[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46641-46646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16852]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1137, FDA-
2020-D-1138, FDA-2020-D-1139, and FDA-2020-D-1140]
Guidance Documents Related to Coronavirus Disease 2019;
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 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 August 3, 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:
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
[[Page 46642]]
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 21 CFR
10.115(g)(5)). Submit written requests for single copies of these
guidances to the address 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. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; 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; Erica Takai,
Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, HFZ-450,
Silver Spring, MD 20993-0002, 301-796-6353; 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; Diane Heinz,
Center for Veterinary Medicine (CVM), Food and Drug Administration,
MPN2 RME435 HFV-6, 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, pursuant to the
authority under section 319 of the Public Health Service Act (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; on July 23, 2020, it was extended again,
effective July 25, 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 (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 21 CFR 10.115(g)(2) (Sec.
10.115(g)(2))). The guidances are available at FDA's web page titled
``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 titled
``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
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidance
documents that 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 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:
[[Page 46643]]
Table 1--Guidance Related to the COVID-19 Public Health Emergency
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Contact information to
Docket No. Center Title of guidance request single copies
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FDA-2020-D-1106................... CDER................. Temporary Policy for [email protected].
Preparation of Certain Please include the
Alcohol-Based Hand docket number FDA-2020-D-
Sanitizer Products During 1106 and complete title
the Public Health of the guidance in the
Emergency (COVID-19) request.
(March 2020) (Updated
June 1, 2020).
FDA-2020-D-1106................... CDER................. Policy for Temporary [email protected].
Compounding of Certain Please include the
Alcohol-Based Hand docket number FDA-2020-D-
Sanitizer Products During 1106 and complete title
the Public Health of the guidance in the
Emergency (March 2020) request.
(Updated June 1, 2020).
FDA-2020-D-1106................... CDER................. Temporary Policy for [email protected].
Manufacture of Alcohol Please include the
for Incorporation Into docket number FDA-2020-D-
Alcohol-Based Hand 1106 and complete title
Sanitizer Products During of the guidance in the
the Public Health request.
Emergency (COVID-19)
(March 2020) (Updated
June 1, 2020).
FDA-2020-D-1136................... CDER................. Temporary Policy on [email protected].
Prescription Drug Please include the
Marketing Act docket number FDA-2020-D-
Requirements for 1136 and complete title
Distribution of Drug of the guidance in the
Samples During the COVID- request.
19 Public Health
Emergency (June 8, 2020).
FDA-2020-D-1136................... CDER................. Statistical Considerations [email protected].
CBER, CDRH, CVM...... for Clinical Trials Please include the
During the COVID-19 docket number FDA-2020-D-
Public Health Emergency 1136 and complete title
Guidance for Industry of the guidance in the
(June 2020). request.
FDA-2020-D-1136................... CDER, CVM, CBER...... Good Manufacturing [email protected].
Practice Considerations Please include the
for Responding to COVID- docket number FDA-2020-D-
19 Infection in Employees 1136 and complete title
in Drug and Biological of the guidance in the
Products Manufacturing request.
(June 2020).
FDA-2020-D-1137................... CBER................. Development and Licensure Office of Communication,
of Vaccines to Prevent Outreach and
COVID-19 (June 2020). Development, 10903 New
Hampshire Ave., Bldg.
71, Rm. 3128, Silver
Spring, MD 20993-0002.
Phone 1-800-835-4709 or
240-402-8010, email
[email protected].
FDA-2020-D-1138................... CDRH................. Enforcement Policy for Non- CDRH-
Invasive Remote [email protected].
Monitoring Devices Used Please include the
to Support Patient document number 20014
Monitoring During the and complete title of
Coronavirus Disease 2019 the guidance in the
(COVID-19) Public Health request.
Emergency (Revised)
(March 20, 2020) (Updated
June 5, 2020).
FDA-2020-D-1138................... CDRH................. Notifying CDRH of a CDRH-
Permanent Discontinuance [email protected].
or Interruption in Please include the
Manufacturing of a Device document number 20032
Under Section 506J of the and complete title of
FD&C Act During the COVID- the guidance in the
19 Public Health request.
Emergency (May 6, 2020)
(Updated June 19, 2020).
FDA-2020-D-1138................... CDRH, CBER........... Effects of the COVID-19 CDRH-
Public Health Emergency [email protected].
on Formal Meetings and Please include the
User Fee Applications for document number 20040
Medical Devices-- and complete title of
Questions and Answers the guidance in the
(June 2020). request.
FDA-2020-D-1139................... CFSAN................ Reporting a Temporary INFOCenter-
Closure or Significantly [email protected].
Reduced Production by a Please include the
Human Food Establishment docket number, FDA-2020-
and Requesting FDA D-1139, and complete
Assistance During the title of the guidance in
COVID-19 Public Health the request.
Emergency (May 27, 2020).
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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)).
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. CDER Guidances
The guidances listed in the table below refer 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 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:
[[Page 46644]]
Table 2--CDER Guidances and Collections
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Another guidance
COVID-19 guidance title CFR cite referenced referenced in COVID-19 OMB Control No(s).
in COVID-19 guidance guidance
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Good Manufacturing Practice 21 CFR 211, 211.22, (1) ICH Q7 Good 0910-0130
Considerations for Responding to 211.28(d), 211.100. Manufacturing Practice 0910-0139
COVID-19 Infections in Employees 21 CFR 212.20, Guidance for Active 0910-0667
in Drug and Biological Products 212.30, 212.50, Pharmaceutical 0910-0675
Manufacturing--June 2020. 212.70, 212.71. Ingredients. 0910-0759
21 CFR 600.10(c)(1).. (2) ICH Q5A Viral Safety 0910-0032
Evaluation of 0910-0669
biotechnology Products
Derived From Cell Lines
of Human or Animal Origin.
(3) ICH Q9 Quality Risk
Management.
(4) Planning for the
Effects of High
Absenteeism to Ensure
Availability of Medically
Necessary Drug Products.
(5) Enforcement Policy for
Sterilizers, disinfectant
Devices, and Air
Purifiers During the
Coronavirus Disease 2019
(COVID-19) Public Health
Emergency..
(6) 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..
(7) GFI #271 Reporting and
Mitigating Animal Drug
Shortages during the
COVID-19 Public Health
Emergency..
Temporary Policy on Prescription 21 CFR 203........... .......................... 0910-0435
Drug Marketing Act Requirements
for Distribution of Drug Samples
during the COVID-19 Public Health
Emergency--Guidance for Industry.
Temporary Policy for Preparation of 27 CFR Part 20 and 21 (1) Temporary Compounding 0910-0045
Certain Alcohol-Based Hand of Certain Alcohol-Based 0910-0139
Sanitizer Products During the Hand Sanitizer Products 0910-0230
Public Health Emergency (COVID- During the Public Health 0910-0291
19)--UPDATE of guidance announced Emergency (COVID-19). 0910-0340
in March 2020. (2) Temporary Policy for 0910-0641
Manufacture of Alcohol 0910-0645
for Incorporation Into 0910-0800
Alcohol-Based Hand
Sanitizer Products During
the Public Health
Emergency (COVID-19).
(3) Adverse Event
Reporting Requirements.
Temporary Policy for Manufacture of 27 CFR Part 20 and 21 None...................... 0910-0045
Alcohol for Incorporation Into 0910-0139
Alcohol-Based Hand Sanitizer 0910-0230
Products During the Public Health 0910-0291
Emergency (COVID-19)--UPDATE of 0910-0340
guidance announced in March 2020. 0910-0641
0910-0645
0910-0800
Policy for Temporary Compounding of ..................... (1) Temporary Policy for 0910-0045
Certain Alcohol-Based Hand Preparation of Certain 0910-0139
Sanitizer Products During the Alcohol-Based Hand 0910-0230
Public Health Emergency Sanitizer Products During 0910-0291
Immediately in Effect Guidance for the Public Health 0910-0340
Industry--UPDATE of guidance Emergency (COVID-19). 0910-0641
announced in March 2020. (2) Temporary Policy for 0910-0645
Manufacture of Alcohol 0910-0800
for Incorporation into
Alcohol-Based Hand
Sanitizer Products During
the Public Health
Emergency (COVID-19).
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The guidance, Statistical Considerations for Clinical Trials during
the COVID-19 Public Health Emergency, contains no collection of
information. Therefore, clearance by OMB under the PRA is not required.
B. CBER Guidances
The guidance listed in the table below refer to previously approved
collection of information. This collection of information is subject to
review by the OMB under the PRA. The collection of information in the
following FDA regulations and guidance have been approved by OMB as
listed in the following table:
[[Page 46645]]
Table 3--CBER Guidances and Collections
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Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID- OMB Control No(s).
COVID-19 guidance 19 guidance
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Development and Licensure of 21 CFR part 312........ ...................... 0910-0114
Vaccines to Prevent COVID-19. 21 CFR part 58......... ...................... 0910-0119
21 CFR part 50......... ...................... 0910-0130
21 CFR parts 210, 211, ...................... 0910-0139
and 610.
221 CFR part 600....... ...................... 0910-0308
221 CFR part 601....... ...................... 0910-0338
--Form FDA 3500A...... 0910-0291
--Establishment and 0910-0581
Operation of Clinical 0910-0595
Trial Data Monitoring
Committees.
--Emergency Use
Authorization of
Medical Products and
Related Authorities.
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C. CDRH Guidances
The guidances listed in the table 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:
Table 4--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID- OMB Control No(s).
COVID-19 guidance 19 guidance
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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
(Revised) (March 20, 2020) (Updated
June 5, 2020).
Effects of the COVID-19 Public ....................... Requests for Feedback 0910-0756
Health Emergency on Formal Meetings and Meetings for
and User Fee Applications for Medical Device
Medical Devices--Questions and Submissions: The Q-
Answers (June 22, 2020). Submission Program:
Guidance for Industry
and Food and Drug
Administration Staff.
Emergency Use 0910-0595
Authorization of
Medical Products and
Related Authorities;
Guidance for Industry
and Other
Stakeholders.
814, subparts A through ...................... 0910-0231
E.
807, subpart E......... ...................... 0910-0120
De Novo Classification 0910-0844
Process (Evaluation
of Automatic Class
III Designation):
Guidance for Industry
and Food and Drug
Administration Staff.
814, subpart H......... ...................... 0910-0332
812.................... ...................... 0910-0078
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The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the 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. 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 the Department of Health and Human Services (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 46646]]
Table 5--CDRH Guidances and Collections
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CFR cite Another guidance New collection
COVID-19 guidance title referenced in referenced in OMB Control No(s). covered by PHE
COVID-19 guidance COVID-19 guidance PRA waiver
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Notifying CDRH of Permanent 807, subparts A 0910-0625
Discontinuance or Interruption through D. Emergency Use 0910-0595
in Manufacturing of a Device Authorization of
Under Section 506J of the FD&C Medical Products
Act During the COVID-19 Public and Related
Health Emergency (Revised) Authorities;
(May 6, 2020) (Updated June Guidance for
19, 2020). Industry and
Other
Stakeholders.
Notifications to
FDA about
changes in the
production of
certain medical
device products
that will help
the Agency
prevent or
mitigate
shortages of
such devices
during the COVID-
19 public health
emergency.
Updates to FDA
every two weeks
after initial
notification on
the shortage
situation,
including the
expected
timeline for
recovery.
Voluntary
submission of
other
information that
enables FDA to
work more
effectively with
manufacturers
and other
entities to
prevent or limit
any negative
impact on
patients or
healthcare
providers during
the COVID-19
public health
emergency.
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D. CFSAN Guidances
The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the 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. 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 6--CFSAN Guidances and Collections
----------------------------------------------------------------------------------------------------------------
CFR cite Another guidance New Collection
COVID-19 guidance title referenced in referenced in OMB Control No(s). covered by PHE
COVID-19 guidance COVID-19 guidance PRA waiver
----------------------------------------------------------------------------------------------------------------
Reporting a Temporary Closure 21 CFR part 1, .................. 0910-0502 Establishments
or Significantly Reduced subpart H. have the option
Production by a Human Food to report to FDA
Establishment and Requesting temporary
FDA Assistance During the closures or
COVID-19 Public Health significant
Emergency. reductions of
production and
to request
assistance from
FDA.
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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: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16852 Filed 7-31-20; 8:45 am]
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