Federal Register, Volume 85 Issue 124 (Friday, June 26, 2020)

[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38372-38378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13829]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1138, FDA-
2020-D-1139, FDA-2020-D-1140]

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 guidance documents 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 June 26, 2020. The guidance documents 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

[[Page 38373]]

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 21 CFR
10.115(g)(5)).
Submit written requests for single copies of these guidances to the
addresses 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 documents.

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; Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, HFZ-450, Silver Spring, MD 20993-0002, 301-796-6353; Phil
Chao, Center for Food Safety and Applied Nutrition (CFSAN), CPK1 Rm.
1C001, HFS-024, Food and Drug Administration, College Park, MD 20740,
240-402-2112; Diane Heinz, Center for Veterinary Medicine (CVM), Food
and Drug Administration, MPN2 RME435 HFV-6, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-5692.

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. 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 (March 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 guidance documents 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 guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents 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
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidance
documents FDA issued during the relevant period, as included in table
1. This notice announces COVID-19-

[[Page 38374]]

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
guidance documents:

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-1138..................... CDRH.................. Notifying CDRH of CDRH-
Permanent [email protected].
Discontinuance or Please include the
Interruption in document number 20032
Manufacturing of a and complete title of
Device Under Section the guidance in the
506J of the FD&C Act request.
During the COVID-19
Public Health Emergency
(May 6, 2020).
FDA-2020-D-1138..................... CDRH.................. Supplements for Approved CDRH-
Premarket Approval [email protected].
(PMA) or Humanitarian Please include the
Device Exemption (HDE) document number 20028
Submissions During the and complete title of
Coronavirus Disease the guidance in the
2019 (COVID-19) Public request.
Health Emergency (May
21, 2020).
FDA-2020-D-1138..................... CDRH.................. Enforcement Policy for CDRH-
Face Masks and [email protected].
Respirators During the Please include the
Coronavirus Disease document number 20018
(COVID-19) Public and complete title of
Health Emergency (April the guidance in the
2020) (Updated May 26, request.
2020).
FDA-2020-D-1138..................... CDRH.................. Recommendations for CDRH-
Sponsors Requesting [email protected].
EUAs for Please include the
Decontamination and document number 20033
Bioburden Reduction and complete title of
Systems for Face Masks the guidance in the
and Respirators During request.
the Coronavirus Disease
(COVID-19) Public
Health Emergency (May
26, 2020).
FDA-2020-D-1136..................... CDER.................. Exemption and Exclusion [email protected].
of Certain Requirements Please include the
of the Drug Supply docket number FDA-2020-
Chain Security Act D-1136 and complete
During the COVID-19 title of the guidance
Public Health Emergency in the request.
(April 30, 2020).
FDA-2020-D-1136..................... CDER.................. COVID-19 Public Health [email protected].
Emergency: General Please include the
Considerations for Pre- docket number FDA-2020-
IND Meeting D-1136 and complete
Requirements for COVID- title of the guidance
19 Related Drugs and in the request.
Biological Products
(May 11, 2020).
FDA-2020-D-1136..................... CDER.................. Temporary Policy [email protected].
Regarding Non-Standard Please include the
PPE Practices for docket number FDA-2020-
Sterile Compounding by D-1136 and complete
Pharmacy Compounders title of the guidance
not Registered as in the request.
Outsourcing Facilities
During the COVID-19
Public Health Emergency
(April 10, 2020)
(Updated May 14, 2020).
FDA-2020-D-1136..................... CDER.................. Temporary Policy for [email protected].
Compounding of Certain Please include the
Drugs for Hospitalized docket number FDA-2020-
Patients by Outsourcing D-1136 and complete
Facilities During the title of the guidance
COVID-19 Public Health in the request.
Emergency (April 2020)
(Updated May 21, 2020).
FDA-2020-D-1136..................... CDER.................. Temporary Policy for [email protected].
Compounding of Certain Please include the
Drugs for Hospitalized docket number FDA-2020-
Patients by Pharmacy D-1136 and complete
Compounders not title of the guidance
Registered as in the request.
Outsourcing Facilities
During the COVID-19
Public Health Emergency
(April 2020) (Updated
May 21, 2020).
FDA-2020-D-1136..................... CDER.................. Effects of the COVID-19 [email protected].
Public Health Emergency Please include the
on Formal Meetings and docket number FDA-2020-
User Fee Applications-- D-1136 and complete
Questions and Answers title of the guidance
(May 26, 2020). in the request.
FDA-2020-D-1106..................... CDER.................. FDA Guidance on Conduct clinicaltrialconduct-
of Clinical Trials of [email protected].
Medical Products during Please include the
COVID-19 Public Health docket number FDA-2020-
Emergency (March 2020) D-1106 and complete
(Updated May 14 and title of the guidance
June 3, 2020). in the request.
FDA-2020-D-1139..................... CFSAN................. Returning Refrigerated Retail Food Protection
Transport Vehicles and Staff, Office of Food
Refrigerated Storage Safety, Center for Food
Units to Food Uses Safety and Applied
After Using Them to Nutrition, Food and
Preserve Human Remains Drug Administration,
During the COVID-19 5001 Campus Dr.,
Pandemic (May 12, 2020). College Park, MD 20740.
FDA-2020-D-1139..................... CFSAN................. Temporary Policy Office of Nutrition and
Regarding Certain Food Food Labeling, Food
Labeling Requirements Labeling and Standards
During the COVID-19 Staff, Center for Food
Public Health Safety and Applied
Emergency: Minor Nutrition, Food and
Formulation Changes and Drug Administration,
Vending Machines (May 5001 Campus Dr.,
22, 2020). College Park, MD 20740.
FDA-2020-D-1140..................... CVM................... GFI# 271 Reporting and [email protected].
Mitigating Animal Drug Please include the
Shortages during the docket number FDA-2020-
COVID-19 Public Health N-1140 and complete
Emergency (May 7, 2020). title of the guidance
in the request.
----------------------------------------------------------------------------------------------------------------

Although these guidance documents 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

[[Page 38375]]

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. CDRH Guidances

The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

Table 2--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Supplements for Approved Premarket Approval 21 CFR part 814, subparts 0910-0231
(PMA) or Humanitarian Device Exemption A through E. 0910-0332
(HDE) Submissions During the Coronavirus 21 CFR part 814, subpart 0910-0073
Disease 2019 (COVID-19) Public Health H.
Emergency. 21 CFR part 820..........
21 CFR parts 800, 801, ........................ 0910-0485
and 809.
Recommendations for Sponsors Requesting 21 CFR part 803.......... ........................ 0910-0437
EUAs for Decontamination and Bioburden Emergency Use 0910-0595
Reduction Systems for Face Masks and Authorization of
Respirators During the Coronavirus Disease Medical Products and
2019 (COVID-19) Public Health Emergency. Related Authorities.
Enforcement Policy for Face Masks and 21 CFR parts 800, 801, ........................ 0910-0485
Respirators During the Coronavirus Disease and 809. ........................ ..............
(COVID-19) Public Health Emergency. 21 CFR part 803.......... ........................ 0910-0437
21 CFR part 806.......... ........................ 0910-0359
21 CFR part 807, subpart ........................ 0910-0120
E.
21 CFR part 807, subparts ........................ 0910-0625
A through D.
21 CFR part 820.......... ........................ 0910-0073
21 CFR part 830 and ........................ 0910-0720
801.20.
Emergency Use 0910-0595
Authorization of
Medical Products and
Related Authorities.
----------------------------------------------------------------------------------------------------------------

The guidance indicated in the table below refers to previously
approved collections of information. These 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 table. This guidance also contains a
new collection of information not approved under a current collection.
This new 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--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control New collection covered by PHE
title in COVID-19 guidance 19 guidance No(s). PRA waiver
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of 21 CFR part 807, 0910-0625
Permanent subparts A through D. .................... ...........
Discontinuance or Emergency Use 0910-0595
Interruption in Authorization of
Manufacturing of a Medical Products
Device Under Section and Related
506J of the FD&C Act Authorities;
During the COVID-19 Guidance for
Public Health Industry and Other
Emergency. Stakeholders.
Notifications to FDA about
changes in the production of
certain medical device
products that will help the
Agency prevent or mitigate
shortages of such devices
during the COVID-19 PHE.
Updates to FDA every 2 weeks
after initial notification on
the shortage situation,
including the expected
timeline for recovery.
Voluntary submission of other
information that enables FDA
to work more effectively with
manufacturers and other
entities to prevent or limit
any negative impact on
patients or healthcare
providers during the COVID-19
PHE.
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[[Page 38376]]

B. CDER Guidances

Table 4--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 No(s).
----------------------------------------------------------------------------------------------------------------
Effects of the COVID-19 Public Health Sec. 10.115(g)(2)...... Planning for the Effects of 0910-0001
Emergency on Formal Meetings and User High Absenteeism to Ensure 0910-0014
Fee Applications.. Availability of Medically 0910-0429
Necessary Drug Products. 0910-0693
Formal Meetings Between the 0910-0718
FDA and Sponsors or 0910-0719
Applicants of PDUFA Products. 0910-0727
Formal Meetings Between the
FDA and Sponsors or
Applicants of BsUFA Products.
Exemption and Exclusion of Certain ......................... Drug Supply Chain Security 0910-0777
Requirements of the Drug Supply Chain Act Implementation: 0910-0800
Security Act During the COVID-19 Identification of Suspect 0910-0806
Public Health Emergency.. Product and Notification. 0910-0827
Verification Systems Under 0910-0859
the Drug Supply Chain
Security Act for Certain
Prescription Drugs.
Definitions of Suspect
Product and Illegitimate
Product for Verification
Obligations Under the Drug
Supply Chain Security Act.
General Considerations for Pre-IND 21 CFR part 312.......... COVID-19: Developing Drugs 0910-0001
Meeting Requirements for COVID-19 and Biological Products for 0910-0014
Related Drugs and Biological Treatment or Prevention. 0910-0338
Products.. Formal Meetings Between the 0910-0429
FDA and Sponsors or 0910-0595
Applicants of PDUFA Products. 0910-0719
Emergency Use Authorization
of Medical Products and
Related Authorities.
Preclinical Assessment of 0910-0814
Investigational Cellular and
Gene Therapy Products.
Guidance for Clinical Trial
Sponsors: Establishment and
Operation of Clinical Trial
Data Monitoring Committees.
Use of Liquids and/or Soft
Foods as Vehicles for Drug
Administration: General
Considerations for Selection
and In Vitro Methods for
Product Quality Assessments.
Demonstrating Substantial
Evidence of Effectiveness
for Human Drug and
Biological Products.
----------------------------------------------------------------------------------------------------------------

The guidances listed in the table below refer to previously
approved collections of information. These 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 below table. These guidances also
contain new collections of information not approved under a current
collection. These new collections of information have been granted a
PHE waiver from the PRA by 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 5-- CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control No(s). covered by PHE PRA
title in COVID-19 guidance 19 guidance waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy for 21 CFR 314.81, 21 Current Good 0910-0777, 0910- To provide
Compounding of CFR 600.82. Manufacturing 0338, 0910-0001, suitability and
Certain Drugs for Practice--Guidance 0910-0139. proof of sterility
Hospitalized Patients for Human Drug for the container
by Outsourcing Compounding closure systems
Facilities During the Outsourcing used.
COVID-19 Public Facilities Under
Health Emergency. Section 503B of the
FD&C Act.
Temporary Policy for .................... Compounded Drug 0910-0001, 0910- For reporting of
Compounding of Products That are 0139, 0910-0338. adverse events by
Certain Drugs for Essentially Copies pharmacy compounders
Hospitalized Patients of a Commercially to the MedWatch
by Pharmacy Available Drug system and
Compounders not Product under maintaining records
Registered as Section 503A of the of drugs suppliers
Outsourcing Federal Food, Drug, and patients who
Facilities During the and Cosmetic Act. receive the
COVID-19 Public Temporary Policy for compounded products.
Health Emergency. Compounding of
Certain Drugs for
Hospitalized
Patients by
Outsourcing
Facilities During
the COVID-19 Public
Health Emergency.
Prescription
Requirement Under
Section 503A of the
Federal Food, Drug,
and Cosmetic Act.

[[Page 38377]]

Temporary Policy
Regarding Non-
Standard PPE
Practices for
Sterile Compounding
by Pharmacy
Compounders not
Registered as
Outsourcing
Facilities during
the COVID-19 Public
Health Emergency.
Temporary Policy 21 CFR parts 210 and Enforcement Policy 0910-0139........... Recordkeeping of
Regarding Non- 211. for Face Masks and compounding
Standard PPE Respirators During performed without
Practices for Sterile the Coronavirus standard PPE;
Compounding by Disease (COVID-19) recordkeeping of any
Pharmacy Compounders Public Health change of
not Registered as Emergency (Revised). sterilization/
Outsourcing Enforcement Policy aseptic processing
Facilities During the for Gowns, Other methods;
COVID-19 Public Apparel, and Gloves documentation of
Health Emergency. During the mitigation
Coronavirus Disease strategies for
(COVID-19) Public sterile compounding
Health Emergency. without standard
PPE.
Electronic Drug
Product Reporting
for Human Drug
Compounding
Outsourcing
Facilities Under
Section 503B of the
Federal Food, Drug,
and Cosmetic Act.
Guidance on Conduct of 21 CFR part 11, 21 Formal Meetings 0910-0001, 0910- Submission by
Clinical Trials of CFR part 50, 21 CFR Between the FDA and 0014, 0910-0130, investigators of
Medical Products part 56, 21 CFR Sponsors or 0910-0303, 0910- informed consent
during COVID-19 part 312, 21 CFR Applicants of PDUFA 0338, 0910-0119, forms to third
Public Health part 314, 21 CFR Products. 0910-0581, 0910- parties.
Emergency. part 601, 21 CFR Formal Meetings 0733, 0910-0078.
part 812. Between the FDA 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--Eligibi
lity 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.

[[Page 38378]]

Requests for Feedback
and Meetings for
Medical Device
Submissions: The Q-
Submission Program.
----------------------------------------------------------------------------------------------------------------

C. CFSAN Guidance

The guidance indicated in the table below refers to previously
approved collections of information. These 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 table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by the 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 6--CFSAN Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control No(s). covered by PHE PRA
title in COVID-19 guidance 19 guidance waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy 21 CFR part 101; .................... 0910-0381, 0910- Recommend that
Regarding Certain section 403(w) of 0782, 0910-0792. manufacturers post
Mandatory Food the FD&C Act. ingredient omissions
Labeling Requirements or substitutions not
During the COVID-19 reflected on the
Public Health product label.
Emergency: Minor
Formulation Changes
and Vending Machines.
----------------------------------------------------------------------------------------------------------------

The guidance entitled ``Returning Refrigerated Transport Vehicles
and Refrigerated Storage Units to Food Uses After Using Them to
Preserve Human Remains During the COVID-19 Pandemic'' contains no
collection of information. Therefore, clearance by OMB under the PRA is
not required.

D. CVM Guidance

This guidance indicated in the table below refers to previously
approved collections of information. These 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 indicated in the table. This guidance also contains
a new collection of information not approved under a current
collection. This new collection of information has been granted a PHE
waiver from the PRA by 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 7--CVM Guidance and Collection
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control No(s). covered by PHE PRA
title in COVID-19 guidance 19 guidance waiver
----------------------------------------------------------------------------------------------------------------
GFI# 271, Reporting 21 CFR 514.1(a))..... .................... 0910-0032, 0910-0669 Reporting and
and Mitigating Animal mitigating animal
Drug Shortages during drug shortages.
the COVID-19 Public
Health Emergency.
----------------------------------------------------------------------------------------------------------------

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.

Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13829 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P