2020-11238. 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 of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances 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 26, 2020. The guidances 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(s) 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 21 CFR 10.115(g)(5)). Submit written requests for single copies of any of these guidances to the addresses noted in table 1. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, 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 (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357; Phil Chao, Center for Food Safety and Applied Nutrition (CFSAN), CPK1 Rm 1C001, HFS-024, Food and Drug Administration, College Park, MD 20740, 240-402-2112.

SUPPLEMENTARY INFORMATION:

I. Background

On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.^[1] On March 13, 2020, President Donald J. Trump declared that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.^[2]

In the Federal Register of March 25, 2020 (the March 25, 2020, notice) (available at: https://www.govinfo.gov/​content/​pkg/​FR-2020-03-25/​pdf/​2020-06222.pdf), FDA announced procedures for making available FDA guidances 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 guidances. Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (§ 10.115(g)(2))). The guidances are available at FDA's web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled “Search for FDA Guidance Documents” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents.

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

II. Availability of COVID-19-Related Guidances

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

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	CBER	Investigatory COVID-19 Convalescent Plasma (April 2020) (Updated May 1, 2020)	Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 1-800-835-4709 or 240-402-8010, email [e-mail].
FDA-2020-D-1138	CDRH	Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 4, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
FDA-2020-D-1138	CDRH	Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 5, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
FDA-2020-D-1138	CDRH	Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 6, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
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 (April 6, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
FDA-2020-D-1138	CDRH	Enforcement Policy for Digital Health Devices for Treating Psychological Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 14, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
FDA-2020-D-1138	CDRH	Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 16, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
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 (April 23, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
FDA-2020-D-1138	CDRH	Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 23, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
FDA-2020-D-1138	CDRH	Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 24, 2020)	[e-mail] Please include the document number 20014 and complete title of the guidance in the request.
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 (April 10, 2020)	[e-mail] Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.
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 (April 2020) (Updated April 20, 2020)	[e-mail] Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.
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 (April 16, 2020) (Updated May 8, 2020)	[e-mail] Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.
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 (April 20, 2020) (Updated May 8, 2020)	[e-mail] Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.
FDA-2020-D-1136	CDER	Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency (April 22, 2020)	[e-mail] Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request.
FDA-2020-D-1139	CFSAN	Temporary Policy on Regulatory Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency (April 6, 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.

Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)).

These guidances are being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER

The guidance indicated below refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (PRA). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:

Table 2—CBER Guidance

COVID-19 guidance title	CFR cite referenced in COVID-19 guidance	Another guidance title referenced in COVID-19 guidance	OMB control No(s).
Investigatory COVID-19 Convalescent Plasma	21 CFR part 312 >21 CFR 606.121	N/A	0910-0014 0910-0116
	21 CFR part 630		0910-0116
	Form FDA 3926		0910-0814

B. CDRH

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

C. CDER

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

Table 4—Guidances and Regulations

COVID-19 guidance title	CFR or FD&C Act cite referenced in COVID-19 guidance	Another guidance title referenced in COVID-19 guidance	OMB control No(s).
Policy for Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94 for Oxygen and Nitrogen During COVID-19 Public Health Emergency	21 CFR parts 201, 210, 211.84, 211.94, and 211.100	Current Good Manufacturing Practice for Medical Gases Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements	0910-0139
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency	21 CFR 314.81, 21 CFR 600.82, Section 503B(b)(1)(A)(i) of the FD&C Act (21 U.S.C. 353b(b)(1)(A)(i)	Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act	0910-0777 0910-0338 0910-0001 0910-0139
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		Compounded Drug Products That are Essentially Copies of a Commercially Available Drug Product under Section 503A of the Federal Food, Drug and Cosmetic Act Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act 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	0910-0001 0910-0139 0910-0338
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency		Repackaging of Certain Human Drugs by Pharmacies and Outsourcing Facilities 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 Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency	0910-0139 0910-0572 0910-0777 0910-0800

The guidance indicated below refers to previously approved collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the below table. This guidance also contains a new collection of information not approved under a current collection. This new collection of information has been granted a PHE waiver from the PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/​public-health-emergency-declaration-pra-waivers.

Table 5—New PRA Information Collection

COVID-19 guidance title	CFR cite referenced in COVID-19 guidance	Another guidance referenced in COVID-19 guidance	OMB control No.	New collection covered by PHE PRA waiver
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	21 CFR parts 210 and 211	Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act	0910-0139	Recordkeeping of compounding without standard PPE; recordkeeping of any change of sterilization/aseptic processing methods; documentation of mitigation strategies for sterile compounding without standard PPE.

D. CFSAN

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

Table 6—CFSAN Guidance

COVID-19 guidance title	CFR cite referenced in COVID-19 guidance	Another guidance title referenced in COVID-19 guidance	OMB control No.
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency	21 CFR part 118		0910-0660

IV. Electronic Access

Persons with access to the internet may obtain COVID-19-related guidances at:

• the FDA web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,” available at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;​;
• the FDA web page entitled “Search for FDA Guidance Documents,” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents;​; or
• https://www.regulations.gov.

Dated: May 19, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

Footnotes

1.  On April 21, 2020, the PHE Determination was extended, effective April 26, 2020. These PHE Determinations are available at https://www.phe.gov/​emergency/​news/​healthactions/​phe/​Pages/​default.aspx.

2.  Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), available at https://www.whitehouse.gov/​presidential-actions/​proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/​.