Process for Making Available Guidance Documents Related to Coronavirus Disease 2019, 16949-16950 [2020-06222]

Download as PDF Federal Register / Vol. 85, No. 58 / Wednesday, March 25, 2020 / Notices and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. (Authority: Section 510 (42 U.S.C. 710), as amended by Section 50502 (Pub. L. 115– 123)) Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2020–06210 Filed 3–24–20; 8:45 am] BILLING CODE 4184–83–P 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. 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. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 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; VerDate Sep<11>2014 16:18 Mar 24, 2020 Jkt 250001 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. II. Procedures for Making COVID–19Related Guidance Documents Available To facilitate issuance of guidance on topics related to the COVID–19 public 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-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 16949 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–19related 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) (§ 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 § 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-2019covid-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/regulatoryinformation/search-fda-guidancedocuments. • 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–19related guidance document. • FDA intends to establish one docket for each Center or Office that may issue E:\FR\FM\25MRN1.SGM 25MRN1 16950 Federal Register / Vol. 85, No. 58 / Wednesday, March 25, 2020 / Notices 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: Title of Docket (for each Center or Office) Docket No. Center for Drug Evaluation and Research (CDER) COVID–19 .............................................................................................. Center for Biologics Evaluation and Research (CBER) COVID–19 ....................................................................................... Center for Devices and Radiological Health (CDRH) COVID–19 ........................................................................................... Center for Food Safety and Applied Nutrition (CFSAN) COVID–19 ....................................................................................... Center for Veterinary Medicine (CVM) COVID–19 ................................................................................................................. Center for Tobacco Products (CTP) COVID–19 ..................................................................................................................... Office of the Commissioner (OC) COVID–19 ......................................................................................................................... Office of Regulatory Affairs (ORA) COVID–19 ....................................................................................................................... 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of General Medical Sciences Special Emphasis Panel, April 3, 2020, 8:00 a.m. to April 3, 2020, 6:00 p.m., The Hyatt House, Potomac Conference Room, The Wharf, 725 Wharf Street SW, Washington, DC 20024 which was published in the Federal Register on December 19, 2019, 84 FR 69756. The meeting notice is amended to change the Meeting Format from Regular Meeting on April 3, 2020 to a Teleconference Meeting on April 3, 2020. The meeting is closed to the public. Dated: March 19, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–06203 Filed 3–24–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES khammond on DSKJM1Z7X2PROD with NOTICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Subcommittee A— Cancer Centers, May 13, 2020, 5:00 p.m. to May 14, 2020, 6:00 p.m., Embassy Suites at the Chevy Chase Pavilion, VerDate Sep<11>2014 16:18 Mar 24, 2020 Jkt 250001 4300 Military Road NW, Washington, DC 20015 which was published in the Federal Register on December 20, 2019, 84 FR 70202. This meeting notice is amended to change the meeting location, times, and format. The meeting will now be held on May 13, 2020, 9:00 a.m. to May 14, 2020, 11:30 a.m. as a Video-Assisted Meeting at National Cancer Institute (NCI) Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850. The meeting is closed to the public. Dated: March 19, 2020. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–06201 Filed 3–24–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, April 14, 2020, 08:00 a.m. to April 14, 2020, 05:00 p.m., Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), Conference Room Auburn, 8120 Wisconsin Avenue, Bethesda, MD 20814 which was published in the Federal Register on March 09, 2020, 85 FR 13667. The meeting notice is amended to change the Meeting Format from Regular Meeting on April 14, 2020 to a Teleconference Meeting on April 14, 2020. The meeting is closed to the public. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 FDA–2020–D–1143 Dated: March 19, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–06204 Filed 3–24–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Advisory Council, March 30, 2020, 8:30 a.m. to 3:00 p.m. at National Institutes of Health, 6700B Rockledge Drive, Conference Room A&B, Bethesda, MD 20817 which was published in the Federal Register on January 30, 2020, 85 FR 5459, and change in format published in the Federal Register on March 17, 2020, 85 FR 15206. The meeting will be held at National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, March 30, 2020, 1:00 p.m. to 3:00 p.m. This meeting will be held by videoconference only. URL for virtual access: https:// videocast.nih.gov. For additional information, please visit: https://public.csr.nih.gov/ AboutCSR/Organization/CSRAdvisory Council. The meeting is open to the public. Dated: March 19, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–06209 Filed 3–24–20; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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/.
---------------------------------------------------------------------------

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:

------------------------------------------------------------------------
 Title of Docket (for each Center or
               Office)                             Docket No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


    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