# Guidance Documents Related to Coronavirus Disease 2019; 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 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 August 3, 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 21 CFR 10.115(g)(5)). Submit written requests for single copies of these guidances to the address 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. 7301, Silver Spring, MD 20993-0002, 240- 402-7911; 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; Erica Takai, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, HFZ-450, Silver Spring, MD 20993-0002, 301-796-6353; 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; Diane Heinz, Center for Veterinary Medicine (CVM), Food and Drug Administration, MPN2 RME435 HFV-6, 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, pursuant to the authority under section 319 of the Public Health Service Act (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]
[^1] On April 21, 2020, the PHE Determination was extended, effective April 26, 2020; on July 23, 2020, it was extended again, effective July 25, 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/.*
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 21 CFR 10.115(g)(2) (§ 10.115(g)(2))). The guidances are available at FDA's web page titled “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 titled “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 document, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID-19-related guidance documents that 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 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:
| Docket No. | Center | Title of guidance | Contact information to request single copies |
| --- | --- | --- | --- |
| FDA-2020-D-1106 | CDER | Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March 2020) (Updated June 1, 2020) | Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request. |
| FDA-2020-D-1106 | CDER | Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (March 2020) (Updated June 1, 2020) | Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request. |
| FDA-2020-D-1106 | CDER | Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March 2020) (Updated June 1, 2020) | Please include the docket number FDA-2020-D-1106 and complete title of the guidance in the request. |
| 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 (June 8, 2020) | Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request. |
| FDA-2020-D-1136 | CDER | Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry (June 2020) | Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request. |
| FDA-2020-D-1136 | CDER, CVM, CBER | Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing (June 2020) | Please include the docket number FDA-2020-D-1136 and complete title of the guidance in the request. |
| FDA-2020-D-1137 | CBER | Development and Licensure of Vaccines to Prevent COVID-19 (June 2020) | Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Phone 1-800-835-4709 or 240-402-8010, email |
| 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) (March 20, 2020) (Updated June 5, 2020) | Please include the document number 20014 and complete title of the guidance in the request. |
| 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 (May 6, 2020) (Updated June 19, 2020) | Please include the document number 20032 and complete title of the guidance in the request. |
| FDA-2020-D-1138 | CDRH, CBER | Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices—Questions and Answers (June 2020) | Please include the document number 20040 and complete title of the guidance in the request. |
| 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 (May 27, 2020) | . Please include the docket number, FDA-2020-D-1139, and complete title of the guidance in the request. |
Although these guidance documents 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. CDER Guidances**
The guidances listed in the table below refer 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 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:
| COVID-19 guidance title | CFR cite referenced in COVID-19 guidance | Another guidance referenced in COVID-19 guidance | OMB Control No(s). |
| --- | --- | --- | --- |
| Good Manufacturing Practice Considerations for Responding to COVID-19 Infections in Employees in Drug and Biological Products Manufacturing—June 2020 | 21 CFR 211, 211.22, 211.28(d), 211.100 | (1) ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients | 0910-0130 |
| Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples during the COVID-19 Public Health Emergency—Guidance for Industry | 21 CFR 203 | | 0910-0435 |
| Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)—UPDATE of guidance announced in March 2020 | 27 CFR Part 20 and 21 | (1) Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) | 0910-0045 |
| Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)—UPDATE of guidance announced in March 2020 | 27 CFR Part 20 and 21 | None | 0910-0045 |
| Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry—UPDATE of guidance announced in March 2020 | | (1) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) | 0910-0045 |
The guidance, Statistical Considerations for Clinical Trials during the COVID-19 Public Health Emergency, contains no collection of information. Therefore, clearance by OMB under the PRA is not required.
**B. CBER Guidances**
The guidance listed in the table below refer to previously approved collection of information. This collection of information is subject to review by the OMB under the PRA. The collection of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:
| COVID-19 guidance title | CFR cite referenced | Another guidance title referenced | OMB Control No(s). |
| --- | --- | --- | --- |
| Development and Licensure of Vaccines to Prevent COVID-19 | 21 CFR part 312 | | 0910-0114 |
| | 21 CFR part 50 | | 0910-0130 |
| | 21 CFR parts 210, 211, and 610 | | 0910-0139 |
| | 221 CFR part 600 | | 0910-0308 |
| | 221 CFR part 601 | | 0910-0338 |
| | | —Form FDA 3500A | 0910-0291 |
**C. CDRH Guidances**
The guidances listed in the table 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:
| COVID-19 guidance title | CFR cite referenced | Another guidance title referenced | OMB Control No(s). |
| --- | --- | --- | --- |
| Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) (March 20, 2020) (Updated June 5, 2020) | 807, subpart E | | 0910-0120 |
| Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices—Questions and Answers (June 22, 2020) | | Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff | 0910-0756 |
| | | Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders | 0910-0595 |
| | 814, subparts A through E | | 0910-0231 |
| | 807, subpart E | | 0910-0120 |
| | | De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff | 0910-0844 |
| | 814, subpart H | | 0910-0332 |
| | 812 | | 0910-0078 |
The guidance indicated in the table below refers to previously approved collections of information. These collections of information are subject to review by the OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the 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 the Department of Health and Human Services (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.*
| COVID-19 guidance title | CFR cite | Another guidance referenced | OMB Control No(s). | New collection covered by |
| --- | --- | --- | --- | --- |
| Notifying CDRH of 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) (May 6, 2020) (Updated June 19, 2020) | 807, subparts A through D | | 0910-0625 | |
| | | | | Notifications to FDA about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. |
| | | | | Updates to FDA every two weeks after initial notification on the shortage situation, including the expected timeline for recovery. |
| | | | | Voluntary submission of other information that enables FDA to work more effectively with manufacturers and other entities to prevent or limit any negative impact on patients or healthcare providers during the COVID-19 public health emergency. |
**D. CFSAN Guidances**
The guidance indicated in the table below refers to previously approved collections of information. These collections of information are subject to review by the OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the 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.*
| COVID-19 guidance title | CFR cite | Another guidance referenced in COVID-19 guidance | OMB Control No(s). | New Collection covered by |
| --- | --- | --- | --- | --- |
| Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency | 21 CFR part 1, subpart H | | 0910-0502 | Establishments have the option to report to FDA temporary closures or significant reductions of production and to request assistance from FDA. |
**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: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.