[Federal Register Volume 85, Number 58 (Wednesday, March 25, 2020)]
[Notices]
[Pages 16949-16950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06222]


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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, FDA-2020-D-1140, FDA-2020-D-1141, FDA-2020-D-1142, and 
FDA-2020-D-1143]


Process for Making Available Guidance Documents Related to 
Coronavirus Disease 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the process for making available FDA guidance documents related to the 
Coronavirus Disease 2019 (COVID-19) public health emergency. FDA 
believes that this process will allow the Agency to rapidly disseminate 
essential Agency recommendations and policies related to COVID-19 to 
industry, FDA staff, and other stakeholders.

FOR FURTHER INFORMATION CONTACT: 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; Stephen Ripley, Center for Biologics Evaluation and Research, 
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, 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, CPK1 Rm. 1C001, College Park, 
MD 20740, 240-402-2112; Diane Heinz, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., MPN2 RME435, HFV-6, 
Rockville, MD 20855, 240-402-5692; May Nelson, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
75, Rm. 4420, Silver Spring, MD 20993-0002, 301-796-9241; John Weiner, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5130; Silver Spring, MD 20993-0002, 301-
796-8941; or Erik Mettler, Office of Regulatory Affairs, Food and Drug 
Administration, 12420 Parklawn Dr., ELEM Rm. 3008, Rockville, MD 20857, 
301-796-9254.

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. 
247), determined that a public health emergency 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\ 
FDA is committed to providing timely recommendations, regulatory 
advice, guidance, and technical assistance on an Agency-wide basis on 
issues related to COVID-19, including to clarify our expectations 
regarding regulatory requirements to support response efforts to this 
emergency. To this end, FDA is announcing procedures for making 
available FDA guidance documents related to the COVID-19 public health 
emergency. FDA believes that these procedures, which operate within 
FDA's established good guidance practices regulations, will allow the 
Agency to rapidly disseminate Agency recommendations and policies 
related to COVID-19 to industry, FDA staff, and other stakeholders.
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    \1\ Determination that a Public Health Emergency Exists (January 
31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.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/.
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II. Procedures for Making COVID-19-Related Guidance Documents Available

    To facilitate issuance of guidance on topics related to the COVID-
19 public health emergency, the Agency intends to use the following 
procedures:
     In light of the need to act quickly and efficiently to 
respond to the COVID-19 public health emergency, FDA anticipates that 
prior public participation will not be feasible or appropriate before 
FDA implements COVID-19-related guidance documents. FDA anticipates it 
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 (21 U.S.C. 371(h)(1)(C)) 
and 21 CFR 10.115(g)(2) (Sec.  10.115(g)(2)).
     Although FDA expects that COVID-19-related guidances will 
be implemented without prior comment, FDA will solicit comment, review 
all comments received, and revise the guidance documents as appropriate 
(see Sec.  10.115(g)(2)). Each guidance will specify the docket 
number(s) to which comments can be submitted.
     Guidance documents related to COVID-19 will be accessible 
on the internet from the FDA web page entitled ``Coronavirus Disease 
2019 (COVID-19),'' available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19.
     Guidance documents related to COVID-19 may also be 
accessed from the FDA web page entitled ``Search for FDA Guidance 
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
     Rather than publishing a separate Notice of Availability 
(NOA) for each COVID-19-related guidance document, FDA intends to 
publish periodically a consolidated NOA. This periodic NOA will 
announce the availability of all the COVID-19-related guidance 
documents that issued during the relevant period. The consolidated NOA 
will provide instructions to the public on submitting comments on 
COVID-19-related guidance documents, including the docket number(s) 
associated with each guidance document, information on how to view the 
dockets, and instructions for persons interested in obtaining a copy of 
a COVID-19-related guidance document. In addition, the guidance 
document will provide information to the public on submitting comments 
on the guidance document, including the docket number(s) associated 
with the guidance document and instructions for persons interested in 
obtaining a copy of a COVID-19-related guidance document.
     FDA intends to establish one docket for each Center or 
Office that may issue

[[Page 16950]]

COVID-19-related guidance documents. All COVID-19-related guidance 
documents issued by that Center or Office will be available in the 
docket associated with the Center or Office that issues the guidance 
document. The docket numbers associated with each Center or Office that 
may issue COVID-19-related guidance documents are as follows:

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 Title of Docket (for each Center or
               Office)                             Docket No.
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Center for Drug Evaluation and         FDA-2020-D-1136
 Research (CDER) COVID-19.
Center for Biologics Evaluation and    FDA-2020-D-1137
 Research (CBER) COVID-19.
Center for Devices and Radiological    FDA-2020-D-1138
 Health (CDRH) COVID-19.
Center for Food Safety and Applied     FDA-2020-D-1139
 Nutrition (CFSAN) COVID-19.
Center for Veterinary Medicine (CVM)   FDA-2020-D-1140
 COVID-19.
Center for Tobacco Products (CTP)      FDA-2020-D-1141
 COVID-19.
Office of the Commissioner (OC) COVID- FDA-2020-D-1142
 19.
Office of Regulatory Affairs (ORA)     FDA-2020-D-1143
 COVID-19.
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    Dated: March 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06222 Filed 3-20-20; 11:15 am]
 BILLING CODE 4164-01-P