Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Published date | 26 May 2020 |
Citation | 85 FR 31513 |
Record Number | 2020-11238 |
Section | Notices |
Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 101 (Tuesday, May 26, 2020)
[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)] [Notices] [Pages 31513-31520] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-11238] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2020-D-1136, FDA-2020-D-1137, FDA-2020-D-1138, FDA- 2020-D-1139] 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 [[Page 31514]] 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\ --------------------------------------------------------------------------- \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/. --------------------------------------------------------------------------- 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) (Sec. 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 ---------------------------------------------------------------------------------------------------------------- Contact information to Docket No. Center/office Title of guidance request single copies ---------------------------------------------------------------------------------------------------------------- FDA-2020-D-1137................... CBER Investigatory COVID-19 Office of Communication, Convalescent Plasma Outreach and (April 2020) (Updated Development, 10903 New May 1, 2020). Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 1- 800-835-4709 or 240-402- 8010, email [email protected]. FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Clinical Electronic Please include the Thermometers During the document number 20014 Coronavirus Disease 2019 and complete title of (COVID-19) Public Health the guidance in the Emergency (April 4, request. 2020). FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Infusion Pumps and Please include the Accessories During the document number 20014 Coronavirus Disease 2019 and complete title of (COVID-19) Public Health the guidance in the Emergency (April 5, request. 2020). [[Page 31515]] FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Remote Ophthalmic Please include the Assessment and document number 20014 Monitoring Devices and complete title of During the Coronavirus the guidance in the Disease 2019 (COVID-19) request. Public Health Emergency (April 6, 2020). FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Extracorporeal Membrane Please include the Oxygenation and document number 20014 Cardiopulmonary Bypass and complete title of Devices During the the guidance in the Coronavirus Disease 2019 request. (COVID-19) Public Health Emergency (April 6, 2020). FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Digital Health Devices Please include the for Treating document number 20014 Psychological Disorders and complete title of During the Coronavirus the guidance in the Disease 2019 (COVID-19) request. Public Health Emergency (April 14, 2020). FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Telethermographic Please include the Systems During the document number 20014 Coronavirus Disease 2019 and complete title of (COVID-19) Public Health the guidance in the Emergency (April 16, request. 2020). FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Non-Invasive Fetal and Please include the Maternal Monitoring document number 20014 Devices Used to Support and complete title of Patient Monitoring the guidance in the During the Coronavirus request. Disease 2019 (COVID-19) Public Health Emergency (April 23, 2020). FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Imaging Systems During Please include the the Coronavirus Disease document number 20014 2019 (COVID-19) Public and complete title of Health Emergency (April the guidance in the 23, 2020). request. FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected] Remote Digital Pathology Please include the Devices During the document number 20014 Coronavirus Disease 2019 and complete title of (COVID-19) Public Health the guidance in the Emergency (April 24, request. 2020). FDA-2020-D-1136................... CDER Temporary Policy [email protected] Regarding Non-Standard Please include the docket PPE Practices for number FDA-2020-D-1136 Sterile Compounding by and complete title of Pharmacy Compounders not the guidance in the Registered as request. Outsourcing Facilities During the COVID-19 Public Health Emergency (April 10, 2020). FDA-2020-D-1136................... CDER Policy for the Temporary [email protected] Use of Portable Please include the docket Cryogenic Containers Not number FDA-2020-D-1136 in Compliance With 21 and complete title of CFR 211.94(e)(1) For the guidance in the Oxygen and Nitrogen request. During the COVID-19 Public Health Emergency (April 2020) (Updated April 20, 2020). FDA-2020-D-1136................... CDER Temporary Policy for [email protected] Compounding of Certain Please include the docket Drugs for Hospitalized number FDA-2020-D-1136 Patients by Outsourcing and complete title of Facilities During the the guidance in the COVID-19 Public Health request. Emergency (April 16, 2020) (Updated May 8, 2020). FDA-2020-D-1136................... CDER Temporary Policy for [email protected] Compounding of Certain Please include the docket Drugs for Hospitalized number FDA-2020-D-1136 Patients by Pharmacy and complete title of Compounders not the guidance in the Registered as request. Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry (April 20, 2020) (Updated May 8, 2020). FDA-2020-D-1136................... CDER Temporary Policy on [email protected] Repackaging or Combining Please include the docket Propofol Drug Products number FDA-2020-D-1136 During the COVID-19 and complete title of Public Health Emergency the guidance in the (April 22, 2020). request. FDA-2020-D-1139................... CFSAN Temporary Policy on Office of Nutrition and Regulatory Enforcement Food Labeling, Food of 21 CFR Part 118 (the Labeling and Standards Egg Safety Rule) During Staff, Center for Food the COVID-19 Public Safety and Applied Health Emergency (April Nutrition, Food and Drug 6, 2020). 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 Sec. 10.115(g)(3)). These guidances are being issued consistent with FDA's good guidance practices regulation (Sec. 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 [[Page 31516]] 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 ---------------------------------------------------------------------------------------------------------------- Another guidance title COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control COVID-19 guidance guidance No(s). ---------------------------------------------------------------------------------------------------------------- Investigatory COVID-19 Convalescent 21 CFR part 312........... N/A....................... 0910-0014 Plasma. >21 CFR 606.121........... .......................... 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: BILLING CODE 4164-01-P [[Page 31517]] [GRAPHIC] [TIFF OMITTED] TN26MY20.026 [[Page 31518]] [GRAPHIC] [TIFF OMITTED] TN26MY20.027 BILLING CODE 4164-01-C 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 ---------------------------------------------------------------------------------------------------------------- CFR or FD&C Act cite COVID-19 guidance title referenced in COVID-19 Another guidance title OMB control guidance referenced in COVID-19 No(s). --------------------------------------------------------------------------------guidance------------------------ Policy for Temporary Use of Portable 21 CFR parts 201, 210, Current Good Manufacturing 0910-0139 Cryogenic Containers Not in Compliance 211.84, 211.94, and Practice for Medical Gases With 21 CFR 211.94 for Oxygen and 211.100. Medical Gas Containers and Nitrogen During COVID-19 Public Health Closures; Current Good Emergency. Manufacturing Practice Requirements. Temporary Policy for Compounding of 21 CFR 314.81, 21 CFR Current Good Manufacturing 0910-0777 Certain Drugs for Hospitalized 600.82, Section Practice--Guidance for Human 0910-0338 Patients by Outsourcing Facilities 503B(b)(1)(A)(i) of the Drug Compounding Outsourcing 0910-0001 During the COVID-19 Public Health FD&C Act (21 U.S.C. Facilities Under Section 503B 0910-0139 Emergency. 353b(b)(1)(A)(i). of the FD&C Act. [[Page 31519]] Temporary Policy for Compounding of .......................... Compounded Drug Products That 0910-0001 Certain Drugs for Hospitalized are Essentially Copies of a 0910-0139 Patients by Pharmacy Compounders not Commercially Available Drug 0910-0338 Registered as Outsourcing Facilities Product under Section 503A of During the COVID-19 Public Health the Federal Food, Drug and Emergency. 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. Temporary Policy on Repackaging or .......................... Repackaging of Certain Human 0910-0139 Combining Propofol Drug Products Drugs by Pharmacies and 0910-0572 During the COVID-19 Public Health Outsourcing Facilities. 0910-0777 Emergency. Temporary Policy for 0910-0800 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. ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- CFR cite Another guidance COVID-19 guidance title referenced in referenced in COVID-19 OMB control New collection covered COVID-19 guidance guidance No. by PHE PRA waiver ---------------------------------------------------------------------------------------------------------------- Temporary Policy Regarding Non- 21 CFR parts 210 Enforcement Policy for 0910-0139 Recordkeeping of Standard PPE Practices for and 211. Face Masks and compounding without Sterile Compounding by Respirators During standard PPE; Pharmacy Compounders not the Coronavirus recordkeeping of any Registered as Outsourcing Disease (COVID-19) change of Facilities During the COVID-19 Public Health sterilization/aseptic Public Health Emergency. Emergency (Revised). processing methods; Enforcement Policy for documentation of Gowns, Other Apparel, mitigation strategies and Gloves During the for sterile Coronavirus Disease compounding without (COVID-19) Public standard PPE. Health Emergency. Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. ---------------------------------------------------------------------------------------------------------------- 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: [[Page 31520]] Table 6--CFSAN Guidance ---------------------------------------------------------------------------------------------------------------- Another guidance title COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control COVID-19 guidance guidance No. ---------------------------------------------------------------------------------------------------------------- Temporary Policy Regarding Enforcement of 21 CFR part 118............ ........................... 0910-0660 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency. ---------------------------------------------------------------------------------------------------------------- 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. [FR Doc. 2020-11238 Filed 5-22-20; 8:45 am] BILLING CODE 4164-01-P