[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]
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