[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15417-15422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2007-D-0369, FDA-2008-D-0610, FDA-2015-D-1211, FDA-
2021-D-0409, FDA-2020-D-0987, FDA-2020-D-1057, FDA-2020-D-1106, FDA-
2020-D-1106-0002, FDA-2020-D-1108, FDA-2020-D-1136, FDA-2020-D-1137, 
FDA-2020-D-1138, FDA-2020-D-1139, FDA-2020-D-1140, FDA-2020-D-1304, 
FDA-2020-D-1370, FDA-2020-D-1386, FDA-2020-D-1414, FDA-2020-D-1824, 
FDA-2020-D-1825, FDA-2020-D-2016, FDA-2021-D-1311]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: On February 9, 2023, the Secretary of Health and Human 
Services (HHS) renewed the Coronavirus Disease 2019 (COVID-19) public 
health emergency declaration issued under section 319 of the Public 
Health Service Act (PHS Act) (``PHE declaration''), effective February 
11, 2023. The declaration is expected to expire at the end of the day 
on May 11, 2023. The Food and Drug Administration (FDA, Agency, or we) 
has issued guidance documents to address the circumstances of the 
public health emergency and, more generally, COVID-19. Many of those 
guidance documents are tied to the duration of the PHE declaration. 
This notice is intended to provide clarity to stakeholders with respect 
to the guidance documents that will no longer be effective with the 
expiration of the PHE declaration and the guidances that FDA is 
revising to continue in effect after the expiration of the PHE 
declaration.

FOR FURTHER INFORMATION CONTACT: Diane Maloney, 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; Erica Takai, Center for Devices and Radiological Health 
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353; Kimberly 
Thomas, Center for Drug Evaluation and Research, Food and Drug 
Administration (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, 
Silver Spring, MD 20993-0002, 301-796-2357; Philip 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, 7500 Standish Pl., HFV-6, Rockville, MD 20855, 240-402-
5692; Amanda Wulf, Office of Regulatory Affairs (ORA), Food and Drug 
Administration, 12420 Parklawn Dr., ELEM-4044, Rockville, MD 20857, 
301-796-8856.

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, the 
prior Secretary of HHS, pursuant to the authority under section 319 of 
the PHS Act (42 U.S.C. 247d), determined that a PHE existed (COVID-19 
PHE) and had existed since January 27, 2020, nationwide.\1\ On February 
9, 2023, the Secretary of HHS renewed the COVID-19 PHE declaration, 
effective February 11, 2023. On February 9, based on current COVID-19 
trends, HHS announced that it is planning for the declaration to expire 
at the end of the day on May 11, 2023. (HHS, Fact Sheet: COVID-19 
Public Health Emergency Transition Roadmap (February 9, 2023), 
available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-
covid-19-public-health-emergency-transition-
roadmap.html#:~:text=Based%20on%20current%20COVID%2D19,day%20on%20May%20
11%2C%202023).
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    \1\ Secretary of HHS, ``Determination that a Public Health 
Emergency Exists'' (originally issued on January 31, 2020, and 
subsequently renewed, pursuant to the authority under section 319 of 
the PHS Act), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. There are additional types of 
determinations and declarations related to emergencies, including 
public health emergencies, that are distinct from a PHE declared 
pursuant to section 319 of the PHS Act. For instance, the 
determination and declarations made under section 564 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), which enable the issuance 
of Emergency Use Authorizations (EUAs), are independent from a 
declaration under section 319 of the PHS Act.
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    Since the start of the COVID-19 pandemic in 2020, FDA has issued 
more than 80 COVID-19-related guidances (not including revisions). In 
the Federal Register of March 25, 2020 (85 FR 16949) (available at 
https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), 
FDA announced general procedures for making available FDA guidances 
related to the COVID-19 PHE. We have updated or otherwise modified our 
COVID-19-related guidances in response to comments received, as 
appropriate, and as relevant needs and circumstances evolved throughout 
the COVID-19 PHE. We have withdrawn, and announced the

[[Page 15418]]

withdrawal of, several COVID-19-related guidances after determining 
that the policies no longer represented the Agency's current 
thinking.\2\ In December 2021, we issued a draft guidance ``Transition 
Plan for Medical Devices That Fall Within Enforcement Policies Issued 
During the COVID-19 Public Health Emergency'' (``draft device 
enforcement policy transition guidance'') that describes FDA's proposed 
plans for devices that fall within the enforcement policies of certain 
device guidances issued during the COVID-19 PHE.\3\ FDA intends to 
finalize the draft guidance as soon as practicable. In the Federal 
Register of December 8, 2022 (87 FR 75275), FDA announced the 
availability of a final guidance ``Recommendations to Reduce the Risk 
of Transfusion-Transmitted Malaria,'' which replaced the COVID-19-
related guidance FDA issued in April 2020, and is available at https://www.fda.gov/media/163737/download.
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    \2\ See 86 FR 55620 (October 6, 2021), available at https://www.federalregister.gov/documents/2021/10/06/2021-21798/guidance-documents-related-to-coronavirus-disease-2019-availability; 86 FR 
56960 (October 13, 2021), available at https://www.federalregister.gov/documents/2021/10/13/2021-22108/alcohol-based-hand-sanitizer-products-withdrawal-of-three-temporary-guidance-documents-issued-during; 87 FR 34691 (June 7, 2022), 
available at https://www.federalregister.gov/documents/2022/06/07/2022-12176/effects-of-the-covid-19-public-health-emergency-on-formal-meetings-and-user-fee-applications-for; 87 FR 78111 (December 
21, 2022), available at https://www.federalregister.gov/documents/2022/12/21/2022-27673/enforcement-policy-regarding-federal-veterinarian-client-patient-relationship-requirements-to; 88 FR 8872 
(February 10, 2023), available at https://www.federalregister.gov/documents/2023/02/10/2023-02809/temporary-policy-on-repackaging-or-combining-propofol-drug-products-during-the-covid-19-public. In 
addition, one guidance document entitled ``Policy for Certain REMS 
Requirements During the Tocilizumab Shortage Related to the COVID-19 
Public Health Emergency'' stated it would ``remain in effect for the 
duration of the tocilizumab shortage''; because the tocilizumab 
shortage resolved on March 30, 2022, the guidance is no longer in 
effect (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/withdrawn-guidances-biologics).
    \3\ See 86 FR 72973 (December 23, 2021). Concurrent with 
issuance of the draft device enforcement policy transition guidance, 
FDA also issued ``Transition Plan for Medical Devices Issued 
Emergency Use Authorizations (EUAs) During the COVID-19 Public 
Health Emergency,'' which described and sought comment on FDA's 
general recommendations for a transition for devices issued EUAs. 
See 86 FR 72978 (December 23, 2021). FDA also intends to finalize 
this guidance as soon as practicable.
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    Circumstances have changed since 2020 when FDA first began issuing 
guidances to support COVID-19 response efforts. For example, several 
COVID-19 guidances were developed to help address supply chain 
disruptions. In several instances, supply chains have stabilized and 
the relevant COVID-19 guidances are no longer needed. Some COVID-19 
guidances were issued to clarify previously issued recommendations by 
tailoring them to specific considerations for the pandemic. Because 
these COVID-19 guidances will not be needed when the PHE declaration 
expires, FDA is not extending them. In other instances, the science 
behind certain recommendations has advanced, and FDA may want to update 
certain guidances to reflect new data.
    This notice addresses the 72 COVID-19-related guidance documents 
that are currently in effect and listed below. Most of these COVID-19-
related guidances state that they are intended to remain in effect only 
for the duration of the COVID-19 PHE declaration. In light of HHS's 
recent announcement that the PHE declaration is expected to expire on 
May 11, 2023, FDA has reviewed these COVID-19-related guidance 
documents and has examined whether any of the guidances should be 
continued past expiration of the PHE declaration--for example, to 
provide stakeholders including industry, healthcare providers, 
patients, consumers, and FDA time to transition from policies adopted 
and operations implemented during the COVID-19 PHE.
    Based on this review, in this notice, FDA is announcing that the 
COVID-19-related guidances listed in section II, table 1 will no longer 
be in effect when the PHE declaration expires. FDA also is announcing 
that the COVID-19-related guidance documents listed in section III, 
table 2 of this notice are being revised to continue in effect for 180 
days after the PHE declaration expires, then will no longer be in 
effect. The guidance documents listed in section IV, table 3 of this 
notice are being revised to continue in effect for 180 days after the 
PHE declaration expires, during which time FDA plans to further revise 
these guidances. Finally, this notice lists, in section V, table 4, 
COVID-19-related guidance documents whose intended duration is not tied 
to the COVID-19 PHE and that will remain in effect when the COVID-19 
PHE declaration expires.
    FDA's revision of the guidances in section III, table 2 and section 
IV, table 3 so that they continue in effect for a brief period after 
expiration of the PHE declaration constitutes a minor change under 21 
CFR 10.115(c)(2) and (g)(4). Even if these revisions were not minor 
changes, FDA has determined that obtaining comment prior to 
implementation is not feasible or appropriate, given the need for an 
orderly transition and given that the PHE declaration is anticipated to 
expire on May 11, 2023. Moreover, FDA already has solicited comments on 
these policies, through dockets for the guidances, and we have taken 
the comments received into account in issuing this notice. This period 
of time will provide an opportunity for stakeholders to transition from 
policies adopted and operations implemented during the COVID-19 PHE 
(see section III, table 2 below) or for FDA to further revise or 
otherwise update the guidance (see section IV, table 3 below). Although 
the changes to continue the guidances in section III, table 2 and 
section IV, table 3 for a brief period after the PHE declaration 
expires are being implemented immediately without prior comment, FDA 
will consider all comments received and revise the guidances as 
appropriate.
    As the COVID-19 pandemic evolves, FDA continues to assess the needs 
and circumstances related to the policies in our COVID-19-related 
guidances, and we may alter our approach for individual guidances 
listed in this notice. For instance, FDA could withdraw a guidance 
before the COVID-19 PHE declaration expires should reassessment show 
policy reflected in a particular guidance document is no longer needed. 
However, should FDA alter our approach for particular guidances, we 
will do so consistent with our good guidance practices regulation (21 
CFR 10.115).

II. COVID-19 Guidance Documents That Will No Longer Be in Effect Upon 
Expiration of the COVID-19 PHE Declaration

    FDA has identified 22 COVID-19-related guidances that should no 
longer be in effect upon expiration of the COVID-19 PHE declaration. 
Most of these guidances state that they are intended to remain in 
effect only for the duration of the declared COVID-19 PHE. FDA has 
assessed the needs and circumstances related to the policies 
articulated in the 22 guidances listed in table 1. FDA also has 
considered comments submitted to the dockets for these guidances, and 
our experience with implementation. Upon review, FDA continues to 
believe that it is appropriate for these guidances to end when the PHE 
declaration expires.
    While generally intended to be in effect for the duration of the 
COVID-19 PHE declaration, five guidances listed in table 1 also 
indicated that FDA expected their recommendations would continue to 
assist the Agency and/or stakeholders outside the expiration of the PHE 
declaration, otherwise reflected FDA's current thinking, or were 
proposed to be extended in the draft device enforcement policy 
transition guidance.

[[Page 15419]]

Upon assessment of these guidances, FDA has found that these will no 
longer be needed because the recommendations are described in other 
guidance documents or the conditions related to the COVID-19 PHE as 
outlined in the guidances have changed and stakeholders have resumed or 
adjusted operations and are no longer relying on the guidances. 
Therefore, FDA has concluded it is appropriate for these five 
guidances, marked with an asterisk in table 1, to end upon expiration 
of the PHE declaration.
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    \4\ While the guidance document entitled ``Exemption and 
Exclusion from Certain Requirements of the Drug Supply Chain 
Security Act During the COVID-19 Public Health Emergency'' will no 
longer be in effect when the COVID-19 PHE declared under section 319 
of the PHS Act expires, the Agency retains authority under section 
582(a) of the FD&C Act (21 U.S.C. 360eee-1(a)) to grant waivers, 
exemptions, and exceptions to allow for continued distribution of 
covered COVID-19 Drug Supply Chain Security Act products, as 
appropriate, which may be used to avoid disruption beyond the 
expiration of such declaration.

  Table 1--Guidance Documents That Will No Longer Be in Effect Upon Expiration of the COVID-19 PHE Declaration
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137............................  CBER......................  Manufacturing Considerations for
                                                                          Licensed and Investigational Cellular
                                                                          and Gene Therapy Products During COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1136............................  CDER......................  COVID-19 Public Health Emergency Policy
                                                                          on COVID-19-Related Sanitation
                                                                          Tunnels.
FDA-2021-D-1311............................  CDER......................  Nonclinical Considerations for
                                                                          Mitigating Nonhuman Primate Supply
                                                                          Constraints Arising from the COVID-19
                                                                          Pandemic.*
FDA-2020-D-1136............................  CDER......................  Development of Abbreviated New Drug
                                                                          Applications During the COVID-19
                                                                          Pandemic--Questions and Answers.
FDA-2020-D-1136............................  CDER......................  Protecting Participants in
                                                                          Bioequivalence Studies for Abbreviated
                                                                          New Drug Applications During the COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1136............................  CDER......................  Review Timelines for Applicant
                                                                          Responses to Complete Response Letters
                                                                          When a Facility Assessment Is Needed
                                                                          During the COVID-19 Public Health
                                                                          Emergency Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Resuming Normal Drug and Biologics
                                                                          Manufacturing Operations During the
                                                                          COVID-19 Public Health Emergency.*
FDA-2020-D-1136............................  CDER......................  Good Manufacturing Practice
                                                                          Considerations for Responding to COVID-
                                                                          19 Infection in Employees in Drug and
                                                                          Biological Products Manufacturing.*
FDA-2020-D-1136............................  CDER......................  Statistical Considerations for Clinical
                                                                          Trials During the COVID-19 Public
                                                                          Health Emergency.
FDA-2020-D-1136............................  CDER......................  Effects of the COVID-19 Public Health
                                                                          Emergency on Formal Meetings and User
                                                                          Fee Applications--Questions and
                                                                          Answers.
FDA-2020-D-1136............................  CDER......................  Temporary Policy for Compounding of
                                                                          Certain Drugs for Hospitalized
                                                                          Patients by Outsourcing Facilities
                                                                          During the COVID-19 Public Health
                                                                          Emergency.
FDA-2020-D-1136............................  CDER......................  Temporary Policy for Compounding of
                                                                          Certain Drugs for Hospitalized
                                                                          Patients by Pharmacy Compounders not
                                                                          Registered as Outsourcing Facilities
                                                                          During the COVID-19 Public Health
                                                                          Emergency Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  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.
FDA-2020-D-1136............................  CDER......................  Temporary Policy on Prescription Drug
                                                                          Marketing Act Requirements for
                                                                          Distribution of Drug Samples During
                                                                          the COVID-19 Public Health Emergency.*
FDA-2020-D-1136............................  CDER......................  COVID-19 Public Health Emergency:
                                                                          General Considerations for Pre-IND
                                                                          Meeting Requests for COVID-19 Related
                                                                          Drugs and Biological Products.
FDA-2020-D-1136............................  CDER......................  Exemption and Exclusion from Certain
                                                                          Requirements of the Drug Supply Chain
                                                                          Security Act During the COVID-19
                                                                          Public Health Emergency.\4\
FDA-2020-D-1138............................  CDRH......................  Notifying CDRH of a Permanent
                                                                          Discontinuance or Interruption in
                                                                          Manufacturing of a Device Under
                                                                          Section 506J of the FD&C Act During
                                                                          the COVID-19 Public Health Emergency
                                                                          (Revised).
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for the Quality
                                                                          Standards of the Mammography Quality
                                                                          Standards Act During the COVID-19
                                                                          Public Health Emergency.*
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Enforcement
                                                                          of 21 CFR Part 118 (the Egg Safety
                                                                          Rule) During the COVID-19 Public
                                                                          Health Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Packaging
                                                                          and Labeling of Shell Eggs Sold by
                                                                          Retail Food Establishments During the
                                                                          COVID-19 Public Health Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Nutrition
                                                                          Labeling of Certain Packaged Food
                                                                          During the COVID-19 Public Health
                                                                          Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Reporting a Temporary Closure or
                                                                          Significantly Reduced Production by a
                                                                          Human Food Establishment and
                                                                          Requesting FDA Assistance During the
                                                                          COVID-19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------

III. COVID-19 Guidance Documents That FDA Is Revising To Continue in 
Effect for 180 Days After the PHE Declaration Expires To Provide a 
Period for Stakeholder Transition

    Based on our review, FDA has identified 22 COVID-19-related 
guidances that, similar to the guidances previously discussed, can be 
discontinued in connection with expiration of the COVID-19 PHE 
declaration but for which an additional wind-down period is appropriate 
to allow for an orderly transition. In general, these guidances were 
intended to be in effect for the duration of the declared COVID-19 PHE. 
However, FDA has considered the circumstances surrounding the current 
phase of the COVID-19 pandemic, comments submitted to the dockets for 
these guidances, and our experience with implementation, and has 
determined that for these guidances, stakeholders such as industry, 
healthcare providers, patients, consumers, and FDA would benefit from 
additional time to

[[Page 15420]]

transition from the policies adopted during the COVID-19 PHE. Thus, FDA 
is revising the 22 guidances listed in table 2 to continue in effect 
for 180 days after the expiration of the PHE declaration--i.e., after 
November 7, 2023, they will no longer be in effect. We note that some 
of these guidances are addressed in the draft device enforcement policy 
transition guidance, which, when finalized, may specify a duration 
period for these guidances that is longer than the time period 
described here. Therefore, the guidances listed in table 2 are being 
revised to reflect that they continue in effect for 180 days after the 
COVID-19 PHE declaration expires, with the exception of guidances 
covered under the draft device enforcement policy transition guidance. 
Those device guidances, which are identified in table 2 with an 
asterisk, are being revised to reflect that they continue in effect for 
180 days after expiration of the PHE declaration unless a different 
intended duration for the guidance is set forth in the final device 
transition guidance.
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    \5\ FDA is revising the guidance ``Enforcement Policy for Face 
Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and 
Respirators During the Coronavirus Disease (COVID-19) Public Health 
Emergency (Revised)'' to split it into two separate guidance 
documents, each with identical policies to the corresponding parts 
of the September 2021 version. Concurrent with issuance of this 
guidance addressing face shields, surgical masks, and respirators, 
FDA also is issuing ``Enforcement Policy for Face Masks and Barrier 
Face Coverings During the Coronavirus Disease (COVID-19) Public 
Health Emergency.'' That guidance is listed in table 3 of this 
notice.

      Table 2--Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the COVID-19 PHE
                                               Declaration Expires
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1136............................  CDER......................  Policy for the Temporary Use of
                                                                          Portable Cryogenic Containers Not in
                                                                          Compliance With 21 CFR 211.94(e)(1)
                                                                          For Oxygen and Nitrogen During the
                                                                          COVID-19 Public Health Emergency
                                                                          Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Manufacturing, Supply Chain, and Drug
                                                                          and Biological Product Inspections
                                                                          During COVID-19 Public Health
                                                                          Emergency Questions and Answers.
FDA-2020-D-1106............................  CDER......................  Policy for Certain REMS Requirements
                                                                          During the COVID-19 Public Health
                                                                          Emergency Guidance for Industry and
                                                                          Health Care Professionals.
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Remote Digital
                                                                          Pathology Devices During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Imaging Systems
                                                                          During the Coronavirus Disease 2019
                                                                          (COVID-19) Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Non-Invasive
                                                                          Fetal and Maternal Monitoring Devices
                                                                          Used to Support Patient Monitoring
                                                                          During the Coronavirus Disease 2019
                                                                          (COVID-19) Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for
                                                                          Telethermographic Systems During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Digital Health
                                                                          Devices for Treating Psychiatric
                                                                          Disorders During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Extracorporeal
                                                                          Membrane Oxygenation and
                                                                          Cardiopulmonary Bypass Devices During
                                                                          the Coronavirus Disease 2019 (COVID-
                                                                          19) Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Remote
                                                                          Ophthalmic Assessment and Monitoring
                                                                          Devices During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Infusion Pumps
                                                                          and Accessories During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Face Shields,
                                                                          Surgical Masks, and Respirators During
                                                                          the Coronavirus Disease 2019 (COVID-
                                                                          19) Public Health Emergency.* \5\
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Gowns, Other
                                                                          Apparel, and Gloves During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Sterilizers,
                                                                          Disinfectant Devices, and Air
                                                                          Purifiers During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Ventilators and
                                                                          Accessories and Other Respiratory
                                                                          Devices During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Modifications to
                                                                          FDA Cleared Molecular Influenza and
                                                                          RSV Tests During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Coagulation Systems for Measurement of
                                                                          Viscoelastic Properties: Enforcement
                                                                          Policy During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency (Revised).*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Viral Transport
                                                                          Media During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency (Revised).*
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Nutrition
                                                                          Labeling of Standard Menu Items in
                                                                          Chain Restaurants and Similar Retail
                                                                          Food Establishments During the COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Certain Food
                                                                          Labeling Requirements During the COVID-
                                                                          19 Public Health Emergency: Minor
                                                                          Formulation Changes and Vending
                                                                          Machines.
FDA-2020-D-1386............................  CFSAN.....................  Temporary Policy During the COVID-19
                                                                          Public Health Emergency Regarding the
                                                                          Qualified Exemption from the Standards
                                                                          for the Growing, Harvesting, Packing,
                                                                          and Holding of Produce for Human
                                                                          Consumption.
FDA-2020-D-1140............................  CVM.......................  CVM GFI #270--Guidance on the Conduct
                                                                          and Review of Studies to Support New
                                                                          Animal Drug Development during the
                                                                          COVID-19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------


[[Page 15421]]

IV. COVID-19 Guidance Documents FDA Is Revising To Continue in Effect 
for 180 Days After Expiration of the PHE Declaration, During Which Time 
FDA Plans to Further Revise the Guidances

    Based on our review, FDA has identified 24 COVID-19-related 
guidances that we intend to retain with appropriate changes after 
expiration of the COVID-19 PHE declaration. Therefore, FDA is revising 
the 24 guidances listed in table 3 to continue in effect for 180 days 
after the COVID-19 PHE declaration expires. During that time, FDA plans 
to further revise each of these guidances with any appropriate changes 
based on comments received and the Agency's experience with 
implementation. For example, FDA could revise a guidance so its 
duration aligns with an applicable declaration made under section 564 
of the FD&C Act enabling the issuance of EUAs, or by removing language 
describing intended duration. Once a revised final guidance is issued, 
which could occur sooner than 180 days after the PHE declaration 
expires, it will supersede the guidance listed in table 3.
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    \6\ FDA is revising the guidance ``Enforcement Policy for Face 
Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and 
Respirators During the Coronavirus Disease (COVID-19) Public Health 
Emergency (Revised)'' to split it into two separate guidance 
documents, each with identical policies to the corresponding parts 
of the September 2021 version. Concurrent with issuance of this 
guidance addressing face masks and barrier face coverings, FDA also 
is issuing ``Enforcement Policy for Face Shields, Surgical Masks, 
and Respirators During the Coronavirus Disease (COVID-19) Public 
Health Emergency.'' That guidance is listed in table 2 of this 
notice.

    Table 3--Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the PHE Declaration
                      Expires, During Which Time FDA Plans to Further Revise the Guidances
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137............................  CBER......................  Emergency Use Authorization for
                                                                          Vaccines to Prevent COVID-19.
FDA-2020-D-1825............................  CBER......................  Investigational COVID-19 Convalescent
                                                                          Plasma.
FDA-2015-D-1211............................  CBER......................  Revised Recommendations for Reducing
                                                                          the Risk of Human Immunodeficiency
                                                                          Virus Transmission by Blood and Blood
                                                                          Products.
FDA-2020-D-1137............................  CBER......................  Development and Licensure of Vaccines
                                                                          to Prevent COVID-19.
FDA-2020-D-1137............................  CBER......................  Alternative Procedures for Blood and
                                                                          Blood Components During the COVID-19
                                                                          Public Health Emergency.
FDA-2020-D-1106-0002.......................  CDER......................  FDA Guidance on Conduct of Clinical
                                                                          Trials of Medical Products during
                                                                          COVID-19 Public Health Emergency.
FDA-2020-D-1370............................  CDER......................  COVID-19: Developing Drugs and
                                                                          Biological Products for Treatment or
                                                                          Prevention.
FDA-2020-D-2016............................  CDER......................  Policy for Testing of Alcohol (Ethanol)
                                                                          and Isopropyl Alcohol for Methanol,
                                                                          Including During the COVID-19 Public
                                                                          Health Emergency (COVID-19).
FDA-2020-D-1136............................  CDER......................  COVID-19: Potency Assay Considerations
                                                                          for Monoclonal Antibodies and Other
                                                                          Therapeutic Proteins Targeting SARS-
                                                                          CoV-2 Infectivity.
FDA-2020-D-1824............................  CDER......................  Assessing COVID-19-Related Symptoms in
                                                                          Outpatient Adult and Adolescent
                                                                          Subjects in Clinical Trials of Drugs
                                                                          and Biological Products for COVID-19
                                                                          Prevention or Treatment.
FDA-2020-D-1414............................  CDER......................  Institutional Review Board (IRB) Review
                                                                          of Individual Patient Expanded Access
                                                                          Requests for Investigational Drugs and
                                                                          Biological Products During the COVID-
                                                                          19 Public Health Emergency Guidance
                                                                          for IRBs and Clinical Investigators.
FDA-2020-D-1057............................  CDER......................  Notifying FDA of a Permanent
                                                                          Discontinuance or Interruption in
                                                                          Manufacturing Under Section 506C of
                                                                          the FD&C Act Guidance for Industry
FDA-2021-D-0409............................  CDER......................  COVID-19: Master Protocols Evaluating
                                                                          Drugs and Biological Products for
                                                                          Treatment or Prevention.
FDA-2020-D-1136............................  CDER......................  Remote Interactive Evaluations of Drug
                                                                          Manufacturing and Bioresearch
                                                                          Monitoring Facilities During the COVID-
                                                                          19 Public Health Emergency Guidance
                                                                          for Industry.
FDA-2020-D-1136............................  CDER......................  COVID-19 Container Closure System and
                                                                          Component Changes: Glass Vials and
                                                                          Stoppers Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Development of Monoclonal Antibody
                                                                          Products Targeting SARS-CoV-2,
                                                                          Including Addressing the Impact of
                                                                          Emerging Variants, During the COVID 19
                                                                          Public Health Emergency.
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Face Masks and
                                                                          Barrier Face Coverings During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.\6\
FDA-2020-D-1138............................  CDRH......................  Supplements for Approved Premarket
                                                                          Approval (PMA) or Humanitarian Device
                                                                          Exemption (HDE) Submissions During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency (Revised).
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Clinical
                                                                          Electronic Thermometers During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Non-Invasive
                                                                          Remote Monitoring Devices Used to
                                                                          Support Patient Monitoring During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency (Revised).
FDA-2020-D-1139............................  CFSAN.....................  Returning Refrigerated Transport
                                                                          Vehicles and Refrigerated Storage
                                                                          Units to Food Uses After Using Them to
                                                                          Preserve Human Remains During the
                                                                          COVID-19 Pandemic.
FDA-2020-D-1108............................  CFSAN.....................  Temporary Policy Regarding Preventive
                                                                          Controls and FSVP Food Supplier
                                                                          Verification Onsite Audit Requirements
                                                                          During the COVID-19 Public Health
                                                                          Emergency.
FDA-2020-D-1304............................  CFSAN.....................  Temporary Policy Regarding Accredited
                                                                          Third-Party Certification Program
                                                                          Onsite Observation and Certificate
                                                                          Duration Requirements During the COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1140............................  CVM.......................  CVM GFI #271 Reporting and Mitigating
                                                                          Animal Drug Shortages during the COVID-
                                                                          19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------


[[Page 15422]]

V. Other COVID-19 Related Guidance Documents

    FDA also has issued the four guidance documents listed in table 4 
whose policies and recommendations have supported COVID-19 response 
efforts, but whose duration is not tied to the COVID-19 PHE 
declaration, and will remain in effect after expiration of the COVID-19 
PHE declaration. In January 2023, FDA revised the two guidances marked 
with an asterisk in table 4 to state their policies are intended to 
remain in effect only for the duration of the declaration under section 
564 of the FD&C Act by the Secretary of HHS on February 4, 2020, 
declaring that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostics for detection and/or diagnosis of 
the novel coronavirus (2019-nCoV) (85 FR 7316). These guidances 
previously stated that they were intended to remain in effect only for 
the duration of the PHE declaration.

                               Table 4--Other COVID-19-Related Guidance Documents
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
----------------------------------------------------------------------------------------------------------------
FDA-2007-D-0369............................  CDER......................  Product-Specific Guidances for
                                                                          Chloroquine and Hydroxychloroquine.
FDA-2008-D-0610............................  CDER......................  Postmarketing Adverse Event Reporting
                                                                          for Medical Products and Dietary
                                                                          Supplements During a Pandemic.
FDA-2020-D-0987............................  CDRH......................  Policy for Coronavirus Disease-2019
                                                                          Tests (Revised).*
FDA-2020-D-0987............................  CDRH......................  Policy for Evaluating Impact of Viral
                                                                          Mutations on COVID-19 Tests.*
----------------------------------------------------------------------------------------------------------------

VI. Electronic Access

    Persons with access to the internet may obtain the guidances listed 
in this notice at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: March 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05094 Filed 3-10-23; 8:45 am]
BILLING CODE 4164-01-P