[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38372-38378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13829]


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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-1138, FDA-
2020-D-1139, FDA-2020-D-1140]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of FDA guidance documents related to the Coronavirus 
Disease 2019 (COVID-19) public health emergency (PHE). This notice of 
availability (NOA) is pursuant to the process that FDA announced, in 
the Federal Register of March 25, 2020, for making available to the 
public COVID-19-related guidances. The guidances identified in this 
notice address issues related to the COVID-19 PHE and have been issued 
in accordance with the process announced in the March 25, 2020, notice. 
The 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 June 26, 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

[[Page 38373]]

comment does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the name of the 
guidance document that the comments address and the docket number for 
the guidance (see table 1). Received comments will be placed in the 
docket(s) and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of these guidances to the 
addresses noted in table 1. Send two self-addressed adhesive labels to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance documents.

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; 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 (42 U.S.C. 
247d) (PHS Act), determined that a PHE exists and has existed since 
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J. 
Trump declared that the COVID-19 outbreak in the United States 
constitutes a national emergency, beginning March 1, 2020.\2\
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    \1\ On April 21, 2020, the PHE Determination was extended, 
effective April 26, 2020. These PHE Determinations are available at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning 
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), 
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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    In the Federal Register of March 25, 2020 (the March 25, 2020, 
notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available 
FDA 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 entitled 
``COVID-19-Related Guidance Documents for Industry, FDA Staff, and 
Other Stakeholders'' (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled 
``Search for FDA Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The March 25, 2020, notice further stated that, in general, rather 
than publishing a separate NOA for each COVID-19-related guidance 
document, FDA intends to publish periodically a consolidated NOA 
announcing the availability of certain COVID-19-related guidance 
documents FDA issued during the relevant period, as included in table 
1. This notice announces COVID-19-

[[Page 38374]]

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:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                         Contact information to
             Docket No.                       Center              Title of guidance       request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1138.....................  CDRH..................  Notifying CDRH of         CDRH-
                                                               Permanent                 [email protected].
                                                               Discontinuance or         Please include the
                                                               Interruption in           document number 20032
                                                               Manufacturing of a        and complete title of
                                                               Device Under Section      the guidance in the
                                                               506J of the FD&C Act      request.
                                                               During the COVID-19
                                                               Public Health Emergency
                                                               (May 6, 2020).
FDA-2020-D-1138.....................  CDRH..................  Supplements for Approved  CDRH-
                                                               Premarket Approval        [email protected].
                                                               (PMA) or Humanitarian     Please include the
                                                               Device Exemption (HDE)    document number 20028
                                                               Submissions During the    and complete title of
                                                               Coronavirus Disease       the guidance in the
                                                               2019 (COVID-19) Public    request.
                                                               Health Emergency (May
                                                               21, 2020).
FDA-2020-D-1138.....................  CDRH..................  Enforcement Policy for    CDRH-
                                                               Face Masks and            [email protected].
                                                               Respirators During the    Please include the
                                                               Coronavirus Disease       document number 20018
                                                               (COVID-19) Public         and complete title of
                                                               Health Emergency (April   the guidance in the
                                                               2020) (Updated May 26,    request.
                                                               2020).
FDA-2020-D-1138.....................  CDRH..................  Recommendations for       CDRH-
                                                               Sponsors Requesting       [email protected].
                                                               EUAs for                  Please include the
                                                               Decontamination and       document number 20033
                                                               Bioburden Reduction       and complete title of
                                                               Systems for Face Masks    the guidance in the
                                                               and Respirators During    request.
                                                               the Coronavirus Disease
                                                               (COVID-19) Public
                                                               Health Emergency (May
                                                               26, 2020).
FDA-2020-D-1136.....................  CDER..................  Exemption and Exclusion   [email protected].
                                                               of Certain Requirements   Please include the
                                                               of the Drug Supply        docket number FDA-2020-
                                                               Chain Security Act        D-1136 and complete
                                                               During the COVID-19       title of the guidance
                                                               Public Health Emergency   in the request.
                                                               (April 30, 2020).
FDA-2020-D-1136.....................  CDER..................  COVID-19 Public Health    [email protected].
                                                               Emergency: General        Please include the
                                                               Considerations for Pre-   docket number FDA-2020-
                                                               IND Meeting               D-1136 and complete
                                                               Requirements for COVID-   title of the guidance
                                                               19 Related Drugs and      in the request.
                                                               Biological Products
                                                               (May 11, 2020).
FDA-2020-D-1136.....................  CDER..................  Temporary Policy          [email protected].
                                                               Regarding Non-Standard    Please include the
                                                               PPE Practices for         docket number FDA-2020-
                                                               Sterile Compounding by    D-1136 and complete
                                                               Pharmacy Compounders      title of the guidance
                                                               not Registered as         in the request.
                                                               Outsourcing Facilities
                                                               During the COVID-19
                                                               Public Health Emergency
                                                               (April 10, 2020)
                                                               (Updated May 14, 2020).
FDA-2020-D-1136.....................  CDER..................  Temporary Policy for      [email protected].
                                                               Compounding of Certain    Please include the
                                                               Drugs for Hospitalized    docket number FDA-2020-
                                                               Patients by Outsourcing   D-1136 and complete
                                                               Facilities During the     title of the guidance
                                                               COVID-19 Public Health    in the request.
                                                               Emergency (April 2020)
                                                               (Updated May 21, 2020).
FDA-2020-D-1136.....................  CDER..................  Temporary Policy for      [email protected].
                                                               Compounding of Certain    Please include the
                                                               Drugs for Hospitalized    docket number FDA-2020-
                                                               Patients by Pharmacy      D-1136 and complete
                                                               Compounders not           title of the guidance
                                                               Registered as             in the request.
                                                               Outsourcing Facilities
                                                               During the COVID-19
                                                               Public Health Emergency
                                                               (April 2020) (Updated
                                                               May 21, 2020).
FDA-2020-D-1136.....................  CDER..................  Effects of the COVID-19   [email protected].
                                                               Public Health Emergency   Please include the
                                                               on Formal Meetings and    docket number FDA-2020-
                                                               User Fee Applications--   D-1136 and complete
                                                               Questions and Answers     title of the guidance
                                                               (May 26, 2020).           in the request.
FDA-2020-D-1106.....................  CDER..................  FDA Guidance on Conduct   clinicaltrialconduct-
                                                               of Clinical Trials of     [email protected].
                                                               Medical Products during   Please include the
                                                               COVID-19 Public Health    docket number FDA-2020-
                                                               Emergency (March 2020)    D-1106 and complete
                                                               (Updated May 14 and       title of the guidance
                                                               June 3, 2020).            in the request.
FDA-2020-D-1139.....................  CFSAN.................  Returning Refrigerated    Retail Food Protection
                                                               Transport Vehicles and    Staff, Office of Food
                                                               Refrigerated Storage      Safety, Center for Food
                                                               Units to Food Uses        Safety and Applied
                                                               After Using Them to       Nutrition, Food and
                                                               Preserve Human Remains    Drug Administration,
                                                               During the COVID-19       5001 Campus Dr.,
                                                               Pandemic (May 12, 2020).  College Park, MD 20740.
FDA-2020-D-1139.....................  CFSAN.................  Temporary Policy          Office of Nutrition and
                                                               Regarding Certain Food    Food Labeling, Food
                                                               Labeling Requirements     Labeling and Standards
                                                               During the COVID-19       Staff, Center for Food
                                                               Public Health             Safety and Applied
                                                               Emergency: Minor          Nutrition, Food and
                                                               Formulation Changes and   Drug Administration,
                                                               Vending Machines (May     5001 Campus Dr.,
                                                               22, 2020).                College Park, MD 20740.
FDA-2020-D-1140.....................  CVM...................  GFI# 271 Reporting and    [email protected].
                                                               Mitigating Animal Drug    Please include the
                                                               Shortages during the      docket number FDA-2020-
                                                               COVID-19 Public Health    N-1140 and complete
                                                               Emergency (May 7, 2020).  title of the guidance
                                                                                         in the request.
----------------------------------------------------------------------------------------------------------------

    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

[[Page 38375]]

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. 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 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:

                                     Table 2--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                         Another guidance title
          COVID-19 guidance title              CFR cite referenced in    referenced in COVID-19     OMB control
                                                 COVID-19 guidance              guidance              No(s).
----------------------------------------------------------------------------------------------------------------
Supplements for Approved Premarket Approval  21 CFR part 814, subparts                                 0910-0231
 (PMA) or Humanitarian Device Exemption       A through E.                                             0910-0332
 (HDE) Submissions During the Coronavirus    21 CFR part 814, subpart                                  0910-0073
 Disease 2019 (COVID-19) Public Health        H.
 Emergency.                                  21 CFR part 820..........
                                             21 CFR parts 800, 801,     ........................       0910-0485
                                              and 809.
Recommendations for Sponsors Requesting      21 CFR part 803..........  ........................       0910-0437
 EUAs for Decontamination and Bioburden                                 Emergency Use                  0910-0595
 Reduction Systems for Face Masks and                                    Authorization of
 Respirators During the Coronavirus Disease                              Medical Products and
 2019 (COVID-19) Public Health Emergency.                                Related Authorities.
Enforcement Policy for Face Masks and        21 CFR parts 800, 801,     ........................       0910-0485
 Respirators During the Coronavirus Disease   and 809.                  ........................  ..............
 (COVID-19) Public Health Emergency.         21 CFR part 803..........  ........................       0910-0437
                                             21 CFR part 806..........  ........................       0910-0359
                                             21 CFR part 807, subpart   ........................       0910-0120
                                              E.
                                             21 CFR part 807, subparts  ........................       0910-0625
                                              A through D.
                                             21 CFR part 820..........  ........................       0910-0073
                                             21 CFR part 830 and        ........................       0910-0720
                                              801.20.
                                                                        Emergency Use                  0910-0595
                                                                         Authorization of
                                                                         Medical Products and
                                                                         Related Authorities.
----------------------------------------------------------------------------------------------------------------

    The guidance indicated in the table below refers to previously 
approved collections of information. These collections of information 
are subject to review by OMB under the PRA. The collections of 
information in the following FDA regulations and guidance have been 
approved by OMB as listed in the 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.

                                     Table 3--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance
   COVID-19 guidance     CFR cite referenced   referenced in COVID-  OMB control   New collection covered by PHE
         title           in COVID-19 guidance       19 guidance         No(s).              PRA waiver
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of       21 CFR part 807,                               0910-0625
 Permanent               subparts A through D. ....................  ...........
 Discontinuance or                             Emergency Use           0910-0595
 Interruption in                                Authorization of
 Manufacturing of a                             Medical Products
 Device Under Section                           and Related
 506J of the FD&C Act                           Authorities;
 During the COVID-19                            Guidance for
 Public Health                                  Industry and Other
 Emergency.                                     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 PHE.
                                                                                  Updates to FDA every 2 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
                                                                                   PHE.
----------------------------------------------------------------------------------------------------------------


[[Page 38376]]

B. 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 OMB under the PRA. The collections of 
information in the following FDA regulations and guidances have been 
approved by OMB as listed in the following table:

                                     Table 4--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
Effects of the COVID-19 Public Health   Sec.   10.115(g)(2)......  Planning for the Effects of         0910-0001
 Emergency on Formal Meetings and User                              High Absenteeism to Ensure         0910-0014
 Fee Applications..                                                 Availability of Medically          0910-0429
                                                                    Necessary Drug Products.           0910-0693
                                                                   Formal Meetings Between the         0910-0718
                                                                    FDA and Sponsors or                0910-0719
                                                                    Applicants of PDUFA Products.      0910-0727
                                                                   Formal Meetings Between the
                                                                    FDA and Sponsors or
                                                                    Applicants of BsUFA Products.
Exemption and Exclusion of Certain      .........................  Drug Supply Chain Security          0910-0777
 Requirements of the Drug Supply Chain                              Act Implementation:                0910-0800
 Security Act During the COVID-19                                   Identification of Suspect          0910-0806
 Public Health Emergency..                                          Product and Notification.          0910-0827
                                                                   Verification Systems Under          0910-0859
                                                                    the Drug Supply Chain
                                                                    Security Act for Certain
                                                                    Prescription Drugs.
                                                                   Definitions of Suspect
                                                                    Product and Illegitimate
                                                                    Product for Verification
                                                                    Obligations Under the Drug
                                                                    Supply Chain Security Act.
General Considerations for Pre-IND      21 CFR part 312..........  COVID-19: Developing Drugs          0910-0001
 Meeting Requirements for COVID-19                                  and Biological Products for        0910-0014
 Related Drugs and Biological                                       Treatment or Prevention.           0910-0338
 Products..                                                        Formal Meetings Between the         0910-0429
                                                                    FDA and Sponsors or                0910-0595
                                                                    Applicants of PDUFA Products.      0910-0719
                                                                   Emergency Use Authorization
                                                                    of Medical Products and
                                                                    Related Authorities.
                                                                   Preclinical Assessment of           0910-0814
                                                                    Investigational Cellular and
                                                                    Gene Therapy Products.
                                                                   Guidance for Clinical Trial
                                                                    Sponsors: Establishment and
                                                                    Operation of Clinical Trial
                                                                    Data Monitoring Committees.
                                                                   Use of Liquids and/or Soft
                                                                    Foods as Vehicles for Drug
                                                                    Administration: General
                                                                    Considerations for Selection
                                                                    and In Vitro Methods for
                                                                    Product Quality Assessments.
                                                                   Demonstrating Substantial
                                                                    Evidence of Effectiveness
                                                                    for Human Drug and
                                                                    Biological Products.
----------------------------------------------------------------------------------------------------------------

    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 guidances have been 
approved by OMB as listed in the below table. These guidances also 
contain new collections of information not approved under a current 
collection. These new collections of information have been granted a 
PHE waiver from the PRA by HHS on March 19, 2020, under section 319(f) 
of the PHS Act. Information concerning the PHE PRA waiver can be found 
on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                    Table 5-- CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance                              New collection
   COVID-19 guidance     CFR cite referenced   referenced in COVID-   OMB control No(s).     covered by PHE PRA
         title          in COVID-19 guidance       19 guidance                                     waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy for    21 CFR 314.81, 21     Current Good           0910-0777, 0910-      To provide
 Compounding of          CFR 600.82.           Manufacturing          0338, 0910-0001,      suitability and
 Certain Drugs for                             Practice--Guidance     0910-0139.            proof of sterility
 Hospitalized Patients                         for Human Drug                               for the container
 by Outsourcing                                Compounding                                  closure systems
 Facilities During the                         Outsourcing                                  used.
 COVID-19 Public                               Facilities Under
 Health Emergency.                             Section 503B of the
                                               FD&C Act.
Temporary Policy for    ....................  Compounded Drug        0910-0001, 0910-      For reporting of
 Compounding of                                Products That are      0139, 0910-0338.      adverse events by
 Certain Drugs for                             Essentially Copies                           pharmacy compounders
 Hospitalized Patients                         of a Commercially                            to the MedWatch
 by Pharmacy                                   Available Drug                               system and
 Compounders not                               Product under                                maintaining records
 Registered as                                 Section 503A of the                          of drugs suppliers
 Outsourcing                                   Federal Food, Drug,                          and patients who
 Facilities During the                         and Cosmetic Act.                            receive the
 COVID-19 Public                              Temporary Policy for                          compounded products.
 Health Emergency.                             Compounding of
                                               Certain Drugs for
                                               Hospitalized
                                               Patients by
                                               Outsourcing
                                               Facilities During
                                               the COVID-19 Public
                                               Health Emergency.
                                              Prescription
                                               Requirement Under
                                               Section 503A of the
                                               Federal Food, Drug,
                                               and Cosmetic Act.

[[Page 38377]]

 
                                              Temporary Policy
                                               Regarding Non-
                                               Standard PPE
                                               Practices for
                                               Sterile Compounding
                                               by Pharmacy
                                               Compounders not
                                               Registered as
                                               Outsourcing
                                               Facilities during
                                               the COVID-19 Public
                                               Health Emergency.
Temporary Policy        21 CFR parts 210 and  Enforcement Policy     0910-0139...........  Recordkeeping of
 Regarding Non-          211.                  for Face Masks and                           compounding
 Standard PPE                                  Respirators During                           performed without
 Practices for Sterile                         the Coronavirus                              standard PPE;
 Compounding by                                Disease (COVID-19)                           recordkeeping of any
 Pharmacy Compounders                          Public Health                                change of
 not Registered as                             Emergency (Revised).                         sterilization/
 Outsourcing                                  Enforcement Policy                            aseptic processing
 Facilities During the                         for Gowns, Other                             methods;
 COVID-19 Public                               Apparel, and Gloves                          documentation of
 Health Emergency.                             During the                                   mitigation
                                               Coronavirus Disease                          strategies for
                                               (COVID-19) Public                            sterile compounding
                                               Health Emergency.                            without standard
                                                                                            PPE.
                                              Electronic Drug
                                               Product Reporting
                                               for Human Drug
                                               Compounding
                                               Outsourcing
                                               Facilities Under
                                               Section 503B of the
                                               Federal Food, Drug,
                                               and Cosmetic Act.
Guidance on Conduct of  21 CFR part 11, 21    Formal Meetings        0910-0001, 0910-      Submission by
 Clinical Trials of      CFR part 50, 21 CFR   Between the FDA and    0014, 0910-0130,      investigators of
 Medical Products        part 56, 21 CFR       Sponsors or            0910-0303, 0910-      informed consent
 during COVID-19         part 312, 21 CFR      Applicants of PDUFA    0338, 0910-0119,      forms to third
 Public Health           part 314, 21 CFR      Products.              0910-0581, 0910-      parties.
 Emergency.              part 601, 21 CFR     Formal Meetings         0733, 0910-0078.
                         part 812.             Between the FDA and
                                               Sponsors or
                                               Applicants of BsUFA
                                               Products.
                                              Pediatric Study
                                               Plans: Content of
                                               and Process for
                                               Submitting Initial
                                               Pediatric Study
                                               Plans and Amended
                                               Pediatric Study
                                               Plans.
                                              Draft Guidance for
                                               Industry on
                                               Demonstrating
                                               Substantial Evidence
                                               of Effectiveness for
                                               Human Drug and
                                               Biological Products.
                                              Enhancing the
                                               Diversity of
                                               Clinical Trial
                                               Populations--Eligibi
                                               lity Criteria,
                                               Enrollment
                                               Practices, and Trial
                                               Design.
                                              Pregnant Women:
                                               Scientific and
                                               Ethical
                                               Considerations for
                                               Inclusion in
                                               Clinical Trials.
                                              Part 11, Electronic
                                               Records; Electronic
                                               Signatures Scope and
                                               Application.
                                              Use of Electronic
                                               Records and
                                               Electronic
                                               Signatures in
                                               Clinical
                                               Investigations under
                                               21 CFR Part 11--
                                               Questions and
                                               Answers.
                                              Safety Reporting
                                               Requirements for
                                               INDs and BA/BE
                                               Studies.
                                              Adverse Event
                                               Reporting to IRBs--
                                               Improving Human
                                               Subject Protection.
                                              Use of Electronic
                                               Informed Consent In
                                               Clinical
                                               Investigations.
                                              E6(R2) Good Clinical
                                               Practice: Integrated
                                               Addendum to ICH
                                               E6(R1).
                                              Providing Regulatory
                                               Submissions in
                                               Electronic Format--
                                               Certain Human
                                               Pharmaceutical
                                               Product Applications
                                               and Related
                                               Submissions Using
                                               the eCTD
                                               Specifications.
                                              Best Practices for
                                               Communication
                                               Between IND Sponsors
                                               and FDA During Drug
                                               Development.

[[Page 38378]]

 
                                              Requests for Feedback
                                               and Meetings for
                                               Medical Device
                                               Submissions: The Q-
                                               Submission Program.
----------------------------------------------------------------------------------------------------------------

C. CFSAN Guidance

    The guidance indicated in the table below refers to previously 
approved collections of information. These collections of information 
are subject to review by OMB under the PRA. The collections of 
information in the following FDA regulations and guidance have been 
approved by OMB as listed in the 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 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 Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance                              New collection
   COVID-19 guidance     CFR cite referenced   referenced in COVID-   OMB control No(s).     covered by PHE PRA
         title           in COVID-19 guidance       19 guidance                                    waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy        21 CFR part 101;       ....................  0910-0381, 0910-      Recommend that
 Regarding Certain       section 403(w) of                            0782, 0910-0792.      manufacturers post
 Mandatory Food          the FD&C Act.                                                      ingredient omissions
 Labeling Requirements                                                                      or substitutions not
 During the COVID-19                                                                        reflected on the
 Public Health                                                                              product label.
 Emergency: Minor
 Formulation Changes
 and Vending Machines.
----------------------------------------------------------------------------------------------------------------

    The guidance entitled ``Returning Refrigerated Transport Vehicles 
and Refrigerated Storage Units to Food Uses After Using Them to 
Preserve Human Remains During the COVID-19 Pandemic'' contains no 
collection of information. Therefore, clearance by OMB under the PRA is 
not required.

D. CVM Guidance

    This guidance indicated in the table below refers to previously 
approved collections of information. These collections of information 
are subject to review by OMB under the PRA. The collections of 
information in the following FDA regulations and guidance have been 
approved by OMB as indicated 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 7--CVM Guidance and Collection
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance                              New collection
   COVID-19 guidance     CFR cite referenced   referenced in COVID-   OMB control No(s).     covered by PHE PRA
         title           in COVID-19 guidance       19 guidance                                    waiver
----------------------------------------------------------------------------------------------------------------
GFI# 271, Reporting     21 CFR 514.1(a)).....  ....................  0910-0032, 0910-0669  Reporting and
 and Mitigating Animal                                                                      mitigating animal
 Drug Shortages during                                                                      drug shortages.
 the COVID-19 Public
 Health Emergency.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related 
guidances at:
     The FDA web page entitled ``COVID-19-Related Guidance 
Documents for Industry, FDA Staff, and Other Stakeholders,'' available 
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     the FDA web page entitled ``Search for FDA Guidance 
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13829 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P