Guidance Documents Related to Coronavirus Disease 2019; Availability, 39048-39051 [2021-15649]
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 30, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
khammond on DSKJM1Z7X2PROD with NOTICES
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 Docket No. FDA–
2021–P–0424 for ‘‘Medical Devices;
Exemption from Premarket Notification:
Powered Patient Transport, All Other
Powered Patient Transport.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
VerDate Sep<11>2014
16:49 Jul 22, 2021
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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-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.
FOR FURTHER INFORMATION CONTACT: Dan
Reed, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1526, Silver Spring,
MD 20993–0002, 240–402–4717.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 15, 2021, FDA
published a notice with a 60-day
comment period requesting comments
by August 16, 2021. Comments on the
notice will inform FDA’s response to a
petition requesting exemption from
premarket notification requirements for
powered patient transport, all other
powered patient transport.
In the Federal Register of June 30,
2021, FDA corrected the docket number
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associated with the notice (86 FR
34770). FDA has considered the
requirements associated with receipt of
a petition requesting exemption from
premarket notification requirements
under section 510(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360(m)). Due to the correction to the
docket number, the Agency is extending
the comment period for the notice, until
August 30, 2021. The Agency believes
that an extension allows adequate time
for interested persons to submit
comments from the date of the
correction to the notice issued June 30,
2021, without delaying our
consideration of these important issues.
Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–15646 Filed 7–22–21; 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–1137]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
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
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.
SUMMARY:
The announcement of the
guidances is published in the Federal
Register on July 23, 2021.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:49 Jul 22, 2021
Jkt 253001
‘‘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-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 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 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.
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, pursuant to the
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39049
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
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/regulatory1 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,
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. 139 / Friday, July 23, 2021 / Notices
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.
information/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
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
Docket No.
Center
Title of guidance
Contact information to request single copies
FDA–2020–D–1136 ........
CDER ...........
druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1136 and complete title
of the guidance in the request.
FDA–2020–D–1137 ........
CBER ...........
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID–19
Public Health Emergency Questions and Answers (Updated May 2021).
Emergency Use Authorization for Vaccines to
Prevent COVID–19 (Updated May 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
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).
Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–0002, 1–
800–835–4709 or 240–402–8010; email
ocod@fda.hhs.gov.
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
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Manufacturing, Supply Chain,
and Drug and Biological
Product Inspections During
COVID–19 Public Health
Emergency Questions and
Answers (Updated May
2021).
VerDate Sep<11>2014
16:49 Jul 22, 2021
CFR cite
referenced in COVID–19
guidance
21 CFR 314.50, 314.94,
314.95, 314.125, 314.127;
21 CFR 601.2 and 601.20.
Jkt 253001
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Another guidance title referenced in COVID–19 guidance
—Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
—Requests for Expedited Review of New Drug Application
and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.
—Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA).
—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products.
—Changes to an Approved Application: Biological Products.
—Changes to an Approved NDA or ANDA; Questions and
Answers.
—Changes to an Approved NDA or ANDA.
—CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.
—Changes to an Approved Application: Biological Products:
Human Blood and Blood Components Intended for Transfusion or for Further Manufacture.
—CMC Postapproval Manufacturing Changes for Specified
Biological Products To Be Documented in Annual Reports.
—Chemistry, Manufacturing, and Controls Changes to an
Approved Application: Certain Biological Products.
—Immediate Release Solid Oral Dosage Forms; Scale-Up
and Postapproval Changes: Chemistry, Manufacturing, and
Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.
—SUPAC–IR: Questions and Answers about SUPAC–IR
Guidance.
Fmt 4703
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OMB control
Nos.
0910–0001
0910–0014
0910–0338
0910–0045
0910–0139
0910–0759
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
39051
TABLE 2—CDER GUIDANCES AND COLLECTIONS—Continued
COVID–19
guidance title
CFR cite
referenced in COVID–19
guidance
Another guidance title referenced in COVID–19 guidance
OMB control
Nos.
—SUPAC–SS: Nonsterile Semisolid Dosage Forms; ScaleUp and Postapproval Changes: Chemistry, Manufacturing,
and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.
—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.
—SUPAC: Manufacturing Equipment Addendum.
—Remote Interactive Evaluations of Drug Manufacturing and
Bioresearch Monitoring Facilities During the COVID–19
Public Health Emergency.
B. CBER 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:
TABLE 3—CBER GUIDANCES AND COLLECTIONS
COVID–19
guidance title
CFR cite referenced in COVID–19 guidance
Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated
May 2021).
21
21
21
21
21
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
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–15649 Filed 7–22–21; 8:45 am]
16:49 Jul 22, 2021
314.420 ......................................
part 312 .....................................
parts 210, 211, and 610 ............
part 600 .....................................
part 601 .....................................
Emergency Use Authorization of Medical
Products and Related Authorities.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
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CFR
CFR
CFR
CFR
CFR
Another guidance title referenced in
COVID–19 guidance
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OMB control
Nos.
0910–0001
0910–0014
0910–0139
0910–0308
0910–0338
0910–0595
Emphasis Panel; NINDS BRAIN Review
Meeting (U01 and R01 Applications).
Date: August 12–13, 2021.
Time: 10:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Mir Ahamed Hossain,
Ph.D., Scientific Review Officer, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Rockville, MD 20852,
(301) 496–9223, mirahamed.hossain@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: July 20, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–15744 Filed 7–22–21; 8:45 am]
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]]>Agencies
[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39048-39051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15649]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1137]
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 July 23, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
[[Page 39049]]
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.
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 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.
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, 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-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-
[[Page 39050]]
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
----------------------------------------------------------------------------------------------------------------
Contact information to
Docket No. Center Title of guidance request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1136..................... CDER.................... Manufacturing, Supply [email protected].
Chain, and Drug and Please include the
Biological Product docket number FDA-2020-
Inspections During D-1136 and complete
COVID-19 Public Health title of the guidance
Emergency Questions in the request.
and Answers (Updated
May 2021).
FDA-2020-D-1137..................... CBER.................... Emergency Use Office of
Authorization for Communication,
Vaccines to Prevent Outreach and
COVID-19 (Updated May Development, 10903 New
2021). Hampshire Ave., Bldg.
71, Rm. 3128, Silver
Spring, MD 20993-0002,
1-800-835-4709 or 240-
402-8010; email
[email protected].
----------------------------------------------------------------------------------------------------------------
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
COVID-19 guidance guidance Nos.
----------------------------------------------------------------------------------------------------------------
Manufacturing, Supply Chain, and Drug 21 CFR 314.50, 314.94, --Prioritization of the 0910-0001
and Biological Product Inspections 314.95, 314.125, Review of Original ANDAs, 0910-0014
During COVID-19 Public Health 314.127; 21 CFR 601.2 Amendments, and Supplements. 0910-0338
Emergency Questions and Answers and 601.20. --Requests for Expedited 0910-0045
(Updated May 2021). Review of New Drug 0910-0139
Application and Biologics 0910-0759
License Application Prior
Approval Supplements
Submitted for Chemistry,
Manufacturing, and Controls
Changes.
--Administrative Processing
of Original Biologics
License Applications (BLA)
and New Drug Applications
(NDA).
--Changes to an Approved
Application for Specified
Biotechnology and Specified
Synthetic Biological
Products.
--Changes to an Approved
Application: Biological
Products.
--Changes to an Approved NDA
or ANDA; Questions and
Answers.
--Changes to an Approved NDA
or ANDA.
--CMC Postapproval
Manufacturing Changes To Be
Documented in Annual Reports.
--Changes to an Approved
Application: Biological
Products: Human Blood and
Blood Components Intended
for Transfusion or for
Further Manufacture.
--CMC Postapproval
Manufacturing Changes for
Specified Biological
Products To Be Documented in
Annual Reports.
--Chemistry, Manufacturing,
and Controls Changes to an
Approved Application:
Certain Biological Products.
--Immediate Release Solid
Oral Dosage Forms; Scale-Up
and Postapproval Changes:
Chemistry, Manufacturing,
and Controls, In Vitro
Dissolution Testing, and In
Vivo Bioequivalence
Documentation.
--SUPAC-IR: Questions and
Answers about SUPAC-IR
Guidance.
[[Page 39051]]
--SUPAC-SS: Nonsterile
Semisolid Dosage Forms;
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and Controls;
In Vitro Release Testing and
In Vivo Bioequivalence
Documentation.
--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.
--SUPAC: Manufacturing
Equipment Addendum.
--Remote Interactive
Evaluations of Drug
Manufacturing and
Bioresearch Monitoring
Facilities During the COVID-
19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------
B. CBER 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:
Table 3--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance Nos.
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for Vaccines 21 CFR 314.420............ Emergency Use 0910-0001
to Prevent COVID-19 (Updated May 2021). 21 CFR part 312........... Authorization of Medical 0910-0014
21 CFR parts 210, 211, and Products and Related 0910-0139
610. Authorities.
21 CFR part 600........... 0910-0308
21 CFR part 601........... 0910-0338
0910-0595
----------------------------------------------------------------------------------------------------------------
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: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15649 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P
