[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21744-21748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08474]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-0987, FDA-2020-D-1106, FDA-2020-D-1136, FDA-
2020-D-1137, FDA-2020-D-1825]
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 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 April 23, 2021.
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 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, 240-402-7500.
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.
[[Page 21745]]
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, 240-402-7500.
You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (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.
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, or 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.
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, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
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\1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), 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://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February
24, 2021, there was a Presidential Declaration continuing the
national emergency concerning the COVID-19 pandemic beyond March 1,
2021. See ``Continuation of the National Emergency Concerning the
Coronavirus Disease 2019 (COVID-19) Pandemic'' (February 24, 2021),
available at https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
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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 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 (21 U.S.C.
371(h)(1)(C)) and Sec. 10.115(g)(2)). The guidances are available on
FDA's web pages 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)
and ``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 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
guidances:
Table 1--Guidances 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-1825................. CBER................ Investigational COVID-19 Office of Communication,
Convalescent Plasma Outreach and Development,
(Updated February 2021). 10903 New 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-1137................. CBER................ Emergency Use Authorization Office of Communication,
for Vaccines to Prevent Outreach and Development,
COVID-19 (Updated February 10903 New Hampshire Ave.,
2021). Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002, 1-
800-835-4709 or 240-402-
8010; email
[email protected].
FDA-2020-D-1136................. CDER................ COVID-19 Container Closure [email protected].
System and Component Please include the docket
Changes: Glass Vials and number FDA-2020-D-1136 and
Stoppers Guidance for complete title of the
Industry (March 2021). guidance in the request.
FDA-2020-D-1136................. CDER................ Development of Monoclonal [email protected].
Antibody Products Please include the docket
Targeting SARS-CoV-2, number FDA-2020-D-1136 and
Including Addressing the complete title of the
Impact of Emerging guidance in the request.
Variants, During the COVID
19 Public Health Emergency
(February 2021).
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FDA-2020-D-1106................. CDER................ Temporary Policy for [email protected].
Manufacture of Alcohol for Please include the docket
Incorporation Into Alcohol- number FDA-2020-D-1106 and
Based Hand Sanitizer complete title of the
Products During the Public guidance in the request.
Health Emergency (COVID-
19) (Updated February
2021).
FDA-2020-D-1106................. CDER................ Temporary Policy for [email protected].
Preparation of Certain Please include the docket
Alcohol-Based Hand number FDA-2020-D-1106 and
Sanitizer Products During complete title of the
the Public Health guidance in the request.
Emergency (COVID-19)
(Updated February 2021).
FDA-2020-D-0987................. CDRH................ Policy for Evaluating [email protected].
Impact of Viral Mutations Please include the
on COVID-19 Tests document number 21104 and
(February 2021). complete title of the
guidance in the request.
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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 Guidances
While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for these guidances. The previously approved
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 2--CBER Guidances and Collections
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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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Emergency Use Authorization for 21 CFR 314.420........... 0910-0001
Vaccines to Prevent COVID-19 21 CFR part 312.......... ............................. 0910-0014
(Updated: February 22, 2021). 21 CFR parts 210, 211, ............................. 0910-0139
and 610. ............................. 0910-0308
21 CFR part 600.......... ............................. 0910-0338
21 CFR part 601..........
Emergency Use Authorization 0910-0595
of Medical Products and
Related Authorities.
Investigational COVID-19 Convalescent 21 CFR part 312.......... 0910-0014
Plasma; Guidance for Industry 21 CFR parts 606 and 630. ............................. 0910-0116
(Updated: February 11, 2021).
Form FDA 3926................ 0910-0814
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B. CDER Guidances
While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for these guidances. The previously approved
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 3--CDER Guidances and Collections
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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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COVID-19 Container Closure System and 21 CFR 314.70............ Requests for Expedited Review 0910-0001
Component Changes: Glass Vials and 21 CFR 314.97............ of New Drug Application and 0910-0338
Stoppers Guidance for Industry (March 21 CFR 601.12............ Biologics License 0910-0139
2021). 21 CFR 314.420........... Application Prior Approval
Supplements Submitted for
Chemistry, Manufacturing,
and Controls Changes.
Comparability Protocols for
Human Drugs and Biologics:
Chemistry, Manufacturing,
and Controls Information
(April 2016).
Chemistry, Manufacturing, and
Controls Changes to an
Approved Application:
Certain Biological Products
(December 2017).
Changes to an Approved
Application for Specified
Biotechnology and Specified
Synthetic Biological
Products (July 1997).
Changes to an Approved NDA or
ANDA (April 2004).
Container Closure Systems for
Packaging Human Drugs and
Biologics; Chemistry,
Manufacturing, and Controls
Documentation (May 1999).
CMC Postapproval
Manufacturing Changes for
Specified Biological
Products To Be Documented in
Annual Reports (August 2017).
Comparability Protocols for
Human Drugs and Biologics:
Chemistry, Manufacturing,
and Controls Information
(April 2016).
Drug Master Files (October
2019).
Harmonizing Compendial
Standards With Drug
Application Approval Using
the USP Pending Monograph
Process (July 2019).
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Manufacturing, Supply Chain,
and Drug and Biological
Product Inspections During
COVID-19 Public Health
Emergency; Questions and
Answers (August 2020).
PAC-ATLS: Postapproval
Changes--Analytical Testing
Laboratory Sites (April
1998).
Submission Documentation for
Sterilization Process
Validation in Applications
for Human and Veterinary
Drug Products (November
1994).
Immediate Release Solid Oral
Dosage Forms; Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing,
and Controls, In Vitro
Dissolution Testing, and In
Vivo Bioequivalence
Documentation (November
1995).
Nonsterile Semisolid Dosage
Forms; Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing,
and Controls; In Vitro
Release Testing and In Vivo
Bioequivalence Documentation
(May 1997).
SUPAC: Manufacturing
Equipment Addendum (December
2014).
SUPAC-IR: Questions and
Answers about SUPAC-IR
Guidance (February 1997).
SUPAC-MR: Modified Release
Solid Oral Dosage Forms;
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and Controls;
In Vitro Dissolution Testing
and In Vivo Bioequivalence
Documentation (September
1997).
Q6A Specifications: Test
Procedures and Acceptance
Criteria for New Drug
Substances and New Drug
Products: Chemical
Substances (December 2000).
Q6B Specifications: Test
Procedures and Acceptance
Criteria for
Biotechnological/Biological
Products (August 1999).
Q9 Quality Risk Management
(June 2006).
Q10 Pharmaceutical Quality
System (April 2009).
Development of Monoclonal Antibody 21 CFR 312............... Emergency Use Authorization 0910-0014
Products Targeting SARS-CoV-2, 21 CFR 601.20............ of Medical Products and 0910-0001
Including Addressing the Impact of Related Authorities (January 0910-0338
Emerging Variants, During the COVID- 2017). 0910-0139
19 Public Health Emergency (February
2021).
COVID-19: Potency Assay
Considerations for
Monoclonal Antibodies and
Other Therapeutic Proteins
Targeting SARS-CoV-2
Infectivity (January 2021).
S6(R1) Preclinical Safety
Evaluation of Biotechnology-
Delivered Pharmaceuticals
(May 2012).
CGMP for Phase 1
Investigational Drugs (July
2008)..
COVID-19 Public Health
Emergency: General
Considerations for Pre-IND
Meeting Requests for COVID-
19 Related Drugs and
Biological Products.
Points to Consider in the
Manufacture and Testing of
Monoclonal Antibody Products
for Human Use (February
1997)..
COVID-19: Developing Drugs
and Biological Products for
Treatment or Prevention
(February 2021).
Antiviral Product
Development--Conducting and
Submitting Virology Studies
to the Agency (June 2006).
Temporary Policy for Preparation of Temporary Compounding of 0910-0045
Certain Alcohol-Based Hand Sanitizer Certain Alcohol-Based Hand 0910-0139
Products During the Public Health Sanitizer Products During 0910-0230
Emergency (COVID-19) (Updated the Public Health Emergency 0910-0291
February 10, 2021). (COVID-19). 0910-0340
0910-0641
0910-0645
0910-0800
Temporary Policy for
Manufacture of Alcohol for
Incorporation Into Alcohol-
Based Hand Sanitizer
Products During the Public
Health Emergency (COVID-19).
Adverse Event Reporting
Requirements.
Policy for Testing of Alcohol
(Ethanol) and Isopropyl
Alcohol for Methanol,
Including During the Public
Health Emergency (COVID-19).
Q3C Guideline on Impurities:
Guideline for Residual
Solvents.
Temporary Policy for Manufacture of 21 CFR 207.17............ Temporary Policy for 0910-0045
Alcohol for Incorporation Into 21 CFR 207.25............ Preparation of Certain 0910-0139
Alcohol-Based Hand Sanitizer Products 21 CFR 207.41............ Alcohol-Based Hand Sanitizer 0910-0230
During the Public Health Emergency Products During the Public 0910-0291
(COVID-19) (Updated February 10, Health Emergency (COVID-19). 0910-0340
2021). 0910-0641
Policy for Testing of Alcohol
(Ethanol) and Isopropyl
Alcohol for Methanol,
Including During the Public
Health Emergency (COVID-19).
Q3C Guideline on Impurities:
Guideline for Residual
Solvents.
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C. CDRH Guidance
While this guidance contains no collection of information, it does
refer to a previously approved FDA collection of information (listed in
table 4). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collection of information is subject to review by OMB under the PRA.
The collection of information in the following FDA guidance has been
approved by OMB as listed in the following table:
[[Page 21748]]
Table 4--CDRH Guidance and Collections
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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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Policy for Evaluating Impact of Viral Emergency Use Authorization 0910-0595
Mutations on COVID-19 Tests (February of Medical Products and
2021). Related Authorities;
Guidance for Industry and
Other Stakeholders.
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IV. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at:
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;
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: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08474 Filed 4-22-21; 8:45 am]
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