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

Federal RegisterMay 12, 2020

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice is pursuant to the process that FDA announced, in the

Federal Register

of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, document. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

DATES:

The announcement of the guidances is published in the

Federal Register

on May 12, 2020. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the name of the guidance document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

https://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))).

Submit written requests for single copies of any of these guidances to the addresses noted in table 1. Where applicable, send two self-addressed adhesive labels to assist that office in processing your requests. See the

SUPPLEMENTARY INFORMATION

section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Stephen Ripley, Center for Biologics Evaluation and Research, 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353; Phil Chao, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2112; Kimberly Thomas, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357; Diane Heinz, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5692.

SUPPLEMENTARY INFORMATION:

I. Background

On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services (HHS), pursuant to the authority under section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 247d), determined that a PHE exists and has existed since January 27, 2020, nationwide.

On March 13, 2020, President Donald J. Trump declared that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.

On April 21, 2020, the PHE Determination was extended, effective April 26, 2020. These PHE Determinations are available at

https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.

Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), available at

https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

In the

Federal Register

of March 25, 2020 (85 FR 16949) (the March 25, 2020, notice) (available at:

https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf

), FDA announced procedures for making available FDA guidance documents related to the COVID-19 PHE. These procedures, which operate within FDA's established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders. The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID-19 PHE, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidance documents. Therefore, FDA will issue COVID-19-related guidance documents for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C) and § 10.115(g)(2)). The guidances are available on FDA's web page “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (

https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-

related-guidance-documents-industry-fda-staff-and-other-stakeholders

) and through FDA's web page “Search for FDA Guidance Documents” (

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

The March 25, 2020, notice further stated that, in general, rather than publishing a separate notice of availability (NOA) for each COVID-19-related guidance document, FDA intends to publish periodically a consolidated NOA announcing the availability of COVID-19-related guidance documents FDA issued during the relevant period. This notice announces certain COVID-19-related guidances that are posted on FDA's website, as included in table 1.

Lastly, the March 25, 2020, notice indicated that, in general, guidance documents would be placed in dockets established for COVID-19-related guidance documents issued by each Center. As noted in table 1, certain COVID-19-related guidance documents issued by the Center for Drug Evaluation and Research (CDER) prior to March 24, 2020, were placed in Docket No. FDA-2020-D-1106. FDA anticipates that, in general, CDER will use Docket No. FDA-2020-D-1136 for additional COVID-19-related guidance documents issued pursuant to the process described in the March 25, 2020, notice.

II. Availability of COVID-19-Related Guidance Documents

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

Table 1— Guidances Related to the COVID-19 Public Health Emergency

Docket No.

Center/office

Title of guidance

Contact information to request

single copies

FDA-2020-D-1137

Center for Biologics Evaluation and Research (CBER)

Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency (April 2020)

Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 1-800-835-4709 or 240-402-8010; email

ocod@fda.hhs.gov.

FDA-2020-D-1138

Center for Devices and Radiological Health (CDRH)

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency (March 2020)

CDRH-Guidance@fda.hhs.gov.

Please include the document number 20014 and complete title of the guidance in the request.

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 (March 2020)

CDRH-Guidance@fda.hhs.gov.

Please include the document number 20015 and complete title of the guidance in the request.

FDA-2020-D-1138

CDRH

Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020)

CDRH-Guidance@fda.hhs.gov

Please include the document number 20019 and complete title of the guidance in the request.

FDA-2020-D-1138

CDRH

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency (March 2020)

CDRH-Guidance@fda.hhs.gov

Please include the document number 20020 and complete title of the guidance in the request.

FDA-2020-D-1138

CDRH

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Issued March 25, 2020) (Revised April 2, 2020)

CDRH-Guidance@fda.hhs.gov.

Please include the document number 20018 and complete title of the guidance in the request.

FDA-2020-D-1139

Center for Food Safety and Applied Nutrition (CFSAN)

Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (March 2020)

Office of Nutrition and Food Labeling, Food Labeling and Standards Staff, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

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 (April 2020)

Office of Nutrition and Food Labeling, Food Labeling and Standards Staff, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

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 (April 2020)

Office of Nutrition and Food Labeling, Food Labeling and Standards Staff, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

FDA-2020-D-1106

CDER

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (March 18, 2020) (Updated March 27, 2020, April 2, 2020, and April 16, 2020)

Clinicaltrialconduct-COVID19@fda.hhs.gov.