[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10285-10289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03421]


-----------------------------------------------------------------------

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.

[[Page 10286]]


DATES: The announcement of the guidances is published in the Federal 
Register on February 19, 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.
     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: 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, Kimberly Thomas, Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357, or Erica 
Takai, Center for Devices and Radiological Health (CDRH), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver 
Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19, 
and after consultation with public health officials as necessary, the 
Secretary of Health and Human Services (HHS), pursuant to the authority 
under section 319 of the Public Health Service Act (42 U.S.C. 247d), 
determined that a PHE exists and has existed since January 27, 2020, 
nationwide.\1\ On March 13, 2020, there was a Presidential declaration 
that the COVID-19 outbreak in the United States constitutes a national 
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services, ``Determination that 
a Public Health Emergency Exists'' (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/.
---------------------------------------------------------------------------

    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-

[[Page 10287]]

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.

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-1825.................  CBER................  Investigational COVID-19     Office of Communication,
                                                         Convalescent Plasma          Outreach and Development,
                                                         (Updated January 2021).      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.
FDA-2020-D-1137.................  CBER................  Manufacturing                Office of Communication,
                                                         Considerations for           Outreach and Development,
                                                         Licensed and                 10903 New Hampshire Ave.,
                                                         Investigational Cellular     Bldg. 71, Rm. 3128, Silver
                                                         and Gene Therapy Products    Spring, MD 20993-0002, 1-
                                                         During COVID-19 Public       800-835-4709 or 240-402-
                                                         Health Emergency (January    8010; email
                                                         2021).                       ocod@fda.hhs.gov.
FDA-2020-D-1136.................  CDER................  Review Timelines for         druginfo@fda.hhs.gov.
                                                         Applicant Responses to       Please include the docket
                                                         Complete Response Letters    number FDA-2020-D-1136 and
                                                         When a Facility Assessment   complete title of the
                                                         Is Needed During the COVID-  guidance in the request.
                                                         19 Public Health Emergency
                                                         (December 2020).
FDA-2020-D-1136.................  CDER................  Protecting Participants in   druginfo@fda.hhs.gov.
                                                         Bioequivalence Studies for   Please include the docket
                                                         Abbreviated New Drug         number FDA-2020-D-1136 and
                                                         Applications During the      complete title of the
                                                         COVID-19 Public Health       guidance in the request.
                                                         Emergency (January 2021).
FDA-2020-D-1136.................  CDER................  COVID-19: Potency Assay      druginfo@fda.hhs.gov.
                                                         Considerations for           Please include the docket
                                                         Monoclonal Antibodies and    number FDA-2020-D-1136 and
                                                         Other Therapeutic Proteins   complete title of the
                                                         Targeting SARS-CoV-2         guidance in the request.
                                                         Infectivity (January 2021).
FDA-2020-D-1138.................  CDRH................  Coagulation Systems for      CDRH-Guidance@fda.hhs.gov.
                                                         Measurement of               Please include the
                                                         Viscoelastic Properties:     document number 20041-R1
                                                         Enforcement Policy During    and complete title of the
                                                         the Coronavirus Disease      guidance in the request.
                                                         2019 (COVID-19) Public
                                                         Health Emergency (January
                                                         2021).
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without 
prior comment, FDA will consider all comments received and revise the 
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (Sec.  10.115). The guidances represent 
the current thinking of FDA. They do not establish any rights for any 
person and are not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER 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 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 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--CBER 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
----------------------------------------------------------------------------------------------------------------
Investigational COVID-19 Convalescent  21 CFR part 312, 21 CFR  Form FDA 3926..........  0910-0014, 0910-0116,
 Plasma; Guidance for Industry          parts 606 and 630.                                0910-0814.
 (Updated: January 15, 2021).
Manufacturing Considerations for       21 CFR 1271.50, 21 CFR   .......................  0910-0543, 0910-0139,
 Licensed and Investigational           part 211, 21 CFR part                             0910-0014, 0910-0338,
 Cellular and Gene Therapy Products     312 (INDs), 21 CFR                                0910-0001.
 During COVID-19 Public Health          part 601 (BLAs), 21
 Emergency (January 2021).              CFR 314.420 (Master
                                        Files).
----------------------------------------------------------------------------------------------------------------


[[Page 10288]]

B. CDER Guidances

    While these guidances contain no collection of information, they do 
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 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 3--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
----------------------------------------------------------------------------------------------------------------
Review Timelines for Applicant         21 CFR 314.3(b), 21 CFR  Manufacturing, Supply    0910-0001, 0910-0338,
 Responses to Complete Response         600.3 and 600.21, 21     Chain, and Drug and      0910-0139.
 Letters When a Facility Assessment     CFR 601.20(d).           Biological Product
 Is Needed During the COVID-19 Public                            Inspections During
 Health Emergency (December 2020).                               COVID-19 Public Health
                                                                 Emergency: Questions
                                                                 and Answers.
Protecting Participants in             21 CFR 50, 21 CFR 312,   Referencing Approved     0910-0001, 0910-0014,
 Bioequivalence Studies for             21 CFR 314.3, 21 CFR     Drug Products in ANDA    0910-0130, 0910-0139,
 Abbreviated New Drug Applications      314.101, 21 CFR          Submissions.             0910-0303, 0910-0572,
 During the COVID-19 Public Health      314.105, 21 CFR 320.1,  Bioequivalence Studies    0910-0755, 0910-0797.
 Emergency.                             21 CFR 320.23(b), 21     With Pharmacokinetic
                                        CFR 320.24-26, 21 CFR    Endpoints for Drugs
                                        320.31, 21 CFR 314.94,   Submitted Under an
                                        314.101, 314.105.        Abbreviated New Drug
                                                                 Application.
                                                                Conduct of Clinical
                                                                 Trials of Medical
                                                                 Products during the
                                                                 COVID-19 Public Health
                                                                 Emergency.
                                                                ANDA Submissions--
                                                                 Content and Format of
                                                                 Abbreviated New Drug
                                                                 Application.
                                                                Controlled
                                                                 Correspondence Related
                                                                 to Generic Drug
                                                                 Development.
                                                                Formal Meetings Between
                                                                 FDA and ANDA
                                                                 Applicants of Complex
                                                                 Products Under GDUFA.
                                                                Use of Electronic
                                                                 Informed Consent in
                                                                 Clinical
                                                                 Investigations--Questi
                                                                 ons and Answers.
                                                                Oversight of Clinical
                                                                 Investigations--A Risk-
                                                                 Based Approach to
                                                                 Monitoring.
COVID-19: Potency Assay                21 CFR 211.165, 21 CFR   ICH guidance for         0910-0001, 0910-0014,
 Considerations for Monoclonal          211.194, 21 CFR 601.2,   Industry Q6B             0910-0338, 0910-0139,
 Antibodies and Other Therapeutic       21 CFR 610.3, 21 CFR     Specifications: Test     0910-0303.
 Proteins Targeting SARS-CoV-2          610.10.                  Procedures and
 Infectivity.                                                    Acceptance Criteria
                                                                 for Biotechnological/
                                                                 Biological Products.
                                                                Analytical Procedures
                                                                 and Methods Validation
                                                                 for Drugs and
                                                                 Biologics.
                                                                ICH guidance for
                                                                 industry Q2(R1)
                                                                 Validation of
                                                                 Analytical Procedures:
                                                                 Text and Methodology.
                                                                Emergency Use
                                                                 Authorization of
                                                                 Medical Products and
                                                                 Related Authorities.
                                                                Bioanalytical Method
                                                                 Validation.
                                                                ICH guidance for
                                                                 industry M4Q: The CTD--
                                                                 Quality.
                                                                ICH guidance for
                                                                 industry Q5C Quality
                                                                 of Biotechnological
                                                                 Products: Stability
                                                                 Testing of
                                                                 Biotechnological/
                                                                 Biological Products.
                                                                ICH guidance for
                                                                 industry Q8(R2)
                                                                 Pharmaceutical
                                                                 Development.
----------------------------------------------------------------------------------------------------------------


[[Page 10289]]

C. CDRH Guidance

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information (listed in 
table 4). 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 have 
been approved by OMB as listed in the following table:

                                     Table 4--CDRH Guidance 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
----------------------------------------------------------------------------------------------------------------
Coagulation Systems for Measurement    800, 801, and 809......  .......................  0910-0485.
 of Viscoelastic Properties:           807, subparts A through                           0910-0625.
 Enforcement Policy During the          D.                                               .......................
 Coronavirus Disease 2019 (COVID-19)   807, subpart E.........                           0910-0120.
 Public Health Emergency (January      803....................                           0910-0437.
 2021).                                806....................                           0910-0359.
                                       820....................                           0910-0073.
----------------------------------------------------------------------------------------------------------------

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: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03421 Filed 2-18-21; 8:45 am]
BILLING CODE 4164-01-P


