Guidance Documents Related to Coronavirus Disease 2019; Availability, 28627-28630 [2021-11217]
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
28627
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RADM Denise M. Hinton
ChiefScientist
Food-.and Drug·,Attministtatiro.
Enclosures
[FR Doc. 2021–11234 Filed 5–26–21; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1136]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
SUMMARY:
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
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.
The announcement of the
guidances is published in the Federal
Register on May 27, 2021.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
PO 00000
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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.
E:\FR\FM\27MYN1.SGM
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EN27MY21.018</GPH>
Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
28628
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
• 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
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
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. 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.
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’’ (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-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. On February 24, 2021,
PO 00000
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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.
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.
E:\FR\FM\27MYN1.SGM
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
II. Availability of COVID–19-Related
Guidance Documents
28629
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–1136 ........
CDER
Development of Abbreviated New Drug Applications
During the COVID–19 Pandemic—Questions and
Answers Guidance for Industry (April 2021).
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During
the COVID–19 Public Health Emergency Guidance for Industry (April 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
Contact information to request single copies
druginfo@fda.hhs.gov. Please include the
number FDA–2020–D–1136 and complete
the guidance in the request.
druginfo@fda.hhs.gov. Please include the
number FDA–2020–D–1136 and complete
the guidance in the request.
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
CDER Guidances
While these guidances contain no
collection of information, they do refer
to previously approved FDA collections
docket
title of
docket
title of
of information (listed in table 2).
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:
jbell on DSKJLSW7X2PROD with NOTICES
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
Development of Abbreviated New
Drug Applications During the
COVID–19 Pandemic—Questions and Answers Guidance
for Industry (April 2021).
....................................................
Remote Interactive Evaluations of
Drug Manufacturing and Bioresearch Monitoring Facilities
During the COVID–19 Public
Health Emergency Guidance
for Industry (April 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.
—Manufacturing, Supply Chain, and Drug and
Biological Product Inspections During COVID–
19 Public Health Emergency Questions and
Answers.
—Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.
—ANDAs: Stability Testing of Drug Substances
and Products, Questions and Answers.
—Referencing Approved Drug Products in ANDA
Submissions.
—Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications
During the COVID–19 Public Health Emergency.
—Safety Reporting Requirements for INDs and
BA/BE Studies.
—Controlled Correspondence Related to Generic Drug Development.
—Formal Meetings Between FDA and ANDA
Applicants of Complex Products Under
GDUFA.
—Conduct of Clinical Trials of Medical Products
During the COVID–19 Pandemic.
—ANDAs: Stability Testing of Drug Substances
and Products.
—ANDAs: Stability Testing of Drug Substances
and Products, Questions and Answers.
IV. Electronic Access
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
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17:29 May 26, 2021
Jkt 253001
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
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OMB control No(s).
0910–0001, 0910–
0338, 0910–0139.
0910–0001, 0910–
0014, 0910–0797,
0910–0119 0910–
0581, 0910–0733,
0910–0672.
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
E:\FR\FM\27MYN1.SGM
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28630
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–11217 Filed 5–26–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0027]
Procedures for Handling PostApproval Studies Imposed by
Premarket Approval Application Order;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Procedures for
Handling Post-Approval Studies
Imposed by Premarket Approval
Application Order.’’ The existing postapproval studies final guidance, entitled
‘‘Procedures for Handling Post-Approval
Studies Imposed by PMA Order,’’ was
issued in June 2009. This draft guidance
is intended to update the 2009 guidance
to assist stakeholders with
understanding post-approval study
requirements imposed as a condition of
approval of a premarket approval
application (PMA). This draft guidance
is not final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by July 26, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
jbell on DSKJLSW7X2PROD with NOTICES
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
anyone else’s Social Security number, or
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
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 Docket No. FDA–
2005–D–0027 for ‘‘Procedures for
Handling Post-Approval Studies
Imposed by Premarket Approval
Application Order.’’ Received
comments will be placed in the docket
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
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
‘‘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)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Procedures for
Handling Post-Approval Studies
Imposed by Premarket Approval
Application Order’’ to the Office of
Policy, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Nilsa Loyo-Berrios, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G114, Silver Spring,
MD 20993–0002, 301–796–6065.
SUPPLEMENTARY INFORMATION:
I. Background
To provide reasonable assurance, or
the continued assurance, of safety and
effectiveness of an approved device,
FDA may require a post-approval study
(PAS) as a condition of approval under
21 CFR 814.82(a)(2) and (a)(9). A PAS is
usually a clinical or non-clinical study,
as specified in the PMA approval order,
and is typically intended to gather
specific data to address questions about
the postmarket performance of or
experience with an approved medical
device. As described in ‘‘Balancing
Premarket and Postmarket Data
Collection for Devices Subject to
Premarket Approval,’’ FDA may
E:\FR\FM\27MYN1.SGM
27MYN1
]]>Agencies
[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28627-28630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11217]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1136]
Guidance Documents Related to Coronavirus Disease 2019;
Availability
AGENCY: Food and Drug Administration, 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.
DATES: The announcement of the guidances is published in the Federal
Register on May 27, 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.
[[Page 28628]]
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. 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.
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.
[[Page 28629]]
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 [email protected].
Abbreviated New Drug Please include the
Applications During the docket number FDA-2020-
COVID-19 Pandemic-- D-1136 and complete
Questions and Answers title of the guidance
Guidance for Industry in the request.
(April 2021).
FDA-2020-D-1136......................... CDER Remote Interactive [email protected].
Evaluations of Drug Please include the
Manufacturing and docket number FDA-2020-
Bioresearch Monitoring D-1136 and complete
Facilities During the title of the guidance
COVID-19 Public Health in the request.
Emergency Guidance for
Industry (April 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
CDER 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 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 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 ....................... --Manufacturing, Supply 0910-0001, 0910-0338,
Applications During the COVID-19 Chain, and Drug and 0910-0139.
Pandemic--Questions and Answers Biological Product
Guidance for Industry (April 2021). Inspections During
COVID-19 Public Health
Emergency Questions
and Answers.
--Circumstances that
Constitute Delaying,
Denying, Limiting, or
Refusing a Drug
Inspection..
Remote Interactive Evaluations of 21 CFR 211.170, 21 CFR --ANDAs: Stability 0910-0001, 0910-0014,
Drug Manufacturing and Bioresearch 314.3, 21 CFR 314.50, Testing of Drug 0910-0797, 0910-0119
Monitoring Facilities During the 21 CFR 314.94, 21 CFR Substances and 0910-0581, 0910-0733,
COVID-19 Public Health Emergency 314.101, 21 CFR Products, Questions 0910-0672.
Guidance for Industry (April 2021). 314.105, 21 CFR and Answers.
314.107, 21 CFR --Referencing Approved
320.25, 21 CFR 320.31, Drug Products in ANDA
21 CFR 320.38, 21 CFR Submissions..
320.63. --Protecting
Participants in
Bioequivalence Studies
for Abbreviated New
Drug Applications
During the COVID-19
Public Health
Emergency..
--Safety Reporting
Requirements for INDs
and BA/BE Studies..
--Controlled
Correspondence Related
to Generic Drug
Development..
--Formal Meetings
Between FDA and ANDA
Applicants of Complex
Products Under GDUFA..
--Conduct of Clinical
Trials of Medical
Products During the
COVID-19 Pandemic..
--ANDAs: Stability
Testing of Drug
Substances and
Products..
--ANDAs: Stability
Testing of Drug
Substances and
Products, Questions
and Answers..
----------------------------------------------------------------------------------------------------------------
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.
[[Page 28630]]
Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11217 Filed 5-26-21; 8:45 am]
BILLING CODE 4164-01-P
