Notice2021-15649
Guidance Documents Related to Coronavirus Disease 2019; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39048-39051]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15649]
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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.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.
DATES: The announcement of the guidances is published in the Federal
Register on 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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\
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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: <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx</a>.
\2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: <a href="https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/">https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/</a>. 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
<a href="https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic">https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic</a>.
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In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at <a href="https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf">https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf</a>), 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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>)
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
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Contact information to
Docket No. Center Title of guidance request single copies
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FDA-2020-D-1136..................... CDER.................... Manufacturing, Supply <a href="/cdn-cgi/l/email-protection#1c786e697b75727a735c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="caaeb8bfada3a4aca58aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a>.
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
<a href="/cdn-cgi/l/email-protection#ddb2beb2b99dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="e18e828e85a1878580cf898992cf868e97">[email protected]</span></a>.
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Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec. 10.115(g)(3)).
These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
III. Paperwork Reduction Act of 1995
A. 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
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Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance Nos.
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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.
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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
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Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance 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
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IV. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at:
<bullet> FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders">https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders</a>.
<bullet> FDA web page entitled ``Search for FDA Guidance
Documents'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>; or
<bullet> <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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