[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]
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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]
Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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\
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\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/.
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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
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Contact information to
Docket No. Center/office Title of guidance request single copies
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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).
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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.
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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
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Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
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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
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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:
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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
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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.
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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.
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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
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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
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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.
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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:
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Table 6--CFSAN Guidance
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Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No.
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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.
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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]
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