Notice2021-21798
Guidance Documents Related to Coronavirus Disease 2019; Availability
Primary source
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Published
October 6, 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. FDA is also announcing the withdrawal of two FDA guidance documents related to the COVID-19 PHE.
Full Text
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<title>Federal Register, Volume 86 Issue 191 (Wednesday, October 6, 2021)</title>
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[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55620-55623]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21798]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1138]
Guidance Documents Related to Coronavirus Disease 2019;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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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. FDA is also announcing the withdrawal of two FDA guidance
documents related to the COVID-19 PHE.
DATES: The announcement of the guidances is published in the Federal
Register on October 6, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<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
[[Page 55621]]
anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on <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 Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
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\1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists Nationwide as the Result of the
2019 Novel Coronavirus'' (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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>).
The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.
[[Page 55622]]
II. Availability of COVID-19-Related Guidance Documents
Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:
Table 1--Guidances Related to the COVID-19 Public Health Emergency
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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.................. Development of Abbreviated <a href="/cdn-cgi/l/email-protection#f89c8a8d9f91969e97b89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="3f5b4d4a58565159507f595b5e1157574c11585049">[email protected]</span></a>. Please
New Drug Applications During include the docket number
the COVID-19 Pandemic-- FDA-2020-D-1136 and complete
Questions and Answers; title of the guidance in the
Guidance for Industry request.
(Updated September 2021).
FDA-2020-D-1138........... CDRH.................. Enforcement Policy for Face <a href="/cdn-cgi/l/email-protection#c58681978de882b0aca1a4aba6a085a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="adeee9ffe580ead8c4c9ccc3cec8edcbc9cc83c5c5de83cac2db">[email protected]</span></a>.
Masks, Barrier Face Please include the document
Coverings, Face Shields, number 20018 and complete
Surgical Masks, and title of the guidance in the
Respirators During the request.
Coronavirus Disease (COVID-
19) Public Health Emergency
(Updated September 2021).
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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 No(s).
COVID-19 guidance guidance
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Development of Abbreviated New Drug 21 CFR 211.170, 21 CFR (1) ANDAs: Stability 0910-0001, 0910-0014,
Applications During the COVID-19 314.3, 21 CFR 314.50, Testing of Drug Substances 0910-0119, 0910-0139,
Pandemic--Questions and Answers; 21 CFR 314.94, 21 CFR and Products, Questions 0910-0338, 0910-0581,
Guidance for Industry (Updated 314.101, 21 CFR and Answers. 0910-0672, 0910-0733,
September 2021). 314.105, 21 CFR (2) Referencing Approved 0910-0797.
314.107, 21 CFR Drug Products in ANDA
320.25, 21 CFR Submissions.
320.31, 21 CFR (3) Protecting Participants
320.38, 21 CFR 320.63. in Bioequivalence Studies
for Abbreviated New Drug
Applications During the
COVID-19 Public Health
Emergency.
(4) Safety Reporting
Requirements for INDs and
BA/BE Studies.
(5) Controlled
Correspondence Related to
Generic Drug Development.
(6) Formal Meetings Between
FDA and ANDA Applicants of
Complex Products Under
GDUFA.
(5) Controlled
Correspondence Related to
Generic Drug Development.
(7) Conduct of Clinical
Trials of Medical Products
during the COVID-19
Pandemic.
(8) ANDAs: Stability
Testing of Drug Substances
and Products, Questions
and Answers.
(9) Manufacturing, Supply
Chain, and Drug and
Biological Product
Inspections During COVID-
19 Public Health Emergency
Questions and Answers.
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B. CDRH Guidance
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:
[[Page 55623]]
Table 3--CDRH Guidances and Collections
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Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
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Enforcement Policy for Face Masks and 800, 801, and 809......... 0910-0485
Respirators During the Coronavirus 803....................... 0910-0437
Disease (COVID-19) Public Health 806....................... 0910-0359
Emergency (Revised); Guidance for 807, subpart E............ 0910-0120
Industry and Food and Drug
Administration Staff.
807, subparts A through D. 0910-0625
820....................... 0910-0073
830 and 801.20............ 0910-0720
Emergency Use 0910-0595
Authorization of Medical
Products and Related
Authorities; Guidance for
Industry and Other
Stakeholders.
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IV. Withdrawn COVID-19-Related Guidance Documents
On June 30, 2021, FDA announced the revocation of the Emergency Use
Authorizations (EUAs) for Decontamination and Bioburden Reduction
Systems for Personal Protective Equipment. The full text of the
revocations are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
(Docket No. FDA-2021-N-0762) and <a href="https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations">https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations</a>. With the revocation of these
EUAs, on June 30, 2021, FDA also withdrew two related decontamination
and bioburden reduction guidance documents (listed in table 4), as the
documents no longer represent the Agency's current thinking.
Table 4--Withdrawn Guidances Related to the COVID-19 Public Health Emergency
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Docket No. Center Title of withdrawn guidance Withdrawal date
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FDA-2020-D-1138..................... CDRH Recommendations for Sponsors June 30, 2021.
Requesting EUAs for
Decontamination and Bioburden
Reduction Systems for Face Masks
and Respirators During the
Coronavirus Disease 2019 (COVID-
19) Public Health Emergency;
Guidance for Industry and Food and
Drug Administration Staff.
FDA-2020-D-1138..................... CDRH Enforcement Policy for Bioburden June 30, 2021.
Reduction Systems Using Dry Heat
to Support Single-User Reuse of
Certain Filtering Facepiece
Respirators During the Coronavirus
Disease (2019) Public Health
Emergency.
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These withdrawn guidance documents are presented on FDA's website,
for historical purposes only, at <a href="https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-guidance">https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-guidance</a>.
V. 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: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21798 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P
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