Guidance Documents Related to Coronavirus Disease 2019; Availability, 55620-55623 [2021-21798]
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
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-201509-18/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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
jspears on DSK121TN23PROD with NOTICES1
Susan Storey, Center for Veterinary
Medicine (HFV–131), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0578,
susan.storey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 15,
2020 (85 FR 42879), FDA published the
notice of availability for a draft guidance
entitled ‘‘Biomarkers and Surrogate
Endpoints in Clinical Studies to
Support Effectiveness of New Animal
Drugs,’’ giving interested persons until
October 13, 2020, to comment on the
draft guidance. This final guidance
describes how the Center for Veterinary
Medicine (CVM) intends to evaluate
biomarkers, including surrogate
endpoints, when they are incorporated
into clinical investigations submitted to
CVM to demonstrate substantial
evidence of effectiveness for new animal
drug applications or a reasonable
expectation of effectiveness for
applications for conditional approval of
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a new animal drug. It also describes
how sponsors may obtain feedback from
CVM on technical issues related to the
use of biomarkers before the submission
of an application.
FDA received comments on the draft
guidance and those comments were
considered as the guidance was
finalized. For example, we received a
comment suggesting that we remove
from the guidance discussion of
biomarkers and a new animal drug’s
mechanism of action (MOA) with the
thought that the MOA is not a primary
endpoint and is, therefore, out of the
scope of the guidance. We revised this
section of the final guidance by adding
examples of when consideration of a
new animal drug’s MOA may be
relevant for purposes of evaluating the
use of biomarkers. We also made other
editorial changes to this final guidance
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated July 2020.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Biomarkers and
Surrogate Endpoints in Clinical Studies
to Support Effectiveness of New Animal
Drugs.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. 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 this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in FDA’s guidance entitled
‘‘Biomarkers and Surrogate Endpoints in
Clinical Studies to Support
Effectiveness of New Animal Drugs’’
have been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
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Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21688 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1136 and FDA–
2020–D–1138]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
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.
FDA is also announcing the withdrawal
of two FDA guidance documents related
to the COVID–19 PHE.
DATES: The announcement of the
guidances is published in the Federal
Register on October 6, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
jspears on DSK121TN23PROD with NOTICES1
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
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‘‘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-201509-18/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, 240–402–7500.
You may submit comments on any
guidance at any time (see § 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 selfaddressed 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:
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
1 Secretary of Health and Human Services,
‘‘Determination that a Public Health Emergency
Exists Nationwide as the Result of the 2019 Novel
Coronavirus’’ (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
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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-202003-25/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
§ 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/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders) and ‘‘Search for FDA
Guidance Documents’’ (available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments).
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–19related guidances that are posted on
FDA’s website.
Disease (COVID–19) Outbreak (March 13, 2020),
available at: https://trumpwhitehouse.archives.gov/
presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-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-nationalemergency-concerning-the-coronavirus-disease2019-covid-19-pandemic.
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
II. Availability of COVID–19-Related
Guidance Documents
announcing the availability of the
following COVID–19-related guidances:
Pursuant to the process described in
the March 25, 2020, notice, FDA is
TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY
Docket No.
Center
Title of guidance
FDA–2020–
D–1136.
CDER ......
FDA–2020–
D–1138.
CDRH ......
Development of Abbreviated New Drug Applications
During the COVID–19 Pandemic—Questions and Answers; Guidance for Industry (Updated September
2021).
Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID–19)
Public Health Emergency (Updated September 2021).
Although these guidances have been
implemented immediately without prior
comment, FDA will consider all
comments received and revise the
guidances as appropriate (see
§ 10.115(g)(3)).
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidances represent the current thinking
of FDA. They do not establish any rights
for any person and are not binding on
Contact information to request single copies
druginfo@fda.hhs.gov. Please include the docket number FDA–2020–D–1136 and complete title of the
guidance in the request.
CDRH-Guidance@fda.hhs.gov. Please include the document number 20018 and complete title of the guidance in the request.
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 Guidance
While this guidance contains no
collection of information, it does 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 this guidance. 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—CDER GUIDANCES AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance title referenced in COVID–19 guidance
OMB control No(s).
Development of Abbreviated
New Drug Applications During
the COVID–19 Pandemic—
Questions and Answers;
Guidance for Industry (Updated September 2021).
21 CFR 211.170, 21 CFR
314.3, 21 CFR 314.50, 21
CFR 314.94, 21 CFR
314.101, 21 CFR 314.105,
21 CFR 314.107, 21 CFR
320.25, 21 CFR 320.31, 21
CFR 320.38, 21 CFR 320.63.
(1) ANDAs: Stability Testing of Drug Substances and Products,
Questions and Answers.
(2) Referencing Approved Drug Products in ANDA Submissions.
(3) Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID–19 Public
Health Emergency.
(4) Safety Reporting Requirements for INDs and BA/BE Studies.
(5) Controlled Correspondence Related to Generic Drug Development.
(6) Formal Meetings Between FDA and ANDA Applicants of
Complex Products Under GDUFA.
(5) Controlled Correspondence Related to Generic Drug Development.
(7) Conduct of Clinical Trials of Medical Products during the
COVID–19 Pandemic.
(8) ANDAs: Stability Testing of Drug Substances and Products,
Questions and Answers.
(9) Manufacturing, Supply Chain, and Drug and Biological
Product Inspections During COVID–19 Public Health Emergency Questions and Answers.
0910–0001, 0910–0014, 0910–
0119, 0910–0139, 0910–
0338, 0910–0581, 0910–
0672, 0910–0733, 0910–
0797.
B. CDRH Guidance
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While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information (listed in table 3).
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Therefore, clearance by OMB under the
PRA (44 U.S.C. 3501–3521) is not
required for this guidance. The
previously approved collections of
information are subject to review by
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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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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
55623
TABLE 3—CDRH GUIDANCES AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance title referenced in
COVID–19 guidance
Enforcement Policy for Face Masks and Respirators
During the Coronavirus Disease (COVID–19) Public
Health Emergency (Revised); Guidance for Industry
and Food and Drug Administration Staff.
800, 801, and 809 .............
803 .....................................
806 .....................................
807, subpart E ...................
807, subparts A through D
820 .....................................
830 and 801.20 .................
Emergency Use Authorization of Medical
Products and Related Authorities;
Guidance for Industry and Other
Stakeholders.
IV. Withdrawn COVID–19-Related
Guidance Documents
On June 30, 2021, FDA announced the
revocation of the Emergency Use
Authorizations (EUAs) for
Decontamination and Bioburden
Reduction Systems for Personal
Protective Equipment. The full text of
the revocations are available
electronically at https://
www.regulations.gov (Docket No. FDA–
2021–N–0762) and https://www.fda.gov/
medical-devices/emergency-useauthorizations-medical-devices/
historical-information-about-device-
OMB control
No(s).
0910–0485
0910–0437
0910–0359
0910–0120
0910–0625
0910–0073
0910–0720
0910–0595
emergency-use-authorizations. With the
revocation of these EUAs, on June 30,
2021, FDA also withdrew two related
decontamination and bioburden
reduction guidance documents (listed in
table 4), as the documents no longer
represent the Agency’s current thinking.
TABLE 4—WITHDRAWN GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY
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Docket No.
Title of withdrawn guidance
Withdrawal
date
Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden
Reduction Systems for Face Masks and Respirators During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency; Guidance for Industry and Food and Drug
Administration Staff.
Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support SingleUser Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease
(2019) Public Health Emergency.
June 30, 2021.
Center
FDA–2020–D–1138 .......
CDRH
FDA–2020–D–1138 .......
CDRH
These withdrawn guidance
documents are presented on FDA’s
website, for historical purposes only, at
https://www.fda.gov/medical-devices/
guidance-documents-medical-devicesand-radiation-emitting-products/
withdrawn-guidance.
Dated: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
V. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
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[FR Doc. 2021–21798 Filed 10–5–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2020–D–1400]
Use of Real-World Data and Real-World
Evidence To Support Effectiveness of
New Animal Drugs; Guidance for
Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry (GFI) #266
entitled ‘‘Use of Real-World Data and
Real-World Evidence to Support
Effectiveness of New Animal Drugs.’’
SUMMARY:
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June 30, 2021.
The guidance describes FDA’s current
thinking with respect to assisting
sponsors in incorporating real-world
data and real-world evidence (including
ongoing surveillance activities,
observational studies, and registry data)
into proposed clinical investigation
protocols and applications for new
animal drugs under the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
DATES: The announcement of the
guidance is published in the Federal
Register on October 6, 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
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]]>Agencies
[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55620-55623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21798]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1138]
Guidance Documents Related to Coronavirus Disease 2019;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
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. FDA is also announcing the withdrawal of two FDA guidance
documents related to the COVID-19 PHE.
DATES: The announcement of the guidances is published in the Federal
Register on October 6, 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
[[Page 55621]]
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.
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: 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\
---------------------------------------------------------------------------
\1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists Nationwide as the Result of the
2019 Novel Coronavirus'' (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.
---------------------------------------------------------------------------
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.
[[Page 55622]]
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
----------------------------------------------------------------------------------------------------------------
Contact information to
Docket No. Center Title of guidance request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1136........... CDER.................. Development of Abbreviated [email protected]. Please
New Drug Applications During include the docket number
the COVID-19 Pandemic-- FDA-2020-D-1136 and complete
Questions and Answers; title of the guidance in the
Guidance for Industry request.
(Updated September 2021).
FDA-2020-D-1138........... CDRH.................. Enforcement Policy for Face [email protected].
Masks, Barrier Face Please include the document
Coverings, Face Shields, number 20018 and complete
Surgical Masks, and title of the guidance in the
Respirators During the request.
Coronavirus Disease (COVID-
19) Public Health Emergency
(Updated September 2021).
----------------------------------------------------------------------------------------------------------------
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. CDER Guidance
While this guidance contains no collection of information, it does
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 this guidance. 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--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control No(s).
COVID-19 guidance guidance
----------------------------------------------------------------------------------------------------------------
Development of Abbreviated New Drug 21 CFR 211.170, 21 CFR (1) ANDAs: Stability 0910-0001, 0910-0014,
Applications During the COVID-19 314.3, 21 CFR 314.50, Testing of Drug Substances 0910-0119, 0910-0139,
Pandemic--Questions and Answers; 21 CFR 314.94, 21 CFR and Products, Questions 0910-0338, 0910-0581,
Guidance for Industry (Updated 314.101, 21 CFR and Answers. 0910-0672, 0910-0733,
September 2021). 314.105, 21 CFR (2) Referencing Approved 0910-0797.
314.107, 21 CFR Drug Products in ANDA
320.25, 21 CFR Submissions.
320.31, 21 CFR (3) Protecting Participants
320.38, 21 CFR 320.63. in Bioequivalence Studies
for Abbreviated New Drug
Applications During the
COVID-19 Public Health
Emergency.
(4) Safety Reporting
Requirements for INDs and
BA/BE Studies.
(5) Controlled
Correspondence Related to
Generic Drug Development.
(6) Formal Meetings Between
FDA and ANDA Applicants of
Complex Products Under
GDUFA.
(5) Controlled
Correspondence Related to
Generic Drug Development.
(7) Conduct of Clinical
Trials of Medical Products
during the COVID-19
Pandemic.
(8) ANDAs: Stability
Testing of Drug Substances
and Products, Questions
and Answers.
(9) Manufacturing, Supply
Chain, and Drug and
Biological Product
Inspections During COVID-
19 Public Health Emergency
Questions and Answers.
----------------------------------------------------------------------------------------------------------------
B. CDRH Guidance
While this guidance contains no collection of information, it does
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 this guidance. 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
guidance have been approved by OMB as listed in the following table:
[[Page 55623]]
Table 3--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Face Masks and 800, 801, and 809......... 0910-0485
Respirators During the Coronavirus 803....................... 0910-0437
Disease (COVID-19) Public Health 806....................... 0910-0359
Emergency (Revised); Guidance for 807, subpart E............ 0910-0120
Industry and Food and Drug
Administration Staff.
807, subparts A through D. 0910-0625
820....................... 0910-0073
830 and 801.20............ 0910-0720
Emergency Use 0910-0595
Authorization of Medical
Products and Related
Authorities; Guidance for
Industry and Other
Stakeholders.
----------------------------------------------------------------------------------------------------------------
IV. Withdrawn COVID-19-Related Guidance Documents
On June 30, 2021, FDA announced the revocation of the Emergency Use
Authorizations (EUAs) for Decontamination and Bioburden Reduction
Systems for Personal Protective Equipment. The full text of the
revocations are available electronically at https://www.regulations.gov
(Docket No. FDA-2021-N-0762) and https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations. With the revocation of these
EUAs, on June 30, 2021, FDA also withdrew two related decontamination
and bioburden reduction guidance documents (listed in table 4), as the
documents no longer represent the Agency's current thinking.
Table 4--Withdrawn Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
Docket No. Center Title of withdrawn guidance Withdrawal date
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1138..................... CDRH Recommendations for Sponsors June 30, 2021.
Requesting EUAs for
Decontamination and Bioburden
Reduction Systems for Face Masks
and Respirators During the
Coronavirus Disease 2019 (COVID-
19) Public Health Emergency;
Guidance for Industry and Food and
Drug Administration Staff.
FDA-2020-D-1138..................... CDRH Enforcement Policy for Bioburden June 30, 2021.
Reduction Systems Using Dry Heat
to Support Single-User Reuse of
Certain Filtering Facepiece
Respirators During the Coronavirus
Disease (2019) Public Health
Emergency.
----------------------------------------------------------------------------------------------------------------
These withdrawn guidance documents are presented on FDA's website,
for historical purposes only, at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-guidance.
V. 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: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21798 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P
