[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65820-65824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1106]
Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); 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 October 16, 2020. The guidances have been implemented
without prior comment, but they remain subject to comment in accordance
with the Agency's good guidance practices.
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
[[Page 65821]]
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 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 guidances.
FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247d) (PHS Act), determined that a PHE exists and has existed since
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J.
Trump declared that the COVID-19 outbreak in the United States
constitutes a national emergency, beginning March 1, 2020.\2\
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\1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020; on July 23, 2020, it was extended,
effective July 25, 2020; on October 2, 2020, it was extended,
effective October 23, 2020. These PHE Determinations are 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 (Mar. 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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In the Federal Register of March 25, 2020 (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 (FD&C Act) (21 U.S.C.
371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec. 10.115(g)(2))). The
guidances are available at FDA's web page entitled ``COVID-19-Related
Guidance Documents for 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) and through FDA's web page entitled ``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
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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 druginfo@fda.hhs.gov.
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 (August
2020).
FDA-2020-D-1136.................. CDER....................... Resuming Normal Drug druginfo@fda.hhs.gov.
and Biologics Please include the
Manufacturing docket number FDA-2020-
Operations During the D-1136 and complete
COVID-19 Public Health title of the guidance
Emergency (September in the request.
2020).
FDA-2020-D-1106.................. CDER....................... FDA Guidance on Conduct Clinicaltrialconduct-
of Clinical Trials of [email protected]
Medical Products Please include the
during COVID-19 Public docket number FDA-2020-
Health Emergency D-1106 and complete
(March 2020) (Updated title of the guidance
September 2020). in the request.
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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
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guidances represent the current thinking of FDA. They do not establish
any rights for any person and are not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
CDER Guidances
The guidances listed in the table below refer to previously
approved FDA collections of information. 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. However, these 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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Guidance for Industry: Resuming 21 CFR 210 and 211, 21 --Q7 Good Manufacturing 0910-0001, 0910-0032,
Normal Drug and Biologics CFR 514.80, 21 CFR Practice Guidance for 0910-0139, 0910-0338,
Manufacturing Operations During 600. Active Pharmaceutical 0910-0669, 0910-0675,
the COVID-19 Public Health Ingredients. 0910-0759, 0910-0806.
Emergency. --Planning for the Effects
of High Absenteeism to
Ensure Availability of
Medically Necessary Drug
Products..
--Notifying FDA of a
Permanent Discontinuance
or Interruption in
Manufacturing Under
Section 506C of the FD&C
Act..
--Reporting and Mitigating
Animal Drug Shortages
During the COVID-19 Public
Health Emergency..
Manufacturing, Supply Chain, and 21 CFR 314.50; 314.95, --Prioritization of the 0910-0001, 0910-0014,
Drug and Biological Product 314.125, 314.127; Review of Original ANDAs, 0910-0338, 0910-0045,
Inspections During COVID-19 Public 601.2 and 601.20. Amendments, and 0910-0139, 0910-0759.
Health Emergency; Questions and Supplements.
Answers. --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.
--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.
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--SUPAC: Manufacturing
Equipment Addendum.
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The guidance listed in the table below refers to previously
approved FDA collections of information. Therefore, clearance by OMB
under the PRA is not required for this guidance. However, these
collections of information are subject to review by OMB under the PRA.
The previously approved collections of information in the following FDA
regulations and guidance have been approved by OMB as listed in the
table below. This guidance also contains a collection of information
not approved under a current collection. This collection of information
has been granted a PHE waiver from the PRA by the Department of Health
and Human Services (HHS) on March 19, 2020, under section 319(f) of the
PHS Act. Information concerning the PHE PRA waiver can be found on the
HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.
Table 3--CDER Guidances and Collections
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CFR cite Another guidance
COVID-19 guidance title referenced in referenced in OMB control No(s). Collection covered
COVID-19 guidance COVID-19 guidance by PHE PRA waiver
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Guidance on Conduct of Clinical 21 CFR part 11, 21 Formal Meetings 0910-0001, 0910- Submission by
Trials of Medical Products CFR part 50, 21 Between the FDA 0014, 0910-0130, investigators of
during COVID-19 Public Health CFR part 56, 21 and Sponsors or 0910-0303, 0910- informed consent
Emergency (Updated September CFR part 312, 21 Applicants of 0338, 0910-0119, forms to third
21, 2020). CFR part 314, 21 PDUFA Products. 0910-0581, 0910- parties.
CFR part 320, 21 Formal Meetings 0733, 0910-0078
CFR part 601, 21 Between the FDA
CFR part 812. and Sponsors or
Applicants of
BsUFA Products..
Pediatric Study
Plans: Content of
and Process for
Submitting
Initial Pediatric
Study Plans and
Amended Pediatric
Study Plans..
Draft Guidance for
Industry on
Demonstrating
Substantial
Evidence of
Effectiveness for
Human Drug and
Biological
Products..
Enhancing the
Diversity of
Clinical Trial
Populations--Elig
ibility Criteria,
Enrollment
Practices, and
Trial Design..
Pregnant Women:
Scientific and
Ethical
Considerations
for Inclusion in
Clinical Trials..
Part 11,
Electronic
Records;
Electronic
Signatures Scope
and Application..
Use of Electronic
Records and
Electronic
Signatures in
Clinical
Investigations
under 21 CFR Part
11--Questions and
Answers.
Safety Reporting
Requirements for
INDs and BA/BE
Studies..
Adverse Event
Reporting to
IRBs--Improving
Human Subject
Protection..
Use of Electronic
Informed Consent
In Clinical
Investigations..
E6(R2) Good
Clinical
Practice:
Integrated
Addendum to ICH
E6(R1)..
Providing
Regulatory
Submissions in
Electronic
Format--Certain
Human
Pharmaceutical
Product
Applications and
Related
Submissions Using
the eCTD
Specifications..
Best Practices for
Communication
Between IND
Sponsors and FDA
During Drug
Development..
Requests for
Feedback and
Meetings for
Medical Device
Submissions: The
Q-Submission
Program..
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IV. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at:
The 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;
the 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.
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Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22968 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P