Notice2023-05094
Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)
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Published
March 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 48 (Monday, March 13, 2023)</title>
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[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15417-15422]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx</a>. 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
<a href="https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf">https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf</a>),
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 <a href="https://www.fda.gov/media/163737/download">https://www.fda.gov/media/163737/download</a>.
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\2\ See 86 FR 55620 (October 6, 2021), available at <a href="https://www.federalregister.gov/documents/2021/10/06/2021-21798/guidance-documents-related-to-coronavirus-disease-2019-availability">https://www.federalregister.gov/documents/2021/10/06/2021-21798/guidance-documents-related-to-coronavirus-disease-2019-availability</a>; 86 FR
56960 (October 13, 2021), available at <a href="https://www.federalregister.gov/documents/2021/10/13/2021-22108/alcohol-based-hand-sanitizer-products-withdrawal-of-three-temporary-guidance-documents-issued-during">https://www.federalregister.gov/documents/2021/10/13/2021-22108/alcohol-based-hand-sanitizer-products-withdrawal-of-three-temporary-guidance-documents-issued-during</a>; 87 FR 34691 (June 7, 2022),
available at <a href="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">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</a>; 87 FR 78111 (December
21, 2022), available at <a href="https://www.federalregister.gov/documents/2022/12/21/2022-27673/enforcement-policy-regarding-federal-veterinarian-client-patient-relationship-requirements-to">https://www.federalregister.gov/documents/2022/12/21/2022-27673/enforcement-policy-regarding-federal-veterinarian-client-patient-relationship-requirements-to</a>; 88 FR 8872
(February 10, 2023), available at <a href="https://www.federalregister.gov/documents/2023/02/10/2023-02809/temporary-policy-on-repackaging-or-combining-propofol-drug-products-during-the-covid-19-public">https://www.federalregister.gov/documents/2023/02/10/2023-02809/temporary-policy-on-repackaging-or-combining-propofol-drug-products-during-the-covid-19-public</a>. 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 (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/withdrawn-guidances-biologics">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/withdrawn-guidances-biologics</a>).
\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
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Docket No. Lead center Title of guidance
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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.
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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
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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.
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[[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 <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
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
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</html>Indexed from Federal Register on March 13, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.