46646]]



                                     Table 5--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                      CFR cite        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
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of Permanent      807, subparts A                         0910-0625
 Discontinuance or Interruption   through D.         Emergency Use       0910-0595
 in Manufacturing of a Device                         Authorization of
 Under Section 506J of the FD&C                       Medical Products
 Act During the COVID-19 Public                       and Related
 Health Emergency (Revised)                           Authorities;
 (May 6, 2020) (Updated June                          Guidance for
 19, 2020).                                           Industry and
                                                      Other
                                                      Stakeholders.
                                                                                               Notifications to
                                                                                                FDA about
                                                                                                changes in the
                                                                                                production of
                                                                                                certain medical
                                                                                                device products
                                                                                                that will help
                                                                                                the Agency
                                                                                                prevent or
                                                                                                mitigate
                                                                                                shortages of
                                                                                                such devices
                                                                                                during the COVID-
                                                                                                19 public health
                                                                                                emergency.
                                                                                               Updates to FDA
                                                                                                every two weeks
                                                                                                after initial
                                                                                                notification on
                                                                                                the shortage
                                                                                                situation,
                                                                                                including the
                                                                                                expected
                                                                                                timeline for
                                                                                                recovery.
                                                                                               Voluntary
                                                                                                submission of
                                                                                                other
                                                                                                information that
                                                                                                enables FDA to
                                                                                                work more
                                                                                                effectively with
                                                                                                manufacturers
                                                                                                and other
                                                                                                entities to
                                                                                                prevent or limit
                                                                                                any negative
                                                                                                impact on
                                                                                                patients or
                                                                                                healthcare
                                                                                                providers during
                                                                                                the COVID-19
                                                                                                public health
                                                                                                emergency.
----------------------------------------------------------------------------------------------------------------

D. CFSAN 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. 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 6--CFSAN Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                      CFR cite        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
----------------------------------------------------------------------------------------------------------------
Reporting a Temporary Closure    21 CFR part 1,      ..................  0910-0502             Establishments
 or Significantly Reduced         subpart H.                                                    have the option
 Production by a Human Food                                                                     to report to FDA
 Establishment and Requesting                                                                   temporary
 FDA Assistance During the                                                                      closures or
 COVID-19 Public Health                                                                         significant
 Emergency.                                                                                     reductions of
                                                                                                production and
                                                                                                to request
                                                                                                assistance from
                                                                                                FDA.
----------------------------------------------------------------------------------------------------------------

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: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16852 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P