[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)] [Notices] [Pages 28010-28016] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-10146] ----------------------------------------------------------------------- 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: [[Page 28011]] 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 Sec. 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.\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 (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 Sec. 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- [[Page 28012]] 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 ---------------------------------------------------------------------------------------------------------------- Contact information to request Docket No. Center/office Title of guidance single copies ---------------------------------------------------------------------------------------------------------------- FDA-2020-D-1137........ Center for Biologics Alternative Procedures for Office of Communication, Evaluation and Blood and Blood Components Outreach and Development, Research (CBER). During the COVID-19 Public Center for Biologics Health Emergency (April 2020). 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 [email protected]. FDA-2020-D-1138........ Center for Devices and Enforcement Policy for Non- [email protected]. Radiological Health Invasive Remote Monitoring Please include the document (CDRH). Devices Used to Support number 20014 and complete Patient Monitoring During the title of the guidance in the Coronavirus Disease-2019 request. (COVID-19) Public Health Emergency (March 2020). FDA-2020-D-1138........ CDRH................... Enforcement Policy for [email protected]. Ventilators and Accessories Please include the document and Other Respiratory Devices number 20015 and complete During the Coronavirus title of the guidance in the Disease 2019 (COVID-19) request. Public Health Emergency (March 2020). FDA-2020-D-1138........ CDRH................... Enforcement Policy for [email protected] Sterilizers, Disinfectant Please include the document Devices, and Air Purifiers number 20019 and complete During the Coronavirus title of the guidance in the Disease 2019 (COVID-19) request. Public Health Emergency (March 2020). FDA-2020-D-1138........ CDRH................... Enforcement Policy for Gowns, [email protected] Other Apparel, and Gloves Please include the document During the Coronavirus number 20020 and complete Disease (COVID-19) Public title of the guidance in the Health Emergency (March 2020). request. FDA-2020-D-1138........ CDRH................... Enforcement Policy for Face [email protected]. Masks and Respirators During Please include the document the Coronavirus Disease number 20018 and complete (COVID-19) Public Health title of the guidance in the Emergency (Issued March 25, request. 2020) (Revised April 2, 2020). FDA-2020-D-1139........ Center for Food Safety Temporary Policy Regarding Office of Nutrition and Food and Applied Nutrition Nutrition Labeling of Certain Labeling, Food Labeling and (CFSAN). Packaged Food During the Standards Staff, Center for COVID-19 Public Health Food Safety and Applied Emergency (March 2020). Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. FDA-2020-D-1139........ CFSAN.................. Temporary Policy Regarding Office of Nutrition and Food Nutrition Labeling of Labeling, Food Labeling and Standard Menu Items in Chain Standards Staff, Center for Restaurants and Similar Food Safety and Applied Retail Food Establishments Nutrition, Food and Drug During the COVID-19 Public Administration, 5001 Campus Health Emergency (April 2020). Dr., College Park, MD 20740. FDA-2020-D-1139........ CFSAN.................. Temporary Policy Regarding Office of Nutrition and Food Packaging and Labeling of Labeling, Food Labeling and Shell Eggs Sold by Retail Standards Staff, Center for Food Establishments During Food Safety and Applied the COVID-19 Public Health Nutrition, Food and Drug Emergency (April 2020). Administration, 5001 Campus Dr., College Park, MD 20740. FDA-2020-D-1106........ CDER................... FDA Guidance on Conduct of Clinicaltrialconduct- Clinical Trials of Medical [email protected]. Please Products during COVID-19 include the docket number FDA- Public Health Emergency 2020-D-1106 and complete (March 18, 2020) (Updated title of the guidance in the March 27, 2020, April 2, request. 2020, and April 16, 2020). FDA-2020-D-1106........ CDER................... Temporary Policy for [email protected]. Please Preparation of Certain include the docket number FDA- Alcohol-Based Hand Sanitizer 2020-D-1106 and complete Products During the Public title of the guidance in the Health Emergency (COVID-19) request. (March 19, 2020) (Updated March 27, 2020, and April 15, 2020). [[Page 28013]] FDA-2020-D-1106........ CDER................... Policy for Certain REMS [email protected]. Please Requirements During the COVID- include the docket number FDA- 19 Public Health Emergency 2020-D-1106 and complete (March 2020). title of the guidance in the request. FDA-2020-D-1106........ CDER................... Temporary Policy for [email protected]. Please Manufacture of Alcohol for include the docket number FDA- Incorporation Into Alcohol- 2020-D-1106 and complete Based Hand Sanitizer Products title of the guidance in the During the Public Health request. Emergency (COVID-19) Guidance for Industry (March 24, 2020) (Updated March 27, 2020, and April 15, 2020). FDA-2020-D-1106........ CDER................... Policy for Temporary [email protected]. Please Compounding of Certain include the docket number FDA- Alcohol-Based Hand Sanitizer 2020-D-1106 and complete Products During the Public title of the guidance in the Health Emergency (March 2020) request. (Updated April 15, 2020). FDA-2020-D-1140........ Center for Veterinary CVM GFI #269--Enforcement [email protected]. Please Medicine (CVM). Policy Regarding Federal VCPR include the docket number FDA- Requirements to Facilitate 2020-D-1140 and complete Veterinary Telemedicine title of the guidance in the During the COVID-19 Outbreak request. (March 2020). FDA-2020-D-1140........ CVM.................... CVM GFI #270--Guidance on the [email protected]. Conduct and Review of Studies Please include the docket to Support New Animal Drug number FDA-2020-D-1140 and Development during the COVID- complete title of the 19 Public Health Emergency guidance in the request. (April 2020). ---------------------------------------------------------------------------------------------------------------- Although these guidance documents 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)). III. Significance of Guidances 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. IV. Paperwork Reduction Act of 1995 A. Center for Biologics Evaluation and Research This guidance 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: ---------------------------------------------------------------------------------------------------------------- Another guidance title COVID-19 guidance title 21 CFR Cite referenced in referenced in COVID-19 OMB Control COVID-19 guidance guidance No(s). ---------------------------------------------------------------------------------------------------------------- Alternative Procedures for Blood and 601.12.................... N/A....................... 0910-0338 Blood Components During the COVID-19 640.120................... 0910-0338 Public Health Emergency. part 630.................. 0910-0116 ---------------------------------------------------------------------------------------------------------------- B. Center for Devices and Radiological Health These guidances 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: ---------------------------------------------------------------------------------------------------------------- Another guidance title COVID-19 guidance title 21 CFR Cite referenced in referenced in COVID-19 OMB Control COVID-19 Guidance guidance No(s). ---------------------------------------------------------------------------------------------------------------- Enforcement Policy for Non-Invasive 807, subpart E............ .......................... 0910-0120 Remote Monitoring Devices Used to 800, 801, and 809......... 0910-0485 Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. Enforcement Policy for Ventilators and 800, 801, and 809......... 0910-0485 Accessories and Other Respiratory 803....................... 0910-0437 Devices During the Coronavirus Disease 807, subpart E............ 0910-0120 2019 (COVID-19) Public Health Emergency. 812....................... 0910-0078 820....................... 0910-0073 [[Page 28014]] Emergency Use 0910-0595 Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders. Enforcement Policy for Sterilizers, 800, 801, and 809......... 0910-0485 Disinfectant Devices, and Air Purifiers 807, subpart E............ 0910-0120 During the Coronavirus Disease 2019 807, subparts A through D. 0910-0625 (COVID-19) Public Health Emergency. 814, subparts A through E. 0910-0231 820....................... 0910-0073 830 and 801.20............ 0910-0720 Enforcement Policy for Gowns, Other 800, 801, and 809......... 0910-0485 Apparel, and Gloves During the 806....................... 0910-0359 Coronavirus Disease (COVID-19) Public 807, subparts A through D. 0910-0625 Health Emergency. 807, subpart E............ 0910-0120 820....................... 0910-0073 830 and 801.20............ 0910-0720 Enforcement Policy for Face Masks and 800, 801, and 809......... 0910-0485 Respirators During the Coronavirus 803....................... 0910-0437 Disease (COVID-19) Public Health 806....................... 0910-0359 Emergency (Revised). 807, subpart E............ 0910-0120 807, subparts A through D. 0910-0625 820 0910-0073 830 and 801.20............ 0910-0720 Emergency Use 0910-0595 Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders. ---------------------------------------------------------------------------------------------------------------- C. Center for Food Safety and Applied Nutrition These guidances 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: ---------------------------------------------------------------------------------------------------------------- Another guidance title COVID-19 guidance title 21 CFR Cite referenced in referenced in COVID-19 OMB Control COVID-19 guidance guidance No(s). ---------------------------------------------------------------------------------------------------------------- Temporary Policy Regarding Nutrition 101.11.................... .......................... 0910-0782 Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency. Temporary Policy Regarding Packaging and part 101.................. Temporary Policy Regarding 0910-0381 Labeling of Shell Eggs Sold by Retail Nutrition Labeling of Food Establishments During the COVID-19 Certain Packaged Food Public Health Emergency. During the COVID19 Public Health Emergency; 0910- 0381, 0910-0792. ---------------------------------------------------------------------------------------------------------------- This guidance 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 table below. 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. [[Page 28015]] ---------------------------------------------------------------------------------------------------------------- 21 CFR Cite Another guidance New collection COVID-19 guidance title referenced in referenced in COVID-19 OMB Control covered by PHE PRA COVID-19 guidance No(s). waiver -----------------------------------guidance--------------------------------------------------------------------- Temporary Policy Regarding part 101; ......................... 0910-0381, If a food product Nutrition Labeling of section 403(w) 0910-0792 does not have the Certain Packaged Food During of the FD&C Act required labeling the COVID-19 Public Health (21 U.S.C. information, a Emergency. 343(w)). restaurant may create a label to include this information (new respondent). ---------------------------------------------------------------------------------------------------------------- D. Center for Drug Evaluation and Research This guidance 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 guidances have been approved by OMB as listed in the following table: ---------------------------------------------------------------------------------------------------------------- 21 CFR Cite referenced in Another guidance referenced in OMB Control COVID-19 guidance title COVID-19 COVID-19 guidance No(s). guidance ---------------------------------------------------------------------------------------------------------------- FDA Guidance on Conduct of Clinical Trials 50.27(a) Use of Electronic Informed Consent 0910-0001 of Medical Products during COVID-19 Public 312.30 in Clinical Investigations. 0910-0014 Health Emergency (Updated). 312.60 0910-0755 312.62 812.35(a) 812.140 ---------------------------------------------------------------------------------------------------------------- These guidances 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 table below. These guidances also contain 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. -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 CFR Cite referenced in Another guidance referenced in COVID- OMB Control New collection covered by COVID-19 guidance title COVID-19 guidance 19 guidance No(s). PHE PRA waiver -------------------------------------------------------------------------------------------------------------------------------------------------------- Temporary Policy for Preparation of ........................... Policy for Temporary Compounding of 0910-0045 For proposed use of an Certain Alcohol-Based Hand Sanitizer Certain Alcohol-Based Hand Sanitizer 0910-0139 alternative grade of Products During the Public Health Products During the Public Health 0910-0230 ethanol, firms are Emergency (COVID-19). Emergency. 0910-0291 requested to submit to FDA Temporary Policy for Manufacture of 0910-0340 information on the ethanol Alcohol for Incorporation Into 0910-0641 concentration and levels of Alcohol-Based Hand Sanitizer Products 0910-0645 impurities listed in the During the Public Health Emergency 0910-0800 USP monograph and other (COVID-19). potentially harmful Providing Regulatory Submissions in impurities in the Electronic Format--Drug Establishment manufacturing environment. Registration and Drug Listing. Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application. [[Page 28016]] Policy for Temporary Compounding of ........................... Current Good Manufacturing Practices 0910-0139 For proposed use of an Certain Alcohol-Based Hand Sanitizer for Finished Pharmaceuticals and 0910-0230 alternative grade of Products During the Public Health Medical Gases. 0910-0291 ethanol, firms are Emergency (Updated). Postmarketing Adverse Drug Experience 0910-0340 requested to submit to FDA Reporting. 0910-0645 information on the ethanol MedWatch: Adverse Event and Product concentration and levels of Experience Reporting System (Paper- impurities listed in the Based). USP monograph and other Format and Content Requirements for potentially harmful Over-the-Counter Drug Product impurities in the Labeling. manufacturing environment. FDA Adverse Event and Product Experience Reports; Electronic Submissions. Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Temporary Policy for Manufacture of ........................... Policy for Temporary Compounding of 0910-0045 For proposed use of an Alcohol for Incorporation Into Certain Alcohol-Based Hand Sanitizer 0910-0139 alternative grade of Alcohol-Based Hand Sanitizer Products During the Public Health 0910-0230 ethanol, firms are Products During the Public Health Emergency. 0910-0291 requested to submit to FDA Emergency (COVID-19). Temporary Policy for Preparation of 0910-0340 information on the ethanol Certain Alcohol-Based Hand Sanitizer 0910-0641 concentration and levels of Products During the Public Health 0910-0645 impurities listed in the Emergency (COVID-19). USP monograph and other Providing Regulatory Submissions in potentially harmful Electronic Format--Drug Establishment impurities in the Registration and Drug Listing. manufacturing environment. -------------------------------------------------------------------------------------------------------------------------------------------------------- The final guidance entitled ``Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency'' contains no collection of information. Therefore, clearance by OMB under the PRA is not required. E. Center for Veterinary Medicine This guidance 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: ---------------------------------------------------------------------------------------------------------------- Another guidance title COVID-19 guidance title 21 CFR Cite referenced referenced in COVID-19 OMB Control in COVID-19 guidance guidance No(s). ---------------------------------------------------------------------------------------------------------------- GFI #270--Guidance on the Conduct and Review ....................... FDA Guidance on Conduct 0910-0032 of Studies to Support New Animal Drug of Clinical Trials of 0910-0669 Development during the COVID-19 Public Medical Products during Health Emergency. COVID-19 Public Health Emergency. ---------------------------------------------------------------------------------------------------------------- The final guidance entitled ``GFI #269--Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak'' contains no collection of information. Therefore, clearance by OMB under the PRA is not required. V. Electronic Access Persons with access to the internet may obtain COVID-19-related guidances at the FDA web page ``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 ``Search for FDA Guidance Documents,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or https://www.regulations.gov. Dated: May 7, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-10146 Filed 5-11-20; 8:45 am] BILLING CODE 4164-01-P