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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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. 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%2011%2C%202023 ).

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 withdrawal of, several COVID-19-related guidances after determining that the policies no longer represented the Agency's current thinking. 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. 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.

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. 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.

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 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.

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.

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.

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.